Clomipramine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Clomipramine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Dry mouth | 84% |
| Somnolence | 54% |
| Tremor | 54% |
| Dizziness | 54% |
| Headache | 52% |
| Constipation | 47% |
| Ejaculation failure | 42% |
| Fatigue | 39% |
| Nausea | 33% |
| Increased sweating | 29% |
| Insomnia | 25% |
| Dyspepsia | 22% |
| Anorexia | 22% |
| Libido change | 21% |
| Impotence | 20% |
| Nervousness | 18% |
| Weight increase | 18% |
| Abnormal vision | 18% |
| Abdominal pain | 16% |
| Pharyngitis | 14% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients t…
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