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Cymbalta
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Withdrawal
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Cymbalta
withdrawal. Cymbalta
withdrawal side effects,
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withdrawal warnings,
Cymbalta
withdrawal precautions,
Cymbalta
withdrawal adverse effects, overdose, withdrawal symptoms and
Cymbalta
natural alternatives. Before you begin the spiral down with
Cymbalta
, try giving your body what it really wants.
Cymbalta

If you are struggling with Cymbalta side
effects, want to taper off Cymbalta, have already started to reduce Cymbalta or
quit Cymbalta cold turkey, there is help and there is a solution.
The bestselling book,
How to Get Off Cymbalta Safely details how to eliminate Cymbalta side
effects, how to safely taper off Cymbalta, what to do if you have already
started to taper off Cymbalta and are suffering and what you can do if you went
off Cymbalta too fast and are suffering the Cymbalta side effects.
This 288 page paperback book is easy to read but technical in
the right areas to share with your physician. This successful method of handling
these unwanted Cymbalta side effects is used by leading psychiatrists and
medical doctors worldwide. The book also includes chapters detailing how to get
off benzodiazepines and antipsychotics.
In March 2009 the American Medical Association acknowledged
antidepressant medications do come with withdrawal side effects and up to 20% of
the population will suffer these symptoms while trying to discontinue the
medication.
How to Get Off
Cymbalta Safely is available at Amazon.com and Target.com. Both stores sell
the book for $18.95
Click here to go to Amazon.com.
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Warning:
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collectors item or in short supply. For a change you can purchase something new
for less money than something used.
A quote from the book:
“I am now more than halfway off my antidepressant, using the
program. I was able to reduce a little bit of the medication with my naturopath,
but we reached a standstill after the second reduction. The side effects started
and we could not get rid of them. The Omega 3 got rid of the brain zaps within a
few hours and they never came back. The Body Calm has been amazing at helping me
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J.S.
New York
The anxiety, insomnia, fatigue or head symptoms that are usually associated with
Cymbalta withdrawal or the common Cymbalta side effects can be a thing of the
past.
Read Cymbalta side effects defined.
Note: These Cymbalta side effects are also Cymbalta withdrawal side effects.
Cymbalta -
Alert from the F.D.A.
FDA ALERT [07/2005]: Suicidal Thoughts or Actions in
Children and Adults
Patients with depression or other mental illnesses often
think about or attempt suicide. Closely watch anyone taking antidepressants,
especially early in treatment or when the dose is changed. Patients who become
irritable or anxious, or have new or increased thoughts of suicide or other
changes in mood or behavior (or their care givers) should contact their
healthcare professional right away.
Children
Taking antidepressants may increase suicidal thoughts and actions in about 1
out of 50 people 18 years or younger. FDA has approved Zoloft for use in
children only if they have obsessive-compulsive disorder.
Adults
Several recent scientific publications report the possibility of an increased
risk for suicidal behavior in adults who are being treated with antidepressant
medications. Even before these reports became available, FDA began a complete
review of all available data to determine whether there is an increased risk of
suicidal thinking or behavior in adults being treated with antidepressant
medications. It is expected that this review will take a year or longer to
complete. In the meantime, FDA is highlighting that adults being treated with
antidepressant medication, particularly those being treated for depression,
should be watched closely for worsening of depression and for increased suicidal
thinking or behavior.
This information reflects FDA’s preliminary
analysis of data concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this sheet when
additional information or analyses become available.
Cymbalta withdrawal
Body
Cymbalta
withdrawal Dry Mouth
- The
usual amount to moisture in the mouth is noticeably less.
Cymbalta
withdrawal Sweating
Increased -
A large
quantity of perspiration that is medically caused.
Cymbalta withdrawal
Cardiovascular (Involving the heart and the blood
vessels)
Cymbalta
withdrawal Palpitation
- Unusual and not normal heartbeat,
that is sometimes irregular, but rapid and forceful thumping or fluttering. It
can be brought on by shock, excitement, exertion, or medical stimulants. A
person is normally unaware of his/her heartbeat.
Cymbalta withdrawal Hypertension
- is high blood pressure, which is a
symptom of disease in the blood vessels leading away from the heart.
Hypertension is known as the “silent killer”. The symptoms are usually not
obvious, however it can lead to damage to the heart, brain, kidneys and eye, and
even to stroke and kidney failure. Treatment includes dietary and lifestyle
changes.
Cymbalta
withdrawal Bradycardia
-
The heart rate is slowed from 72 beats per minute,
which is normal, to below 60 beats per minute in an adult.
Cymbalta
withdrawal Tachycardia
- The heart rate is speeded up to
above 100 beats per minute in an adult. Normal adult heart rate is 72 beats per
minute.
Cymbalta
withdrawal ECG Abnormal
-
A test
called an electrocardiogram (ECG) that records the activity of the heart. It
measures heartbeats as will as the position and size of the heart’s four
chambers. It also measures if there is damage to the heart and the effects of
drugs or mechanical devices like a pacemaker on the heart. When the test is
abnormal this means that one or more of the following are present: heart
disease, defects, beating too fast or too slow, disease of the blood vessels
leading from the heart or of the heart valves, and/or a past or about to occur
heart attack.
Cymbalta
withdrawal Flushing
- The skin all over the body turns red.
Cymbalta withdrawal Varicose Vein - Unusually swollen veins
near the surface of the skin that sometimes appear twisted and knotted, but
always enlarged. They are called hemorrhoids when they appear around the
rectum. The cause is attributed to hereditary weakness in the veins aggravated
by obesity, pregnancy, pressure from standing, aging, etc. Severe cases may
develop swelling in the legs, ankles and feet, eczema and/or ulcers in the
affected areas.
Cymbalta
withdrawal
Gastrointestinal
(Involving
the stomach and the intestines)
Cymbalta withdrawal Abdominal Cramp/Pain
-
Sudden, severe, uncontrollable and painful shortening and
thickening of the muscles in the belly. The belly includes the stomach as well
as the intestines, liver, kidneys, pancreas, spleen, gall bladder, and urinary
bladder.
Cymbalta withdrawal Belching
- Noisy release of gas from the stomach through the mouth; a burp.
Cymbalta
withdrawal Bloating
- Swelling of the belly caused by excessive intestinal gas.
Cymbalta withdrawal Constipation
-
Difficulty in having a bowel movement where the material in the bowels is
hard due to a lack of exercise, fluid intake, and roughage in the diet, or due
to certain drugs.
Cymbalta withdrawal Diarrhea - Unusually frequent and excessive, runny bowel movements that may
result in severe dehydration and shock.
Cymbalta
withdrawal Dyspepsia - Indigestion. This is the discomfort you experience after eating. It
can be heartburn, gas, nausea, a bellyache or bloating.
Cymbalta withdrawal Flatulence
- More gas than normal in the digestive organs.
Cymbalta withdrawal Gagging
- Involuntary choking and/or involuntary throwing up.
Cymbalta withdrawal Gastritis
- A severe irritation of the mucus lining of the stomach either short in
duration or lasting for a long period of time.
Cymbalta withdrawal Gastroenteritis
-
A condition where the membranes
of the stomach and intestines are irritated.
Cymbalta
withdrawal Gastroesophageal
Reflux - A
continuous state where stomach juices flow back into the throat causing acid
indigestion and heartburn and possibly injury to the throat.
Cymbalta
withdrawal Heartburn
- A burning pain in the area of the breastbone caused by stomach juices flowing
back up into the throat.
Cymbalta withdrawal Hemorrhoids
- Small rounded
purplish swollen veins that either bleed, itch or are painful and appear around
the anus.
Cymbalta withdrawal Increased Stool frequency
-
Diarrhea.
Cymbalta
withdrawal Indigestion
- Unable to properly consume and absorb food in the digestive tract causing
constipation, nausea, stomach ache, gas, swollen belly, pain and general
discomfort or sickness.
Cymbalta withdrawal Nausea - Stomach irritation with a queasy sensation similar to
motion sickness and a feeling that one is going to vomit.
Cymbalta
withdrawal Polyposis Gastric
- Tumors that grow on stems in the lining of the stomach, which usually become
cancerous.
