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Citalopram
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| Body System/Adverse Event | Percentage of Patients Reporting | |
|---|---|---|
| Citalopram (n=1027) | Placebo (n=426) | |
|
| ||
| Body as a Whole | ||
| Fatigue | 5.2 | 3.1 |
| Fevers1 | 2.4 | 0.2 |
| Autonomic Nervous System | ||
| Dry mouth1 | 19.4 | 12.2 |
| Sweating increased | 10.5 | 8.0 |
| Central and Peripheral Nervous System | ||
| Tremor | 8.4 | 6.3 |
| Gastrointestinal System | ||
| Nausea1 | 20.6 | 13.4 |
| Diarrhea | 8.1 | 5.4 |
| Dyspepsia | 4.3 | 3.5 |
| Vomiting | 3.9 | 2.6 |
| Abdominal pain | 3.1 | 2.1 |
| Psychiatric | ||
| Somnolence1 | 17.3 | 9.9 |
| Anorexia1 | 4.2 | 1.6 |
| Nervousness | 3.6 | 3.5 |
| Anxiety | 3.3 | 2.1 |
| Agitation1 | 2.4 | 0.7 |
| Libido decreased1 | 2.2 | 0.2 |
| Yawning1 | 2.1 | 0 |
| Reproductive Female2 | ||
| Dysmenorrhea (<50 years) | 2.7 | 1.6 |
| Reproductive, Male3 | ||
| Ejaculation disorder1 | 6.2 | 1.1 |
| Impotence3 | 3.2 | 0.6 |
| Respiratory System | ||
| Upper respir. tract infection | 5.1 | 4.7 |
| Rhinitis | 4.9 | 3.3 |
| Pharyngitis | 3.4 | 2.8 |
| Sinusitis1 | 2.4 | 0.2 |
| Urinary System | ||
| Micturition disorder | 2.3 | 2.1 |
*Events included are those occurring in 2% or more of patients treated with citalopram, and for which the incidence in patients treated with citalopram was greater than the incidence in placebo-treated patients.
1Statistically significantly higher incidence in the citalopram group (p<0.05).
2Denominator used was for females only (n=623 for citalopram; n=245 for Placebo).
3Denominator used was for males only (n=404 for citalopram; n=181 for Placebo).
The following events had an incidence on placebo >= citalopram: asthenia, back pain, headache, dizziness, constipation, palpitation, insomnia, abnormal vision.
Most Frequent Adverse Events
Adverse events that occurred in citalopram-treated patients in the course of the short-term, placebo-controlled trials with an incidence greater than or equal to, 10% were: nausea, dry mouth, somnolence, and increased sweating (Table 1).
Dose Dependency of Adverse Events
The potential relationship between the dose of citalopram and the incidence of an adverse event was examined in a fixed dose short-term, placebo-controlled study in which patients received citalopram at doses of 10, 20, 40 or 60 mg per day. The incidence of insomnia, increased sweating, and fatigue was dose-related.
Male and Female Sexual Dysfunction with SSRIs
While sexual dysfunction is often part of depression and other psychiatric disorders, there is increasing evidence that treatment with selective serotonin reuptake inhibitors (SSRIs) may induce sexual side effects. This is a difficult area to study because patients may not spontaneously report symptoms of this nature, and therefore, it is
thought that sexual side effects with SSRIs may be underestimated.
In placebo-controlled, short-term clinical trials, the reported incidence of decreased libido, ejaculation disorders (primarily ejaculation delay and ejaculation failure), and impotence in male depressed patients receiving citalopram (n=404) was 3.7%, 6.2%, and 3.2%, respectively. In female depressed patients receiving citalopram (n=623), the reported incidence of decreased libido and anorgasmia was 1.3% and 1.1%, respectively. The reported incidence of each of these adverse events was <=1% among male and female depressed patients receiving placebo.
Weight Changes
Patients treated with citalopram in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.
ECG
Retrospective analyses of electrocardiograms in citalopram-treated (n=779 <60 years and n=313 >=60 years) and placebo-treated (n=74 <60 years and n=43 >=60 years) patients indicated that citalopram decreases heart rate. In patients <60 years old, the mean decrease was approximately 5 bpm, while in patients >=60 years
old, mean decreases ranged between 5 to 10 bpm. Following the initial drop, heart rate remained decreased but stable over prolonged periods of time (up to one year in over 100 younger and over 50 elderly patients). The effect was reversible within approximately a week after stopping treatment.
In the 6-week, fixed dose, dose-response study, the mean decreases in heart rate ranged between 2-6 bpm in the 20-60 mg/day dose range, but the effect did not seem to be dose-related and was independent of gender. In placebo-treated patients heart rates remained unaffected. The differences in heart rates between citalopram and placebo-treated patients were statistically significant. ECG parameters, including QT interval, remained unaffected.
Clinical Trials, Drug Interactions,
Over dosage, Dosage, Pharmaceutical Information