Clomipramine Hydrochloride side effects: what 4,504 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Clomipramine Hydrochloride (Clomipramine Hydrochloride)
Who reports
4,504 reports · 92% serious · 394 with death outcome · 60% female
Used for
Clomipramine hydrochloride capsules, USP is 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.
What it is
DESCRIPTION Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration.
Boxed warning
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 298 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sopor | 120 | 42.2 35.3–50.4ROR 43.3 · χ² 4,742 / p <1e-300 | 41.5 EB05 35.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 | no trial data cached |
| Poisoning deliberate | 75 | 37.8 30.2–47.4ROR 38.5 · χ² 2,632 / p <1e-300 | 37.2 EB05 30.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 · 97% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 80 | 31.5 25.4–39.2ROR 32.1 · χ² 2,320 / p <1e-300 | 31.1 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 | no trial data cached |
| Intentional self-injury | 108 | 25.1 20.8–30.2ROR 25.6 · χ² 2,459 / p <1e-300 | 24.8 EB05 21.1 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 | no trial data cached |
| Serotonin syndrome | 80 | 19.6 15.7–24.3ROR 19.9 · χ² 1,385 / p <1e-300 | 19.4 EB05 16.1 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.3 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 40 | 18.4 13.5–25.0ROR 18.5 · χ² 637 / p 6e-141 | 18.1 EB05 13.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 92% clinician | no trial data cached |
| Coma | 175 | 17.2 14.8–19.8ROR 17.8 · χ² 2,642 / p <1e-300 | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 | no trial data cached |
| Akathisia (inner restlessness) | 47 | 16.1 12.1–21.4ROR 16.2 · χ² 648 / p 3e-143 | 15.9 EB05 12.4 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 | no trial data cached |
| Obesity | 52 | 15.2 11.6–20.0ROR 15.4 · χ² 675 / p 4e-149 | 15.0 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Altered state of consciousness | 64 | 13.9 10.9–17.7ROR 14.1 · χ² 750 / p 2e-165 | 13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Suicide attempt | 173 | 13.3 11.5–15.4ROR 13.8 · χ² 1,954 / p <1e-300 | 13.2 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.4 | no trial data cached |
| Toxic skin eruption | 28 | 12.9 8.9–18.7ROR 13.0 · χ² 296 / p 1e-66 | 12.4 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Intentional overdose | 175 | 12.8 11.1–14.8ROR 13.3 · χ² 1,895 / p <1e-300 | 12.7 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 46 | 12.3 9.2–16.4ROR 12.4 · χ² 466 / p 1e-103 | 12.0 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Electrocardiogram qt prolonged | 94 | 12.2 10.0–14.9ROR 12.4 · χ² 954 / p 1e-209 | 12.0 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Drug withdrawal syndrome neonatal | 36 | 11.2 8.1–15.6ROR 11.3 · χ² 325 / p 6e-73 | 10.7 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 37% (drug 60%) | no trial data cached |
| Hyperlipidaemia | 28 | 10.9 7.5–15.8ROR 11.0 · χ² 242 / p 9e-55 | 10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Hepatocellular injury | 33 | 10.8 7.7–15.2ROR 10.9 · χ² 284 / p 5e-64 | 10.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 94% clinician | no trial data cached |
| Depressed level of consciousness | 90 | 10.6 8.7–13.1ROR 10.8 · χ² 776 / p 4e-171 | 10.4 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Sputum discoloured | 21 | 10.4 6.8–15.9ROR 10.4 · χ² 168 / p 9e-39 | 9.4 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 100% (drug 60%) | no trial data cached |
| Hepatic cytolysis | 26 | 9.9 6.8–14.6ROR 10.0 · χ² 200 / p 1e-45 | 9.1 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 92% clinician | no trial data cached |
| Muscle rigidity | 25 | 9.8 6.6–14.4ROR 9.8 · χ² 188 / p 5e-43 | 8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Euphoric mood | 21 | 9.5 6.2–14.6ROR 9.5 · χ² 151 / p 5e-35 | 8.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Myoclonus | 24 | 9.4 6.3–14.0ROR 9.4 · χ² 171 / p 2e-39 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Extrapyramidal disorder | 50 | 9.3 7.1–12.3ROR 9.4 · χ² 362 / p 6e-81 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 38% (drug 60%) | no trial data cached |