Cymbalta withdrawal Swallowing Difficulty
- A feeling that food is stuck in the throat or upper chest area and won’t go
down, making it difficult to swallow.
Cymbalta withdrawal Toothache
- Pain in a tooth above and below the gum line.
Cymbalta withdrawal Vomiting
- Involuntarily throwing up the contents of the stomach and usually getting a
nauseated, sick feeling just prior to doing so.
Cymbalta
withdrawal
General
Cymbalta withdrawal Allergy
-
The extreme
sensitivity of body tissues triggered by substances in the air, drugs, or foods
causing a reaction like sneezing, itching, asthma, hay fever, skin rashes,
nausea and/or vomiting.
Cymbalta withdrawal Anaphylaxis
- A violent, sudden, and severe drop
in blood pressure caused by a re-exposure to a foreign protein or a second
dosage of a drug that may be fatal unless emergency treatment is given right
away.
Cymbalta
withdrawal Asthenia
-
A physically
weak condition.
Cymbalta
withdrawal Chest Pains
-
Severe discomfort in the chest caused by not enough oxygen going to the heart
because of narrowing of the blood vessels or spasms.
Cymbalta
withdrawal Chills
-
Appearing
pale while cold and shivering; sometimes with a fever.
Cymbalta withdrawal Edema of
Extremities
-
Abnormal
swelling of the body’s tissue caused by the collection of fluid.
Cymbalta
withdrawal Fall
- To suddenly lose your normal
standing upright position as if you were shot.
Cymbalta
withdrawal Fatigue
- Loss of normal strength so as to
not be able to do the usual physical and mental activities.
Cymbalta
withdrawal Fever
- Abnormally high body temperature,
the normal being 98 degrees Fahrenheit or 37 degrees Centigrade in humans, which
is a symptom of disease or disorder in the body. The body is affected by
feeling hot, chilled, sweaty, weak and exhausted. If the fever goes too high,
death can result.
Cymbalta
withdrawal Hot Flashes
-
Brief,
abnormal enlargement of the blood vessels that causes a sudden heat sensation
over the entire body. Women in menopause will sometimes experience this.
Cymbalta
withdrawal Influenza-like
Symptoms
-
Demonstrating irritation of the respiratory tract (organs of breathing) such as
a cold, sudden fever, aches and pains, as well as feeling weak and seeking bed
rest, which is similar to having the flu.
Cymbalta
withdrawal Leg Pain
- A
hurtful sensation in the legs that is caused by excessive stimulation of the
nerve endings in the legs and results in extreme discomfort.
Cymbalta withdrawal Malaise
-
The somewhat
unclear feeling of discomfort you get when you start to feel sick.
Cymbalta
withdrawal Pain in Limb
-
Sudden, sharp and uncontrolled leg discomfort.
Cymbalta
withdrawal Syncope
-
A short
period of light headedness or unconsciousness (black-out) also know as fainting
caused by lack of oxygen to the brain because of an interruption in blood
flowing to the brain.
Cymbalta withdrawal Tightness of
Chest -
Mild or sharp discomfort, tightness
or pressure in the chest area (anywhere between the throat and belly). The
causes can be mild or seriously life-threatening because they include the heart,
lungs and surrounding muscles.
Cymbalta withdrawal
Hemic and Lymphatic Disorders
(Involving
the blood and the clear fluids in the tissues that contain white blood cells)
Cymbalta
withdrawal Bruise
- Damage to the skin resulting in a
purple-green-yellow skin coloration that’s caused by breaking the blood vessels
in the area without breaking the surface of the skin.
Cymbalta
withdrawal Anemia
-
A condition
where the blood is no longer carrying enough oxygen, so the person looks pale
and easily gets dizzy, weak and tired. More severely, a person can end up with
an abnormal heart, as well as breathing and digestive difficulties. The causes
of anemia are not enough protein in the red blood cells, or missing and
chemically destroyed red blood cells, as well as diseased or destroyed bone
marrow.
Cymbalta
withdrawal Nosebleed
- Blood lost from the part of the
face that has the organs of smell and is where the body takes in oxygen.
Cymbalta
withdrawal Hematoma
- Broken blood vessels that cause a
swelling in an area on the body.
Cymbalta
withdrawal Lymphadenopathy
Cervical
-
The lymph
nodes in the neck, which are part of the body’s immune system get swollen and
enlarge by reacting to the presence of a drug. The swelling is the result of
the white blood cells multiplying in order to fight the invasion of the drug.
Cymbalta withdrawal
Metabolic and Nutritional Disorders
(Energy
and health)
Cymbalta withdrawal Arthralgia
-
Sudden sharp
nerve pain in one or more joints.
Cymbalta withdrawal Arthropathy
- Having joint disease or abnormal
joints.
Cymbalta withdrawal Arthritis
-
Painfully inflamed and swollen joints. The reddened
and swollen condition is brought on by a serious injury or shock to the body
either from physical or emotional causes.
Cymbalta withdrawal Back Discomfort
- Severe physical distress in the area from the neck to the pelvis along the
backbone.
Cymbalta withdrawal Bilirubin Increased
- Bilirubin is a waste product of the breakdown
of old blood cells. Bilirubin is sent to the liver to be made water-soluble so
it can be eliminated from the body through emptying the bladder. A drug can
interfere with or damage this normal liver function creating liver disease.
Cymbalta withdrawal Decreased Weight
- Uncontrolled and measured loss of heaviness or weight.
Cymbalta withdrawal Gout
- A severe arthritis condition that is caused by the dumping of a waste product
called uric acid in the tissues and joints. It can become worse and cause the
body to develop a deformity after going through stages of pain, inflammation,
severe tenderness, and stiffness.
Cymbalta withdrawal Hepatic Enzymes Increased - An increase in the amount of paired liver proteins that
regulate liver processes causing a condition where the liver functions
abnormally.
Cymbalta withdrawal
Hypercholesterolemia
- Too much cholesterol in the blood cells.
Cymbalta withdrawal Hyperglycemia
- An unhealthy amount of sugar in the blood.
Cymbalta withdrawal Increased Weight - A concentration and storage of fat in the body
accumulating over a period of time caused by unhealthy eating patterns, that can
predispose the body to many disorders and diseases.
Cymbalta withdrawal Jaw Pain - The pain due to irritation and swelling of the nerves associated with
the mouth area where it opens and closes just in front of the ear. Some of the
symptoms are pain when chewing, head aches, losing your balance, stuffy ears or
ringing in the ears, and teeth grinding.
Cymbalta withdrawal Jaw Stiffness
- The result of squeezing and grinding the teeth while asleep that can cause
your teeth to deteriorate as well as the muscles and joints of the jaw.
Cymbalta withdrawal Joint Stiffness
- A loss of free motion and easy flexibility where any
two bones come together.
Cymbalta withdrawal Muscle Cramp - When muscles contract uncontrollably without warning and do not
relax. The muscles of any of the body’s organs can cramp.
Cymbalta withdrawal Muscle Stiffness
- Tightening of muscles making it difficult to bend.
Cymbalta withdrawal Muscle Weakness
- Loss of physical strength.
Cymbalta withdrawal Myalgia - A general widespread pain and tenderness of the muscles.
Cymbalta
withdrawal Thirst
- A strong,
unnatural craving for moisture/water in the mouth and throat.
Cymbalta withdrawal
Nervous System (Sensory channels)
Cymbalta
withdrawal Carpal Tunnel
Syndrome - A pinched
nerve in the wrist that causes pain, tingling, and numbing.
Cymbalta withdrawal Coordination Abnormal - A lack of normal, harmonious interaction of the parts of
the body when it is in motion.
Cymbalta withdrawal Dizziness - Losing one’s balance while feeling unsteady and lightheaded which may
lead to fainting.
Cymbalta withdrawal Disequilibrium
- Lack of mental and emotional balance.
Cymbalta withdrawal Faintness - A temporary condition where one is likely to go
unconscious and fall.
Cymbalta withdrawal Headache - A sharp or dull persistent pain in the head
Cymbalta withdrawal Hyperreflexia - A not normal and involuntary increased response in the
tissues connecting the bones to the muscles.
