Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Commonly Observed The most commonly observed adverse events associated with the use of clomipramine hydrochloride capsules, USP and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia;
nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus;
genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder;
and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.
Leading to Discontinuation of Treatment Approximately 20% of 3616 patients who received clomipramine hydrochloride capsules, USP in U.S.
premarketing clinical trials discontinued treatment because of an adverse event.
Approximately one-half of the patients who discontinued (9% of the total) had multiple complaints, none of which could be classified as primary.
Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence.
The second-most-frequent reason for discontinuation was digestive system complaints (1.3%), primarily vomiting and nausea.
There was no apparent relationship between the adverse events and elevated plasma drug concentrations.
WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24;
Like all medications, Clomipramine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: