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disulfiram Side Effects

Also known as: Antabuse

Analysis of 1,076 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

1,076

Death-Related

111

10.3% of reports

Hospitalizations

504

46.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
123
DRUG INTERACTION
120
FATIGUE
82
TOXICITY TO VARIOUS AGENTS
63
DRUG INEFFECTIVE
61
NAUSEA
48
CONFUSIONAL STATE
47
PSYCHIATRIC SYMPTOM
44
OVERDOSE
43
DRUG ABUSE
41
DRUG-INDUCED LIVER INJURY
40
ANXIETY
37
CONDITION AGGRAVATED
36
TOXIC ENCEPHALOPATHY
36
SOMNOLENCE
35
ACUTE KIDNEY INJURY
33
NEUROPATHY PERIPHERAL
33
VOMITING
32
ASTHENIA
31
MALAISE
31

Who Reports Side Effects

Gender Distribution

Female 342 (35%)
Male 639 (65%)
Unknown 2

Age Distribution

0-17 24 (3%)
18-44 353 (41%)
45-64 393 (45%)
65-74 86 (10%)
75+ 9 (1%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 111 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 19
CARDIAC ARREST 18
COMPLETED SUICIDE 18
TOXICITY TO VARIOUS AGENTS 16
RESPIRATORY ARREST 12
CARDIO-RESPIRATORY ARREST 10
OFF LABEL USE 10
LACTIC ACIDOSIS 9
DRUG INTERACTION 8
DRUG-INDUCED LIVER INJURY 8
RENAL FAILURE 8
ACUTE HEPATIC FAILURE 5
DRUG ABUSE 5
HEPATIC FAILURE 5
HYPOTENSION 5
MULTI-ORGAN FAILURE 5
ALCOHOL INTOLERANCE 4
CONFUSIONAL STATE 4
CONVULSION 4
DYSPNOEA 4

Reactions in Hospitalization Reports

Top reactions in 504 reports where hospitalization was an outcome.

Reaction Reports
DRUG INTERACTION 82
TOXICITY TO VARIOUS AGENTS 37
OVERDOSE 35
CONFUSIONAL STATE 32
OFF LABEL USE 30
ACUTE KIDNEY INJURY 29
TOXIC ENCEPHALOPATHY 29
NAUSEA 27
MILK-ALKALI SYNDROME 26
SOMNOLENCE 26
DRUG ABUSE 25
FATIGUE 25
HYPERCALCAEMIA 25
VOMITING 25
CONDITION AGGRAVATED 24
MALAISE 24
ASTHENIA 23
PSYCHOTIC DISORDER 20
ENCEPHALOPATHY 19
SUICIDE ATTEMPT 19

Nearby — Related Medications

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What the FAERS Data Reveals About disulfiram Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 1,076 voluntary reports linked to disulfiram and its brand equivalents (Antabuse), spanning 2004 through 2025. Of those, 111 (10.3%) listed death as an outcome and 504 (46.8%) 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, 35% were female and 65% male; age distribution skews toward 45-64, with 393 reports in that bracket. The single most reported reaction is off label use with 123 submissions, followed by drug interaction and fatigue.

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.