Cymbalta withdrawal Light-headed
Feeling –
Uncontrolled and usually brief loss of consciousness caused by lack of oxygen to
the brain.
Cymbalta withdrawal Migraine
- Reoccurring severe head pain usually with nausea, vomiting, dizziness, flashes
or spots before the eyes, and ringing in the ears
Cymbalta withdrawal Muscle Contractions Involuntary
- Spontaneous and uncontrollable tightening reaction of the muscles caused by
electrical impulses from the nervous system.
Cymbalta withdrawal Muscular Tone Increased - Uncontrolled and exaggeration muscle tension. Muscles are
normally partially tensed and this is what gives us muscle tone.
Cymbalta withdrawal Paresthesia - Burning, prickly, itchy, or tingling skin with no obvious or
understood physical cause.
Cymbalta withdrawal Restless Legs
- A need to move the legs without any apparent reason. Sometimes there is pain,
twitching, jerking, cramping, burning, or a creepy-crawly sensation associated
with the movements. It worsens when a person is inactive and can interrupt
one’s sleep so one feels the need to move to gain some relief.
Cymbalta withdrawal Shaking
- Uncontrolled quivering and trembling as if one is cold and chilled.
Cymbalta withdrawal Sluggishness
- Lack of alertness and energy, as well as being slow to respond or perform in
life.
Cymbalta withdrawal Tics - A contraction of a muscle causing a repeated movement not
under the control of the person usually on the face or limbs.
Cymbalta withdrawal Tremor
- A nervous and involuntary vibrating or quivering of the body.
Cymbalta withdrawal Twitching - Sharp, jerky and spastic motion sometimes with a
sharp sudden pain.
Cymbalta withdrawal Vertigo
- A sensation of dizziness with disorientation and confusion.
Cymbalta
withdrawal Psychiatric Disorders (Mental and emotional)
Cymbalta withdrawal Aggravated Nervousness
- A progressively worsening, irritated and troubled state of mind.
Cymbalta
withdrawal Agitation
- Suddenly violent and forceful, emotionally disturbed state of mind.
Cymbalta withdrawal Amnesia - Long term or short term, partial or full memory loss created by
emotional or physical shock, severe illness, or a blow to the head where the
person was caused pain and became unconsciousness.
Cymbalta
withdrawal Anxiety Attack
- Sudden and intense feelings of fear, terror, and dread physically creating
shortness of breath, sweating, trembling and heart palpitations.
Cymbalta withdrawal Apathy
- Complete lack of concern or interest for things that ordinarily would be
regarded as important or would normally cause concern.
Cymbalta
withdrawal Appetite
Decreased - Having a
lack of appetite despite the ordinary caloric demands of living with a resulting
unintentional loss of weight.
Cymbalta
withdrawal Appetite
Increased - An
unusual hunger causing one to overeat.
Cymbalta
withdrawal Auditory
Hallucination -
Hearing things without the voices or noises being present.
Cymbalta
withdrawal Bruxism
-
Grinding and clenching of teeth while sleeping.
Cymbalta withdrawal Carbohydrate
Craving - A drive
and craving to eat foods rich in sugar and starches (sweets, snacks and junk
foods) that intensifies as the diet becomes more and more unbalanced due to the
unbalancing of the proper nutritional requirements of the body.
Cymbalta withdrawal Concentration Impaired
- Unable to easily focus your attention for long periods of time.
Cymbalta
withdrawal Confusion
- Not able to think clearly and understand in order to make a logical decision.
Cymbalta
withdrawal Crying Abnormal
- Unusual and not normal fits of weeping for short or long periods of time for
no apparent reason.
Cymbalta withdrawal Depersonalization
- A condition where one has lost a normal sense of personal identity.
Cymbalta
withdrawal Depression
- A hopeless feeling of failure, loss and sadness that can deteriorate into
thoughts of death.
Cymbalta
withdrawal Disorientation
- A loss of sense of direction, place, time or surroundings as well as mental
confusion on personal identity.
Cymbalta
withdrawal Dreaming Abnormal
- Dreaming that leaves a very clear, detailed picture and impression when awake
that can last for a long period of time and sometimes be unpleasant.
Cymbalta
withdrawal Emotional
Lability
- Suddenly breaking out
in laughter or crying or doing both without being able to control the outburst
of emotion. These episodes are unstable as they are caused by things that
normally would not have this effect on an individual.
Cymbalta withdrawal Excitability - Uncontrollably responding to stimuli.
Cymbalta withdrawal Feeling Unreal - The awareness that one has an undesirable emotion like
fear but can’t seem to shake off the irrational feeling. For example, feeling
like one is going crazy but rationally knowing that it is not true. The quality
of this side effect resembles being in a bad dream and not being able to wake
up.
Cymbalta
withdrawal Forgetfulness
- Unable to remember what one ordinarily would remember.
Cymbalta
withdrawal Insomnia
- Sleeplessness caused by physical stress, mental stress or stimulants such as
coffee or medications; it is a condition of being abnormally awake when one
would ordinarily be able to fall and remain asleep.
Cymbalta
withdrawal Irritability
- Abnormally annoyed in response to a stimulus.
Cymbalta withdrawal Jitteriness - Nervous fidgeting without an apparent cause.
Cymbalta
withdrawal Lethargy
- Mental and physical sluggishness and apathy that can deteriorate into an
unconscious state resembling deep sleep. A numbed state of mind.
Cymbalta
withdrawal Libido Decreased
- An abnormal loss of sexual energy or desire.
Cymbalta withdrawal Panic Reaction
- A sudden, overpowering, chaotic and confused mental state of terror resulting
in being doubt ridden often accompanied with hyperventilation, and extreme
anxiety.
Cymbalta
withdrawal Restlessness
Aggravated - A
constantly worsening troubled state of mind characterized by the person being
increasingly nervous, unable to relax, and easily angered.
Cymbalta
withdrawal Somnolence - Feeling sleepy all the time or having a condition of
semi-consciousness.
Cymbalta
withdrawal Suicide Attempt
- An unsuccessful deliberate attack on one’s own life with the intention of
ending it.
Cymbalta
withdrawal Suicidal Tendency
- Most likely will attempt to kill oneself.
Cymbalta withdrawal Tremulousness
Nervous - Very
jumpy, shaky, and uneasy while feeling fearful and timid. The condition is
characterized by thoughts of dreading the future, involuntary quivering,
trembling, and feeling distressed and suddenly upset.
Cymbalta withdrawal Yawning - involuntary opening of the mouth with deep inhalation of
air.
Cymbalta
withdrawal
Reproductive Disorder Female
Cymbalta
withdrawal Breast Neoplasm
-
A tumor or cancer, of either of the two milk-secreting
organs on the chest of a woman.
Cymbalta
withdrawal Menorrhagia
- Abnormally heavy menstrual period or a
menstrual flow that has continued for an unusually long period of time.
Cymbalta
withdrawal Menstrual Cramps
- Painful, involuntary uterus contractions that women experience around the time
of their menstrual period, sometimes causing pain in the lower back and thighs.
Cymbalta
withdrawal Menstrual
Disorder - A disturbance or derangement in the normal function of a woman’s
menstrual period.
Cymbalta
withdrawal Pelvic
Inflammation - The reaction of the body to infectious, allergic, or chemical
irritation, which in turn causes tissue irritation, injury, or bacterial
infection characterized by pain, redness, swelling, and sometimes loss of
function. The reaction usually begins in the uterus and spreads to the
fallopian tubes, ovaries, and other areas
in the hipbone region of the body.
Cymbalta
withdrawal Premenstrual
Syndrome - Various physical and mental symptoms commonly experienced by women of
childbearing age usually 2 to 7 days before the start of their monthly period.
There are over 150 symptoms including eating binges, behavioral changes,
moodiness, irritability, fatigue, fluid retention, breast tenderness, headaches,
bloating, anxiety, and depression. The symptoms cease shortly after the period
begins, and disappear with menopause.
Cymbalta
withdrawal Spotting Between
Menses - Abnormal bleeding between periods. Unusual spotting
between menstrual cycles.
