Cipram Adverse Reactions

Adverse effects observed with citalopram are in general mild and transient. They are most frequent during the first one or two weeks of treatment and usually attenuate subsequently. The adverse reactions are presented at the MedDRA Preferred Term Level.
Clinical trials: The most commonly observed adverse reactions associated with the use of citalopram (N=1346) in double-blind, placebo-controlled trials and not seen at an equal incidence among placebo-treated patients (N=545) were: Sweating increased, dry mouth, agitation, appetite decreased, impotence, libido decreased, somnolence, yawning, nausea, ejaculation disorder, ejaculation failure, and abnormal orgasm (female). The incidence of each in excess over placebo is low (<10%). For the following reactions, a dose-response was discovered: Sweating increased, dry mouth, insomnia, somnolence, diarrhea, nausea, and fatigue.
The table shows the percentage of adverse drug reactions associated with citalopram seen in ≥1% of patients in double-blind placebo-controlled trials. (See table.)

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In comparative double-blind clinical trials with tri- and tetracyclic antidepressants (TTCAs), the incidence of 10 adverse reactions was statistically significantly higher on TTCAs (N=389) (dry mouth, sweating increased, constipation, tremor, dizziness, somnolence, accommodation abnormal, postural hypotension, palpitation, dysgeusia) compared to citalopram (N=682). For two reactions (nausea, ejaculation disorder), the incidence was statistically significantly higher on citalopram compared to TTCAs.
In the comparative trials versus other SSRIs, no statistically significant differences between the groups were found.
Post-marketing reports: In addition to the adverse drug reactions seen in the clinical trials, the following have been observed during post-marketing surveillance.
Very rare (<1/10,000): Hyponatraemia, inappropriate ADH secretion (both in especially elderly women), hypersensitivity NOS, convulsions NOS, grand mal convulsion, serotonin syndrome, drug withdrawal syndrome (dizziness (exc. vertigo), nausea and paraesthesia NEC), ecchymosis, purpura NOS, extrapyramidal disorder NEC.
Bone fractures: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.
QT interval prolongation: Cases of QT prolongation and ventricular arrhythmia including torsade de pointes have been reported during post-marketing period, predominantly in patients of female gender, with hypokalaemia or with pre-existing QT interval prolongation or other cardiac diseases (see Contraindications, Precautions, Interactions, Overdosage, and Pharmacology: Pharmacodynamics under Actions).