| Parkinsonism | 19 | 9.1 5.8–14.2ROR 9.1 · χ² 129 / p 4e-30 | 8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hallucination, auditory | 29 | 8.5 5.9–12.2ROR 8.5 · χ² 184 / p 3e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Drug toxicity | 25 | 8.4 5.7–12.5ROR 8.5 · χ² 156 / p 3e-36 | 7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Prescribed overdose | 35 | 8.4 6.1–11.7ROR 8.5 · χ² 222 / p 2e-50 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Apathy | 26 | 8.3 5.7–12.2ROR 8.4 · χ² 161 / p 4e-37 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Secretion discharge | 22 | 8.3 5.5–12.6ROR 8.3 · χ² 134 / p 3e-31 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 100% (drug 60%) | no trial data cached |
| Hypercholesterolaemia | 17 | 8.3 5.2–13.3ROR 8.3 · χ² 102 / p 3e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pneumonia aspiration | 44 | 8.2 6.1–11.1ROR 8.3 · χ² 272 / p 2e-61 | 7.7 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Circulatory collapse | 30 | 8.2 5.7–11.7ROR 8.2 · χ² 182 / p 1e-41 | 7.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 81% (drug 60%) | no trial data cached |
| Drug exposure during pregnancy | 59 | 8.0 6.2–10.3ROR 8.1 · χ² 353 / p 5e-79 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Blood iron decreased | 20 | 7.9 5.1–12.3ROR 7.9 · χ² 114 / p 7e-27 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · ♀ 100% (drug 60%) | no trial data cached |
| Cyst | 21 | 7.9 5.1–12.1ROR 7.9 · χ² 119 / p 5e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 100% (drug 60%) | no trial data cached |
| Hypothermia | 17 | 7.8 4.9–12.6ROR 7.8 · χ² 94 / p 1e-22 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Mental disorder | 73 | 7.8 6.2–9.8ROR 7.9 · χ² 427 / p 4e-95 | 7.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · ♀ 85% (drug 60%) | no trial data cached |
| Vitamin d deficiency | 16 | 7.7 4.7–12.5ROR 7.7 · χ² 86 / p 9e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug interaction | 228 | 6.7 5.9–7.6ROR 7.0 · χ² 1,107 / p 6e-243 | 6.6 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Somnolence (drowsiness) | 212 | 4.9 4.3–5.6ROR 5.1 · χ² 663 / p 2e-146 | 4.9 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Fall | 208 | 2.9 2.6–3.3ROR 3.0 · χ² 264 / p 1e-59 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Tremor (shaking) | 187 | 5.2 4.6–6.0ROR 5.4 · χ² 642 / p 6e-142 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Intentional overdose | 175 | 12.8 11.1–14.8ROR 13.3 · χ² 1,895 / p <1e-300 | 12.7 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Coma | 175 | 17.2 14.8–19.8ROR 17.8 · χ² 2,642 / p <1e-300 | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 | no trial data cached |
| Suicide attempt | 173 | 13.3 11.5–15.4ROR 13.8 · χ² 1,954 / p <1e-300 | 13.2 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.4 | no trial data cached |
| Confusional state (confusion) | 160 | 4.6 4.0–5.4ROR 4.7 · χ² 451 / p 2e-100 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Anxiety | 159 | 2.6 2.2–3.0ROR 2.7 · χ² 156 / p 3e-36 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Depression | 144 | 2.9 2.5–3.4ROR 3.0 · χ² 184 / p 4e-42 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.3 | no trial data cached |
| Tachycardia (fast heart rate) | 141 | 7.4 6.3–8.7ROR 7.6 · χ² 776 / p 4e-171 | 7.2 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Overdose | 135 | 2.9 2.5–3.4ROR 3.0 · χ² 168 / p 9e-39 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Constipation | 133 | 2.9 2.4–3.4ROR 2.9 · χ² 161 / p 4e-37 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Toxicity to various agents | 128 | 3.6 3.0–4.2ROR 3.6 · χ² 234 / p 4e-53 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 90% clinician | no trial data cached |
| Hypotension (low blood pressure) | 123 | 2.9 2.4–3.4ROR 2.9 · χ² 148 / p 2e-34 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sopor — n=120, PRR 42.2
- Poisoning deliberate — n=75, PRR 37.8
- Neuroleptic malignant syndrome — n=80, PRR 31.5
- Obesity — n=52, PRR 15.2
- Altered state of consciousness — n=64, PRR 13.9
- Toxic skin eruption — n=28, PRR 12.9
- Orthostatic hypotension — n=46, PRR 12.3
- Electrocardiogram qt prolonged — n=94, PRR 12.2
- Drug withdrawal syndrome neonatal — n=36, PRR 11.2
- Hyperlipidaemia — n=28, PRR 10.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Clomipramine?
In FDA FAERS, the most frequently co-reported reaction terms for Clomipramine are somnolence, fall, tremor, coma, suicide attempt, confusional state. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Clomipramine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Do FAERS signals prove that Clomipramine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0bbee292-0fba-4606-9c8e-4723742682c0, effective 20250513; matched on
openfda.generic_name.exact:"CLOMIPRAMINE HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 338 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.