Cymbalta
withdrawal
RESPIRATORY SYSTEM
(Organs involved in breathing)
Cymbalta
withdrawal Asthma
- A disease of the breathing system initiated by and allergic reaction
or a chemical with repeated attacks of coughing, sticky mucus, wheezing,
shortness of breath, and a tight feeling in the chest. The disease can reach a
state where it stops a person from exhaling, leading to unconsciousness and
death.
Cymbalta
withdrawal Breath Shortness
-
Unnatural breathing using a lot off effort resulting in not enough air taken in
by the body.
Cymbalta
withdrawal Bronchitis
- Inflammation of the two main
breathing tubes leading from the windpipe to the lungs. The disease is marked
with coughing, a low-grade fever, chest pains, and hoarseness, caused by an
allergic reaction.
Cymbalta
withdrawal Coughing
- A cough is the response to an
irritation, such as mucus, that causes the muscles controlling the breathing
process to expel air from the lungs suddenly and noisily to keep the air
passages free from the irritating material.
Cymbalta
withdrawal Laryngitis
- Inflammation of the voice box
characterized by hoarseness, sore throat, and coughing. It can be cause by
straining the voice or exposure to infectious, allergic or chemical irritation.
Cymbalta
withdrawal Nasal Congestion
- The
presence of an abnormal amount of fluid in the nose.
Cymbalta
withdrawal Pneumonia
Tracheitis - Bacterial infection of the air passageways and lungs that causes
redness, swelling and pain in the windpipe. Other symptoms are high fever,
chills, pain in the chest, difficulty in breathing, and coughing with mucus
discharge.
Cymbalta
withdrawal Rhinitis
- Chemical irritation causing pain,
redness and swelling in the mucus membranes of the nose.
Cymbalta
withdrawal Sinus Congestion
- The
mucus-lined areas of the bones in the face that are thought to help warm and
moisten air to the nose. These areas become clogged with excess fluid or
infected.
Cymbalta
withdrawal Sinus Headache
- The
abnormal amount of fluid in the hollows of the face bone area especially around
the nose. This excess fluid creates pressure, causing pain in the head.
Cymbalta
withdrawal Sinusitis
- The body reacting to chemical
irritation causing redness, swelling and pain in the area of the hollows in the
facial bones especially around the nose.
Cymbalta
withdrawal SKELETAL
Cymbalta withdrawal Neck/Shoulder Pain
- Hurtful sensations
of the nerve endings caused by damage to the tissues in the neck and shoulder
signaling danger of disease.
Cymbalta
withdrawal
SKIN and APPENDAGES DISORDERS (Skin, legs and arms)
Cymbalta
withdrawal Acne
- Eruptions of the oils glands of the
skin, especially on the face, marked by pimples, blackheads, whiteheads, bumps,
and more severely, by cysts and scarring.
Cymbalta withdrawal Alopecia -
The loss of hair or baldness.
Cymbalta
withdrawal Eczema
- A severe or continuing skin disease
marked by redness, crusting and scaling with watery blisters and itching. It is
often difficult to treat and will sometimes go away only to reappear again.
Cymbalta
withdrawal Dermatitis
- Generally irritated skin that can
be caused by any of a number of irritating things such as parasites, fungus,
bacteria, or foreign substances
causing an allergic reaction. It is a general inflammation of the skin.
Cymbalta
withdrawal Dry Lips
- The
lack of normal moisture in the fleshy folds that surround the mouth.
Cymbalta withdrawal Dry Skin - The lack of normal moisture/oils in the
surface layer of the body. The skin is the body’s largest organ.
Cymbalta withdrawal Folliculitis
-
Inflammation of a follicle (small body sac) especially a hair follicle. A hair
follicle contains the root of a hair.
Cymbalta withdrawal Furunculosis - Skin boils that show up repeatedly.
Cymbalta withdrawal Lipoma - A tumor of mostly fat cells that is not health
endangering.
Cymbalta withdrawal Pruritus
- Extreme itching of often-undamaged skin.
Cymbalta withdrawal Rash - A skin eruption or discoloration that may or may not be
itching, tingling, burning, or painful. It may be caused by an allergy, an skin
irritation, a skin disease.
Cymbalta withdrawal Skin Nodule - A bulge, knob, swelling or outgrowth in the skin
that is a mass of tissue or cells.
Cymbalta withdrawal
SPECIAL SENSES
Cymbalta withdrawal Conjunctivitis
- Infection of the membrane that covers the eyeball and lines the eyelid, caused
by a virus, allergic reaction, or an irritating chemical. It is characterized
by redness, a discharge of fluid and itching.
Cymbalta withdrawal Dry Eyes - Not enough moisture in the eyes.
Cymbalta withdrawal Earache - Pain in the ear.
Cymbalta withdrawal Eye Infection
- The invasion of the eye tissue by a bacteria, virus, fungus, etc, causing
damage to the tissue, with toxicity. Infection spreading in the body progresses
into disease.
Cymbalta withdrawal Eye Irritation
- An inflammation of the eye.
Cymbalta withdrawal Metallic Taste
- A range of taste impairment from distorted taste to a complete loss of taste.
Cymbalta withdrawal Pupils Dilated
- Abnormal expansion of the blace circular opening in the center of the eye.
Cymbalta withdrawal Taste alteration
- Abnormal flavor detection in food.
Cymbalta withdrawal Tinnitus - A buzzing, ringing, or whistling sound in one or
both ears occurring from the internal use of certain drugs.
Cymbalta withdrawal Vision Abnormal
- Normal images are seen differently by the viewer.
Cymbalta withdrawal Vision Blurred
- Eyesight is dim or indistinct and hazy in outline or appearance.
Cymbalta withdrawal Visual Disturbance
- Eyesight is interfered with or interrupted. Some disturbances are light
sensitivity and the inability to easily distinguish colors.
Cymbalta withdrawal
URINARY SYSTEM DISORDER
Cymbalta withdrawal Blood in Urine
-
Blood is present when one empties liquid waste product of the kidneys through
the bladder by urinating in the toilet turning the water pink to bright red. Or
you could see pots of blood in the water after urinating.
Cymbalta withdrawal Dysuria
- Difficult or painful urination.
Cymbalta withdrawal Kidney Stone
- Small hard masses of salt deposits that the kidney forms.
Cymbalta withdrawal Urinary Frequency - Having to urinate more often than usual or between unusually short
time periods.
Cymbalta withdrawal Urinary Tract
Infection - An invasion of bacteria, viruses, fungi, etc., of the
system in the body that starts with the kidneys and eliminates urine from the
body. If the invasion goes unchecked it can injure tissue and progress into
disease.
Cymbalta withdrawal Urinary Urgency
- A sudden compelling urge to urinate, accompanied by discomfort in the bladder.
Cymbalta withdrawal
UROGENITAL (Urinary tract and genital structures or functions)
Cymbalta withdrawal Anorgasmia
- Failure to experience an orgasm.
Cymbalta withdrawal Ejaculation
Disorder - Dysfunction of the discharge of semen during orgasm.
Cymbalta withdrawal Menstrual
Disorder - Dysfunction of the discharge during the monthly menstrual cycle.
Cymbalta withdrawal
Acute Renal
Failure - The kidneys
stop functioning properly to excrete wastes.
Cymbalta withdrawal
Angioedema
- Intensely itching and swelling welts on the skin called hives caused by an
allergic reaction to internal or external agents. The reaction is common to a
food or a drug. Chronic cases can last for a long period of time.
Cymbalta withdrawal Toxic Epidermal
Necrolysis - An abnormal condition where a large portion of skin
becomes intensely red and peels off like a second-degree burn. Often the
symptoms include blistering.
Cymbalta withdrawal Gastrointestinal
Hemorrhage - Stomach and intestinal excessive internal bleeding.
Cymbalta withdrawal Grand Mal
Seizures (or Convulsions)
- A recurring sudden violent and involuntary attack of muscle spasms with a loss
of consciousness.
Cymbalta withdrawal Neuroleptic Malignant Syndrome
- A life threatening, rare reaction to an anti-psychotic drug marked by fever,
muscular rigidity, changed mental status, and dysfunction of the autonomic
nervous system.
