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The physician’s psychoactive medication resource guide
25% of your patients taking an antidepressant will have
weight gain and the weight gain is directly caused by the antidepressant.
Elderly people with psychosis related to dementia (for example, an inability to
perform daily activities as a result of increased memory loss), treated with
antipsychotic medicines including ABILIFY, are at an increased risk of death
compared to placebo. ABILIFY is not approved for the treatment of people with
dementia-related psychosis (see Boxed WARNING).
Antidepressants may increase suicidal thoughts or behaviors in some children,
teenagers, and young adults, especially within the first few months of treatment or
when the dose is changed. Depression and other serious mental illnesses are
themselves associated with an increase in the risk of suicide. Patients on
antidepressants and their families or caregivers should watch for new or worsening
depression symptoms, unusual changes in behavior, or thoughts of suicide. Such
symptoms should be reported to the patient’s healthcare professional right away,
especially if they are severe or occur suddenly. ABILIFY is not approved for use in
pediatric patients with depression (see Boxed WARNING).
Patients should not use ABILIFY if they are allergic to aripiprazole or any of the
ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching
to anaphylaxis, which may include difficulty breathing, tightness in the chest, and
swelling of the mouth, face, lips, or tongue.
Serious side effects may include:
An increased risk of stroke and ministroke have been reported in clinical studies of
elderly people with dementia-related psychosis
Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate
and blood pressure. These may be signs of a condition called neuroleptic malignant
syndrome (NMS), a rare but serious side effect which could be fatal
Uncontrollable movements of face, tongue, or other parts of body, as these may be
signs of a serious condition called tardive dyskinesia (TD). TD may become
permanent and the risk of TD may increase with the length of treatment and the
overall dose. While TD can develop after taking the medicine at low doses for short
periods, this is much less common. There is no known treatment for TD, but it may
go away partially or completely if the medicine is stopped
If you have diabetes, or risk factors for diabetes (for example, obesity, family history
of diabetes), or unexpected increases in thirst, urination, or hunger, your blood sugar
should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases
serious and associated with coma or death, have been reported in patients taking
ABILIFY and medicines like it
Lightheadedness or faintness caused by a sudden change in heart rate and blood
pressure when rising quickly from a sitting or lying position (orthostatic
hypotension) has been reported with ABILIFY.
Decreases in white blood cells (infection fighting cells) have been reported in some
patients taking antipsychotic agents, including ABILIFY. Patients with a history of a
significant decrease in white blood cell (WBC) count or who have experienced a low
WBC count due to drug therapy should have their blood tested and monitored
during the first few months of therapy.
ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous
machinery until you know how ABILIFY affects you.
Medicines like ABILIFY can impact your body’s ability to reduce body temperature; you should avoid overheating and
ABILIFY and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing
problems, you should tell your healthcare professional.
Tell your healthcare professional if you have a history of or are at risk for seizures, or are pregnant or intend to become
pregnant. Also tell your healthcare professional about all prescription and non-prescription medicines you are taking or plan
to take since there are some risks for drug interactions.
While taking ABILIFY, avoid:
•Breast-feeding an infant
Most common side effects (=10%) from all clinical trials involving adults or pediatric patients include:
ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia),
anxiety, insomnia, and restlessness
PEDIATRIC PATIENTS (6 to 17 years): Sleepiness, headache, vomiting, extrapyramidal disorder (for example, uncontrolled
movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), fatigue, increased appetite,
insomnia, nausea, stuffy nose, and weight gain
It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasms or contractions,
which may be signs of a condition called dystonia.
For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.
For patients with phenylketonuria or PKU, ABILIFY DISCMELT® (aripiprazole) contains phenylalanine.
If you have any questions about your health or medicines, talk to your healthcare professional.
INDICATIONS: ABILIFY is indicated for:
•Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate
response to antidepressant therapy
•Treatment of manic and mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years
•Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
•Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age
Special Considerations for Pediatric Uses:
•Discuss the risks and benefits of treatment with your child’s healthcare provider. Treatment should be started only after a
thorough diagnostic evaluation and as part of a total treatment program