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clomipramine Side Effects

Also known as: Anafranil

Analysis of 4,403 adverse event reports submitted to the FDA from 1998 to 2025.

Total Reports

4,403

Death-Related

393

8.9% of reports

Hospitalizations

2,376

54.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INTERACTION
225
SOMNOLENCE
203
FALL
202
OFF LABEL USE
193
TREMOR
185
NAUSEA
173
SUICIDE ATTEMPT
169
INTENTIONAL OVERDOSE
168
DRUG INEFFECTIVE
166
COMA
160
CONFUSIONAL STATE
160
ANXIETY
157
DEPRESSION
144
MALAISE
143
TACHYCARDIA
141
ASTHENIA
140
DIZZINESS
136
FATIGUE
136
DYSPNOEA
135
OVERDOSE
134

Who Reports Side Effects

Gender Distribution

Female 2,492 (60%)
Male 1,643 (40%)
Unknown 13

Age Distribution

0-17 184 (6%)
18-44 883 (26%)
45-64 1,216 (36%)
65-74 543 (16%)
75+ 508 (15%)

Reporting Trend by Year

1998 2025

Reactions in Death Reports

Top reactions reported in 393 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 56
COMPLETED SUICIDE 38
CARDIAC ARREST 26
CARDIO-RESPIRATORY ARREST 25
PYREXIA 23
TOXICITY TO VARIOUS AGENTS 20
DYSPNOEA 18
VOMITING 18
INTENTIONAL OVERDOSE 17
COMA 16
DRUG INTERACTION 16
DEPRESSED LEVEL OF CONSCIOUSNESS 15
NAUSEA 15
AGITATION 14
PNEUMONIA 14
SEPTIC SHOCK 14
PNEUMONIA ASPIRATION 13
SUDDEN DEATH 13
TOXIC EPIDERMAL NECROLYSIS 13
FOETAL EXPOSURE DURING PREGNANCY 12

Reactions in Hospitalization Reports

Top reactions in 2,376 reports where hospitalization was an outcome.

Reaction Reports
FALL 167
DRUG INTERACTION 144
SUICIDE ATTEMPT 138
TREMOR 132
CONFUSIONAL STATE 124
INTENTIONAL OVERDOSE 121
SOMNOLENCE 117
OFF LABEL USE 104
COMA 97
ASTHENIA 95
OVERDOSE 93
PYREXIA 89
TOXICITY TO VARIOUS AGENTS 89
SOPOR 88
DRUG ABUSE 86
LOSS OF CONSCIOUSNESS 86
NAUSEA 85
TACHYCARDIA 85
HYPOTENSION 84
DEPRESSION 83

Nearby — Related Medications

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What the FAERS Data Reveals About clomipramine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 4,403 voluntary reports linked to clomipramine and its brand equivalents (Anafranil), spanning 1998 through 2025. Of those, 393 (8.9%) listed death as an outcome and 2,376 (54.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 40% male; age distribution skews toward 45-64, with 1,216 reports in that bracket. The single most reported reaction is drug interaction with 225 submissions, followed by somnolence and fall.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.