Cymbalta withdrawal Pancreatitis - Chemical irritation with redness, swelling, and
pain in the pancreas where digestive enzymes and hormones are secreted.
Cymbalta withdrawal QT Prolongation
- A very fast heart rhythm disturbance that is too fast for the heart to beat
effectively so the blood to the brain falls causing a sudden loss of
consciousness and may cause sudden cardiac death.
Cymbalta withdrawal Rhabdomyolysis
- The breakdown of muscle fibers that releases the fibers into the circulatory
system. Some of the fibers are poisonous to the kidney and frequently result in
kidney damage.
Cymbalta withdrawal Serotonin Syndrome
- A disorder brought on by excessive levels of serotonin caused by drugs and can
be fatal as death from this side effect can come very rapidly.
Cymbalta withdrawal Thrombocytopenia
- An abnormal decrease in the number of blood platelets in the circulatory
system. A decrease in platelets would cause a decrease in the ability of the
blood to clot when necessary.
Cymbalta withdrawal Torsades de Pointes -
Unusual rapid heart rhythm starting in the lower heart chambers. If the short
bursts of rapid heart rhythm continue for a prolonged period it can degenerate
into a more rapid rhythm and can be fatal.
Cymbalta Clinical Trials
High-dose duloxetine for treatment-resistant
obsessive-compulsive disorder: a case report with sustained full remission.
Yeh YW, Chen CH, Kuo SC, Wang SC, Chen CK, Feng HM.
Clin Neuropharmacol. 2009 May-Jun;32(3):174-6. No
abstract available.
PMID: 19483491 [PubMed - in process]
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[No authors listed]
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[No authors listed]
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Reeves RR, Brister JC.
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Volpe FM.
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M, Barbui C.
Lancet. 2009 Feb 28;373(9665):746-58. Review.
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[Is medical therapy useful in the management of
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Oelke M, Seidler M, Uckert S, Gabuev A.
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Ferro FM.
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Munro G.
Eur J Pharmacol. 2009 Mar 1;605(1-3):95-102. Epub
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Semin Arthritis Rheum. 2009 Jan 17. [Epub ahead of
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Wasan AD, Ossanna MJ, Raskin J, Wernicke JF,
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Llorca PM, Bodkin JA, Spann M, Ball SG, Russell JM,
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J Clin Psychopharmacol. 2009 Feb;29(1):96-7. No
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[Chronic pain and depression]
Voznesenskaia TG.
Zh Nevrol Psikhiatr Im S S Korsakova.
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Effects of selective serotonin reuptake and dual
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Herrera-Guzmán I, Gudayol-Ferré E, Herrera-Guzmán
D, Guŕrdia-Olmos J, Hinojosa-Calvo E, Herrera-Abarca JE.
J Psychiatr Res. 2009 Jun;43(9):855-63. Epub 2009
Jan 6.
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Fibromyalgia coverage uneven despite recent drug
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Sipkoff M.
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Melo LP, Nogueira AM, Lanças FM, Queiroz ME.
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Perlis RH, Fijal B, Adams DH, Sutton VK, Trivedi
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Tomillero A, Moral MA.
Methods Find Exp Clin Pharmacol. 2008
Oct;30(8):643-72.
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Preskorn SH, Nichols AI, Paul J, Patroneva AL,
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Arnold LM, Meyers AL, Sunderajan P, Montano CB,
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Walton SM, Schumock GT, Lee KV, Alexander GC,
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Molteni R, Calabrese F, Cattaneo A, Mancini M,
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Qaseem A, Snow V, Denberg TD, Forciea MA, Owens DK;
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Ann Intern Med. 2008 Nov 18;149(10):725-33. Erratum
in: Ann Intern Med. 2009 Jan 20;150(2):148.
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10.2165/0019053-200826120-00007.
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Antidepressant-induced sweating alleviated by
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Lu BY, Cullen CE, Eide CE, Williams CC, Apfeldorf
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Boomershine CS.
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5.
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Holman AJ.
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[Combination of Dialectical Behavioral Therapy (DBT)
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German.
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Kajdasz DK.
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print]
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Multiplicative interactions to enhance gabapentin to
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Hayashida K, Eisenach JC.
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Patroneva A, Connolly SM, Fatato P, Pedersen R,
Jiang Q, Paul J, Guico-Pabia C, Isler JA, Burczynski ME, Nichols AI.
Drug Metab Dispos. 2008 Dec;36(12):2484-91. Epub
2008 Sep 22.
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Antidepressants targeting the serotonin reuptake
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Apparsundaram S, Stockdale DJ, Henningsen RA, Milla
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2008 Sep 18.
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Menezes HS, Bueno BB, Ciulla L, Schuh A, Luz Fde F,
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Acta Cir Bras. 2008 Sep-Oct;23(5):447-50.
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Lin CC.
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[No authors listed]
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Neurochem Res. 2009 Mar;34(3):542-55. Epub 2008 Aug
27.
PMID: 18751896 [PubMed - indexed for
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Stevens DL.
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Dekeyne A, Millan MJ.
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Perahia DG, Quail D, Desaiah D, Montejo AL,
Schatzberg AF.
J Psychiatr Res. 2009 Feb;43(5):512-8. Epub 2008
Aug 15.
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MEDLINE]
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Basal and stress-induced modulation of
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Molteni R, Calabrese F, Mancini M, Racagni G, Riva
MA.
Psychopharmacology (Berl). 2008 Dec;201(2):285-92.
Epub 2008 Aug 14.
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MEDLINE]
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Wells KA, Losin WG.
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Spina E, Santoro V, D'Arrigo C.
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Strombom I, Wernicke JF, Seeger J, D'Souza DN,
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Wernicke J, Pangallo B, Wang F, Murray I, Henck JW,
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Fibromyalgia syndrome: a relevant recent
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Perrot S.
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Griffith JM, Hasley JP, Severn DG.
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Bergman BR, Reynolds HR, Skolnick AH, Castillo D.
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MEDLINE]
Duloxetine for painful diabetic neuropathy and
fibromyalgia pain: systematic review of randomised trials.
Sultan A, Gaskell H, Derry S, Moore RA.
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MEDLINE]
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Are SNRIs More Effective than SSRIs? A Review of the
Current State of the Controversy.
Thase ME.
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The relationship between functional outcomes and the
treatment of anxious and painful somatic symptoms in patients with generalized
anxiety disorder.
Sheehan DV, Meyers AL, Prakash A, Robinson MJ,
Swindle RW, Russell JM, Mallinckrodt CH.
Curr Med Res Opin. 2008 Sep;24(9):2457-66. Epub
2008 Jul 24.
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MEDLINE]
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Duloxetine (cymbalta) for fibromyalgia.
[No authors listed]
Med Lett Drugs Ther. 2008 Jul 28;50(1291):57-8. No
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MEDLINE]
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Postgrad Med. 2008 Jul;120(2):111-8. Review.
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MEDLINE]
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Duloxetine: a new psychopharmacologic treatment
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Pae CU, Masand P.
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The influence of smoking on the serum level of
duloxetine.
Fric M, Pfuhlmann B, Laux G, Riederer P, Distler G,
Artmann S, Wohlschläger M, Liebmann M, Deckert J.
Pharmacopsychiatry. 2008 Jul;41(4):151-5.
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MEDLINE]
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Kornstein SG, Dunner DL, Meyers AL, Whitmyer VG,
Mallinckrodt CH, Wohlreich MM, Detke MJ, Hollandbeck MS, Greist JH.
J Clin Psychiatry. 2008 Jul 15:e1-e10. [Epub ahead
of print]
PMID: 18642978 [PubMed - as supplied
by publisher]
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Volpe FM.
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PMID: 18642977 [PubMed - as supplied
by publisher]
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Allgulander C, Nutt D, Detke M, Erickson J, Spann
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J Psychopharmacol. 2008 Jun;22(4):417-25.
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MEDLINE]
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Nutt D, Allgulander C, Lecrubier Y, Peters T,
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Wine and drug evaluations: lessons on making
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Allgulander C, Nutt DJ.
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PMID: 18635714 [PubMed - indexed for
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Shock-like sensations associated with duloxetine
discontinuation.
