What the label lists and what reports show
Clomipramine side effects
Clomipramine's FDA label lists its adverse reactions in its own words. FAERS holds 4,505 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is somnolence (212 reports).
- Generic listed
- Boxed warning
Check it at the source: the clomipramine FDA label on DailyMed (effective November 26, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsCommonly Observed The most commonly observed adverse events associated with the use of clomipramine hydrochloride capsules 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 in U.S. premarketing clinical trials discontinued treatment because of an adverse event. …
Incidence of Treatment-Emergent Adverse Experience in Placebo-Controlled Clinical Trials (Percentage of Patients Reporting Event)
This table is printed in the Clomipramine Hydrochloride label published by Leading Pharma, LLC of December 26, 2025; the label quoted above does not print one.
| Reaction | Clomipramine hydrochloride (N=322) | Placebo (N=319) | Clomipramine hydrochloride (N=46) | Placebo (N=44) |
|---|---|---|---|---|
| Somnolence | 54 | 16 | 46 | 11 |
| Tremor | 54 | 2 | 33 | 2 |
| Dizziness | 54 | 14 | 41 | 14 |
| Headache | 52 | 41 | 28 | 34 |
| Insomnia | 25 | 15 | 11 | 7 |
| Libido change | 21 | 3 | - | - |
| Nervousness | 18 | 2 | 4 | 2 |
| Myoclonus | 13 | - | 2 | - |
| Increased appetite | 11 | 2 | - | 2 |
| Paresthesia | 9 | 3 | 2 | 2 |
| Memory impairment | 9 | 1 | 7 | 2 |
| Anxiety | 9 | 4 | 2 | - |
| Twitching | 7 | 1 | 4 | 5 |
| Impaired concentration | 5 | 2 | - | - |
| Depression | 5 | 1 | - | - |
| Hypertonia | 4 | 1 | 2 | - |
| Sleep disorder | 4 | - | 9 | 5 |
| Psychosomatic disorder | 3 | - | - | - |
| Yawning | 3 | - | - | - |
| Confusion | 3 | - | 2 | - |
| Speech disorder | 3 | - | - | - |
| Abnormal dreaming | 3 | - | - | 2 |
| Agitation | 3 | - | - | - |
| Migraine | 3 | - | - | - |
| Depersonalization | 2 | - | 2 | - |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, SpecGx LLC, effective November 26, 2024 (SPL set d7cee3fa-d05c-4702-8f75-f446627bdb49), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,505 reports list clomipramine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 394 are coded as a death and 2,429 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Clomipramine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions