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chlorpromazine Side Effects

Also known as: Thorazine

Analysis of 6,862 adverse event reports submitted to the FDA from 2001 to 2025.

Total Reports

6,862

Death-Related

1,285

18.7% of reports

Hospitalizations

3,175

46.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
527
OFF LABEL USE
432
TOXICITY TO VARIOUS AGENTS
425
OVERDOSE
345
DRUG INTERACTION
321
NEUROLEPTIC MALIGNANT SYNDROME
280
NAUSEA
272
NEUTROPENIA
263
FATIGUE
253
DIARRHOEA
252
VOMITING
239
PSYCHOTIC DISORDER
231
SOMNOLENCE
228
SUICIDE ATTEMPT
214
HYPOTENSION
200
SEIZURE
199
CONDITION AGGRAVATED
198
AGGRESSION
193
DRUG ABUSE
193
DEATH
192

Who Reports Side Effects

Gender Distribution

Female 2,718 (44%)
Male 3,446 (56%)
Unknown 23

Age Distribution

0-17 528 (10%)
18-44 2,144 (40%)
45-64 1,766 (33%)
65-74 625 (12%)
75+ 318 (6%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 1,285 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
TOXICITY TO VARIOUS AGENTS 245
DEATH 192
COMPLETED SUICIDE 188
OVERDOSE 146
OFF LABEL USE 104
DIARRHOEA 96
FATIGUE 89
NAUSEA 89
NEUTROPENIA 89
PLATELET COUNT DECREASED 84
LEUKOPENIA 83
SEIZURE 83
CARDIAC ARREST 81
SCHIZOPHRENIA 81
DISEASE PROGRESSION 79
NEUTROPHIL COUNT INCREASED 79
PSYCHOTIC DISORDER 78
DRUG INTERACTION 77
EXTRAPYRAMIDAL DISORDER 77
AFFECTIVE DISORDER 76

Reactions in Hospitalization Reports

Top reactions in 3,175 reports where hospitalization was an outcome.

Reaction Reports
OFF LABEL USE 255
DRUG INEFFECTIVE 233
OVERDOSE 218
NEUROLEPTIC MALIGNANT SYNDROME 217
DIARRHOEA 186
TOXICITY TO VARIOUS AGENTS 181
PSYCHOTIC DISORDER 176
NAUSEA 172
NEUTROPENIA 152
SEIZURE 147
VOMITING 139
HYPOTENSION 134
DRUG INTERACTION 133
SCHIZOPHRENIA 128
FATIGUE 127
EXTRAPYRAMIDAL DISORDER 117
HALLUCINATION, AUDITORY 117
PYREXIA 117
SOMNOLENCE 110
AGGRESSION 106

Nearby — Related Medications

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What the FAERS Data Reveals About chlorpromazine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 6,862 voluntary reports linked to chlorpromazine and its brand equivalents (Thorazine), spanning 2001 through 2025. Of those, 1,285 (18.7%) listed death as an outcome and 3,175 (46.3%) 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, 44% were female and 56% male; age distribution skews toward 18-44, with 2,144 reports in that bracket. The single most reported reaction is drug ineffective with 527 submissions, followed by off label use and toxicity to various agents.

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.