Pitchot W, Ansseau M.
Ann Clin Psychiatry. 2008 Jul-Sep;20(3):175. No
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Fava M, Wiltse C, Walker D, Brecht S, Chen A,
Perahia D.
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Hartford JT, Endicott J, Kornstein SG, Allgulander
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Prim Care Companion J Clin Psychiatry.
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Non-fatal overdose of duloxetine in combination with
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Menchetti M, Ferrari Gozzi B, Addolorata Saracino
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World J Biol Psychiatry. 2008 Jun 2:1-5. [Epub
ahead of print]
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Englisch S, Knopf U, Scharnholz B, Kuwilsky A,
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print]
PMID: 18583440 [PubMed - as supplied
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Dissociable effects of acute antidepressant drug
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volunteers.
Harmer CJ, Heinzen J, O'Sullivan U, Ayres RA, Cowen
PJ.
Psychopharmacology (Berl). 2008 Sep;199(4):495-502.
Epub 2008 Jun 25.
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Peritogiannis V, Antoniou K, Mouka V, Mavreas V,
Hyphantis TN.
J Psychopharmacol. 2008 Jun 18. [Epub ahead of
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PMID: 18562441 [PubMed - as supplied
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Effect of antidepressants on melatonin metabolite in
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Carvalho L, Gorenstein C, Moreno R, Pariante C,
Markus R.
J Psychopharmacol. 2009 May;23(3):315-321. Epub
2008 Jun 18.
PMID: 18562432 [PubMed - as supplied
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Severe and symptomatic hyponatremia following
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Müssig K, Mörike K, Häring H.
J Psychopharmacol. 2009 May;23(3):338-9. Epub 2008
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PMID: 18562431 [PubMed - in process]
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Moral MA, Tomillero A.
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trial.
Davidson JR, Wittchen HU, Llorca PM, Erickson J,
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Eur Neuropsychopharmacol. 2008 Sep;18(9):673-81.
Epub 2008 Jun 17.
PMID: 18559291 [PubMed - indexed for
MEDLINE]
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[Escitalopram versus serotonin reuptake inhibitors]
Millet B.
Encephale. 2008 Jun;34(3):280-3. Epub 2008 Jun 4.
French.
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incontinence.
Schagen van Leeuwen JH, Lange RR, Jonasson AF, Chen
WJ, Viktrup L.
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10.
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Colucci VJ, Berry BD.
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Free article in PMC
What
is Cymbalta?
Cymbalta is a new antidepressant manufactured by Eli Lilly and Company, the
approval of which Has finally been granted by the U.S. Food and Drug Administration.
This happens on the heals of one suicide of a 19 year-old, in perfect health, no
mental disorder, hanging herself at the Eli Lilly complex, after taking
Cymbalta. This is approved when pressure is being put on all of the
pharmaceutical firs to fully disclose their clinical trials.
Did the FDA feel a little
pressure from the current Administration? If you have an adverse event or commit
suicide while taking Cymbalta, odds are the current Administration will pay for
and support Eli Lilly to beat you in court. The current administration admits this.
August 11, 2004 - The FDA
states Cymbalta had nothing to do with the hanging death at the Eli Lilly
facility. Let's look at the known data here:
-
You have a healthy 19
year old female as part of the Cymbalta clinical trials.
-
She is given a much
higher dosage then recommended.
-
Part of her trial was
to quit the Cymbalta quickly
-
She hangs herself
-
She has no mental
illness
-
She was in perfect
physical health per Eli Lilly
-
She was in the trial to
earn money for college
-
The current administration
will supply Eli Lilly with their attorneys to help fight consumer lawsuits
because "the FDA is never wrong"
-
The FDA uses their own
lead attorney to help Eli Lilly and others fight consumer lawsuits because
the FDA is never wrong.
-
The current
administration is full of Eli Lilly past executives.
-
You would think if the
FDA clears Cymbalta as the cause of death, they would disclose why or what
the reason was.
-
Amazing, the FDA
statement of Cymbalta having nothing to do with this suicide, would come
within 1 week of Cymbalta being approved by the FDA and within 3 weeks of
the massive launch of Cymbalta by Eli Lilly. Eli Lilly will have more drug
reps hit the streets to visit physicians then with any other drug of theirs
in the past.
-
If Cymbalta fails, Eli
Lilly will suffer on Wall Street.
Eli Lilly is being sued again
after a SWAT captain commits suicide after only 3 days of Prozac use. Eli Lilly
has already settled 2 suits out of court for the same issue. Know what can
happen before you take these medications. There is a way to know.
Click
here for story. (Opens new browser)
August 4, 2004 - Now that Cymbalta is
approved by the FDA will Eli Lilly disclose all of their clinical trials? With a
high profile suicide occurring during the clinical trial, will the pressure be
enough on Eli Lilly? When a healthy volunteer, with no known mental illness or
physical problem commits suicide on Cymbalta, will Eli Lilly disclose all of the
facts?
Eli Lilly, I know you are on this Web Site daily,
especially when it comes up first on most search engines for your new
antidepressant Cymbalta, what are you going to do? Disclose all of the facts or not? If
you work with Eli Lilly and feel it is time for you to come clean and disclose
all you know about Cymbalta hidden information,
Click here
and send an e-mail.
Click here for Cymbalta Adverse
Reactions and more
What is
Cymbalta?
Cymbalta is a brand-name for a
drug called duloxetine. It is in a
class of drugs known as dual uptake inhibitors.
So what is a dual uptake inhibitor -- or an uptake
inhibitor, for that matter?
The way a neurotransmitter works is, it is passed along from one nerve to
another. A bit of it is sent out at
a time from one nerve to the next. After
a bit is sent out and received by the next nerve, any of the neurotransmitter
remaining between the nerves is taken back by the first nerve, a process called
reuptake.
A
reuptake inhibitor prevents this reuptake process from occurring, which means
that, when Cymbalta is active, certain neurotransmitters are transmitted in
steady streams from one nerve ending to the next, instead of being sent in bits
periodically, which they normally are. The
neurotransmitters affected by Cymbalta are known as serotonin and
norepinephrine. And now we can
explain what "dual uptake inhibitor" means -- it simply means a drug
that affects the reuptake of two neurotransmitters instead of one.
Back
to top of page
Does
Cymbalta cure depression?
Good
question. If depression has never
been proven to be caused by neurotransmitters (or the lack of them), that
question cannot obviously be answered conclusively.
Apparently,
Eli Lilly and Company knows this. According
to a recent news release from Eli Lilly regarding Cymbalta:
"Many experts believe treating the complete spectrum of
depression symptoms is intrinsic to a lasting recovery. As well, combined action through two key neurotransmitters - serotonin
and norepinephrine - may provide a more rapid and sustained clinical
effect."
Note the subtle uncertainties
in these statements, for there is absolutely no scientific proof behind them.
"Many experts believe treating the complete spectrum of
depression symptoms..." "...combined
action through two key neurotransmitters - serotonin and norepinephrine - may
provide..."
Translation:
They don't know how, why, or if their drug works.
This is evident in the numerous -- and serious -- side effects provided
by other antidepressants. Lilly's
press release did not even address side effects, but another of their releases
regarding Cymbalta's clinical trials revealed three of the exact same side
effects as other antidepressants: Dizziness,
anxiety, and nausea.
In that Cymbalta has the exact
same action as Wyeth's drug Effexor, one could assume the same side effects. (See "Precautions" section on Effexor
page). (Opens new
browser)
Back
to top of page
What
is Depression?
Depression is defined by the
Diagnostic and Statistical Manual of Mental Disorders (DSM), published by the
American Psychiatric Association, this way:
The essential feature of a
Major Depressive Episode is a period of at least 2 weeks during which there is
either depressed mood or the loss of interest or pleasure in nearly all
activities. In children and
adolescents, the mood may be irritable rather than sad.
The individual must also experience at least four additional symptoms
drawn from a list that includes major changes in appetite or weight, sleep, and
psychomotor [of or relating to movement or
muscular activity associated with mental processes] activity; decreased
energy; feelings of worthlessness or guilt; difficulty thinking, concentrating,
or making decisions; or recurrent thoughts of death or suicidal ideation, plans,
or attempts."
While these elements can
certainly be seen to exist and have been experienced by many, labeling
"depression" as an illness has been criticized by many as simply
labeling part of life itself as a physical "disease" which must be
"cured".
This could be debated
endlessly, however, and whole long texts have been written on the subject.
Depression as a state of mind certainly does exist, and can be
painful. The question to be
addressed here, though, is, does depression truly have a physical cause that can
be addressed with medication?
For the answer, let's go back
to the DSM. The only information
given there as to physical causes of depression is:
Neurotransmitters implicated
in the pathophysiology [study of the physical
effects of a disease] of a Major Depressive Episode include
norepinephrine, serotonin, acetylcholine
, dopamine, and gamma-aminobutryric
acid.
Back
to top of page
All right, what does all that
mean? Here's a simple explanation.
A neurotransmitter is a chemical that helps transmit nerve
impulses through the nervous system. There
are many different neurotransmitters used by the body.
What the DSM definition is saying is that, by some method, the
neurotransmitter chemicals known as norepinephrine,
serotonin, acetylcholine
, dopamine, and gamma-aminobutryric acid seemed to be
lower in some depressed people, or higher in non-depressed people.
Note carefully the use of the
word implicated in the DSM definition, however.
And therein is the first clue, for it has never been clinically proven
that depression is based in neurotransmitters.
We repeat: Never.
And believe it or not, there is not a doctor on Earth that will disagree
with that statement.
Which leads to the conclusion
that a physical cause for depression has never been isolated.
Why, then, is Eli Lilly and Company, Cymbalta's manufacturer, so
insistent that Cymbalta is a great treatment for depression?
For the answer to this, let's
turn to Eli Lilly and find out exactly what Cymbalta is, and how it works.
Should
You Take Cymbalta?
Back
to top of page
The answer is, of course, up
to you. Before you do, however,
become fully informed of the dangers from the manufacturer.
As yet the full list of side effects have not been published.
You should also be aware of a dangerous
metabolism issue that may affect you, and for which you should be
tested before you take such a drug.
CYMBALTA
(duloxetine hydrochloride)
Pharmacokinetics
CYMBALTA has an elimination half-life of about 12 hours
(range 8 to 17 hours) and its pharmacokinetics are dose proportional over the
therapeutic range. Steady-state plasma concentrations are typically achieved
after 3 days of dosing. Elimination of CYMBALTA is mainly through hepatic
metabolism involving two P450 isozymes, CYP2D6 and CYP1A2.
Absorption and Distribution – Orally administered
CYMBALTA is well absorbed. There is a median 2-hour lag until absorption begins
(T lag), with maximal plasma
concentrations C max) of CYMBALTA
occurring 6 hours post dose. Food does not affect the Cmax
of CYMBALTA, but delays the time to reach peak concentration from 6 to 10 hours
and it marginally decreases the extent of absorption (AUC) by about 10%. There
is a 3-hour delay in absorption and a one-third increase in apparent clearance
of CYMBALTA after an evening dose as compared to a morning dose.
The apparent volume of distribution averages about 1640
L. CYMBALTA is highly bound (>90%) to proteins in human plasma, binding
primarily to albumin and ą1-acid
glycoptrotein. Plasma protein binding of CYMBALTA is not affected by renal or
hepatic impairment.
Metabolism and Elimination – Biotransformation and
disposition of CYMBALTA in humans have been determined following oral
administration of 14C-labeled CYMBALTA. CYMBALTA comprises about 3% of the total
radiolabeled material in the plasma, indication that it undergoes extensive
metabolism to numerous metabolites. The major biotransformation pathways for
CYMBALTA involve oxidation of the naphthyl ring followed by conjugation and
further oxidation. Both CYP2D6 and CYP1A2 catalyze the oxidation of the naphthyl
ring in vitro. Metabolites found in plasma include 4 –hydroxy
duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate. Many
additional metabolites have been identified in urine, some representing only
minor pathways of elimination. Only trace (1% of the dose) amounts of unchanged
CYMBALTA are present in the urine. Most (about 70%) of the CYMBALTA dose appears
I the urine as metabolites of CYMBALTA; about 20% is excreted in the feces.
Smoking Status – CYMBALTA bioavailability (AUC)
appears to be reduced by about one-third in smokers. Dosage modifications are
not recommended for smokers.
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Race – No specific pharmacokinetic study was
conducted to investigate the effects of race.
Renal Insufficiency – Limited data are available
on the effects of CYMBALTA in patients with end stage renal disease (ESRD).
After a single 60-mg dose of CYMBALTA, Cmax
and AUC values were approximately 100% greater inpatients with end stage renal
disease receiving chronic intermittent hemodialysis than in subjects with normal
renal fuction. The elimination half-life, however, was similar in both groups.
The AUC’s of the major circulation metabolites, 4-hydroxy duloxetine glucuronide
and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were
approximately 7 – to 9 – fold higher and would be expected to increase further
with multiple dosing. For this reason, CYMBALTA is not recommended for patients
with ESRD (see DOSAGE AND ADMINISTATION). Studies have not been conducted in
patients with a moderate degree of renal dysfunction, but population PK analyses
suggest that mild renal dysfunction has no significant effect on CYMBALTA
apparent clearance.
Hepatic Insufficiency – Patients with clinically evident
hepatic insufficiency have decreased CYMBALTA metabolism and elimination. After
a single 20-mg dose of CYMBALTA 6 cirrhotic patients with moderate liver
impairment (Child-Pugh Class B) had a mean plasma CYMBALTA clearance about 15%
that of age- and gender-matched healthy subjects, with a 5-fold increase in mean
exposure (AUC). Although Cmax
was similar
to normals in the cirrhotic patients, the half-life was about 3 times longer
(see PRECAUTIONS). It is recommended that CYMBALTA no be administered to
patients with any hepatic insufficiency (see DOSAGE AND ADMINISTRATION).
Back
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Drug-Drug Interactions (also see PRECAUTIONS, Drug
Interactions)
Potential for Other Drugs to Affect CYMBALTA.
Both CYP1A2 and CYP2D6 are responsible for CYMBALTA
metabolism.
INDICATIONS AND USAGE
CYMBALTA is indicated for the treatment of major depressive
disorder (MDD).
CONTRAINDICATIONS
Hypersensitivity
CYMBALTA is contraindicated in patients with a known
hypersensitivity to the product.
Clinical Worsening and Suicide Risk – Patients
with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and
behavior (suicidality), whether or not they are taking antidepressant
medications, and this risk may persist until significant remission occurs.
Although there was been a long-standing concern that antidepressants may have a
role in inducing worsening of depression and the emergence of suicidality in
certain patients, a causal role for antidepressants in inducing such behaviors
has not been established. Nevertheless, patients being treated with
antidepressants should be observed closely for clinical worsening and
suicidality, especially at the beginning of a course of drug therapy, or at the
time of dose changes, either increases of decreases.
Consideration should
be given to changing the therapeutic regimen, including possibly discontinuing
the medication, in patients whose depression is persistently worse or whose
emergent suicidality is severe, abrupt in onset, or was not part of the
patient’s presenting symptoms.
Because of the possibility of co-morbidity between major
depressive disorder and other psychiatric and nonpsychiatric disorders, the same
precautions observed when treating patients with major depressive disorder
should be observed when treating patients with other psychiatric and
nonpsychiatric disorders.
The following symptoms – anxiety, agitation, panic
attacks, insomnia, irritability, hostility (aggressiveness), impulsivity,
akathisia (psychomotor restlessness), hypomania, and mania – have been reported
in adult and pediatric patients being treated with antidepressants for major
depressive disorder as well as for other indications, both psychiatric and
nonpsychiatric. Although a causal link between the emergence of such symptoms
and either the worsening of depression and/or the emergence of suicidal impulses
has not been established, consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the medications, in
patients for whom such symptoms are severe, abrupt in onset, or were not part of
the patient’s presenting symptoms.
Families and caregivers of patients being treated with
antidepressants for major depressive disorder or other indications, both
psychiatric and nonpsychiatric, should be alerted about the need to monitor
patients for the emergence of suicidality, and to report such symptoms
immediately to health care providers. Prescriptions for CYMBALTA should be
written for the smallest quantity of capsules consistent with good patient
management, in order to reduce the risk of overdose.
If the decision has been made to discontinue treatment,
medication should be tapered, as rapidly as is feasible, but with recognition
that abrupt discontinuation can be associated with certain symptoms (see
PRECAUTIONS and DOSAGE AND ADMINISTRATION, Discontinuing CYMBALTA (duloxetine
hydrochloride), for a description of the risks of discontinuation of CYMBALTA).
Physicians are advised to discuss the following
issues with patients for whom they prescribe CYMBALTA.
Patients and their families should be encouraged to be
alert to the emergence of anxiety, agitation, panic attacks, insomnia,
irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of
depression, and suicidal ideation, especially early during antidepressant
treatment. Such symptoms should be reported to the patient’s physician,
especially if they are severe, abrupt in onset, or were not part of the
patient’s presenting symptoms.
Any psychoactive drug may impair judgment, thinking, or
motor skills.
Drug Interactions (also see CLINICAL PHARMACOLOGY, Drug – Drug
Interactions)
Inhibitors of CYP2D6 – Because CYP2D6 is involved
in CYMBALTA metabolism, concomitant use of CYMBALTA with potent inhibitors of
CYP2D6 may result in higher concentrations of CYMBALTA. Paroxetine (20 mg QD)
increased the concentration of CYMBALTA (40 mg QD) by about 60%, and greater
degrees of inhibition are expected with higher doses of Paroxetine. Similar
effect would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine,
quinidine).
ADVERSE REACTIONS
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CYMBALTA has been evaluated for safety in 2418 patients
diagnosed with major depressive disorder who participated in multiple-dose
premarketing trials, representing 1099 patient-years of exposure. Among these
2418 CYMBALTA treated patients, 1139 patients participated in eight 8- or 9-
week, placebo-controlled trials at doses ranging from 40 to 120 mg/day, while
the remaining 1279 patients were followed for up to 1 year in an open-label
safety study using flexible doses from 80 to 120 mg/day. Two placebo-controlled
studies with doses of 80 to 120 mg/day had 6- month maintenance extensions. Of
these 2418 patients, 993 CYMBALTA-treated patients were exposed for at least 180
days and 445 CYMBALTA-treated patients were exposed for at least 1 year. Adverse
reactions were assessed by collecting adverse events, results of physical
examinations, vital signs, weights, laboratory analyses, and ECGs.
Clinical investigators recorded adverse events using
descriptive terminology of their own choosing. To provide a meaningful estimate
of the proportion of individuals experiencing adverse events, grouping similar
types of events into a smaller number of standardized event categories is
necessary. In the tables and tabulations that follow, MedDRA terminology has
been used to classify reported adverse events.
The stated frequencies of adverse events represent the
proportion of individuals who experienced, at least once, a treatment-emergent
adverse event of the type listed. An event was considered treatment-emergent if
it occurred for the first time or worsened while receiving therapy following
baseline evaluation. Events reported during the studies were not necessarily
caused by the therapy, and the frequencies do not reflect investigator
impression (assessment) of causality.
The cited figures provide the prescriber with some basis
for estimating the relative contribution of drug and non-drug factors to the
adverse event incidence rate in the population studied. The prescriber should be
aware that the figures in the tables and tabulations cannot be used to predict
the incidence of adverse events in the course of usual medical practice where
patient characteristics and other factors differ from those that prevailed in
the clinical trials. Similarly, the cited frequencies cannot be compared with
figures obtained from other clinical investigations involving different
treatments, uses, and investigators.
Adverse Events Reported as Reasons for Discontinuation of
Treatment in Placebo-Controlled Trials
Approximately 10% of the 1139 patients who
received CYMBALTA in the placebo-controlled trials discontinued treatment due to
an adverse event, compared with 4% of the 777 patients receiving placebo. Nausea
(CYMBALTA 1.4%, placebo 0.1%) was the only common adverse event reported as
reason for discontinuation and considered to be drug-related (i.e.,
discontinuation occurring in at least 1% of the CYMBALTA-treated patients and at
a rate of at least twice that of placebo).
Adverse Events Occurring at an Incidence of 2% or More
Among CYMBALTA-Treated Patients in Placebo-Controlled Trials
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Table 1 gives the incidence of treatment-emergent
adverse events that occurred in 2% or more of patients treated with CYMBALTA in
the acute phase of MDD placebo-controlled trials and with an incidence greater
than placebo. The most commonly observed adverse events in CYMBALTA-treated MDD
patients (incidence of 5% or greater and at least twice the incidence in placebo
patients) were nausea; dry mouth; constipation; decreased appetite; fatigue;
somnolence; and increased sweating.
Effects on Male and Female Sexual Function
Although changes in sexual desire, sexual performance and
sexual satisfaction often occur as manifestations of a psychiatric disorder,
they may also be a consequence of pharmacologic treatment. Reliable estimates of
the incidence and severity of untoward experiences involving sexual desire,
performance and satisfaction are difficult to obtain, however, in part because
patients and physicians may be reluctant to discuss them. Accordingly, estimates
of the incidence of untoward sexual experience and performance cited in product
labeling are likely to underestimate their actual incidence.
Other Adverse Events Observed During the Premarketing
Evaluation of CYMBALTA
Following is a list of modified MedDRA terms that reflect
treatment-emergent adverse events as defined in the introduction to the ADVERSE
REACTIONS section reported by patients treated with CYMBALTA at multiple doses
throughout the dose range studied during any phase of a trial within the
premarketing database. The events included are those not already listed
elsewhere in ADVERSE REACTIONS and not considered in the WARNINGS and
PRECAUTIONS sections, that were reported with an incidence of greater than or
equal to 0.05%, are not common as background events and were considered possibly
drug related (e.g., because of the drug’s pharmacology) or potentially
important.
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It is important to emphasize that, although the events
reported occurred during treatment with CYMBALTA, they were not necessarily
caused by it. Events are further categorized by body system and listed in order
of decreasing frequency according to the following definitions: frequent adverse
events are those occurring in at least 1/100 patients (only those not already
listed in the tabulated results from placebo-controlled trials appear in this
listing); infrequent adverse events are those occurring in 1/100 to 1/1000
patients; rare events are those occurring in fewer than 1/1000 patients.
Blood and Lymphatic System Disorders –
Infrequent: anemia, leukopenia, increased whit blood cell count,
lymphadenopathy, and thrombocytopenia.
Gastrointestinal Disorders –
Frequent:
gastritis: Infrequent: blood in stool, colitis, dysphagia, esophageal
stenosis acquired, gastric ulcer, gingivitis, irritable bowel syndrome, and
lower abdominal pain.
Psychiatric Disorders –
Frequent: initial
insomnia, irritability, lethargy, nervousness, nightmare, restlessness, and
sleep disorder; Infrequent: completed suicide, mania, mood swings,
pressure of speech, sluggishness, and suicide attempt.
Renal and Urinary Disorders –
Frequent:
dysuria; infrequent: micturition urgency, urinary hesitation, urinary
incontinence, urinary retention, and urine flow decreased.
Skin and Subcutaneous Tissue Disorders –
Frequent: night swats, pruritus, and rash;
Infrequent: acne,
alopecia, cold sweat, ecchymosis, eczema, erythema, face edema, increased
tendency to bruise, and photosensitivity reaction.
Vascular Disorders –
Infrequent: peripheral
edema and phlebitis.
Discontinuing CYMBALTA (duloxetine hydrochloride)
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Symptoms associated with discontinuation of
CYMBALTA and other SSRIs and SNRIs have been reported (see PRECAUTIONS).
Patients should be monitored for these symptoms when discontinuing treatment. A
gradual reduction in the dose rather than abrupt cessation is recommended
whenever possible. If intolerable symptoms occur following a decrease in the
dose or upon discontinuation of treatment, then resuming the previously
prescribed dose may be considered. Subsequently, the physician may continue
decreasing the dose but at a more gradual rate.
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