Disulfiram side effects: what 1,124 FDA adverse event reports show

Disulfiram · 73 reaction terms · 1,136 drug–reaction co-reports · data 2026-09-14

Drug class

Aldehyde Dehydrogenase Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

1,124 reports · 89% serious · 113 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism..

FDA label, Indications and Usage

What it is

DESCRIPTION: Disulfiram is an alcohol antagonist drug.

FDA label, Description section

Boxed warning

Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge. The physician should instruct relatives accordingly.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 2Labeled (related wording) 2Reporting / coding artifact 4Not in label — unassessed 32

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 (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.
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. 33 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hypercalcaemia	25	37.9 25.7–55.8ROR 38.7 · χ² 860 / p 2e-189	36.8 EB05 26.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.3 · ♀ 5% (drug 35%) · 92% clinician	no trial data cached
Generalised tonic-clonic seizure	27	30.8 21.2–44.8ROR 31.6 · χ² 749 / p 3e-165	30.2 EB05 21.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · ♀ 0% (drug 35%) · 100% clinician	no trial data cached
Drug-induced liver injury	40	24.2 17.9–32.8ROR 25.1 · χ² 868 / p 5e-191	24.0 EB05 18.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.5 · ♀ 66% (drug 35%) · 100% clinician	no trial data cached
Polyneuropathy	15	23.6 14.2–38.9ROR 23.9 · χ² 302 / p 8e-68	22.9 EB05 14.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Myoclonus	15	23.5 14.2–38.9ROR 23.8 · χ² 301 / p 1e-67	22.8 EB05 14.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Sopor	16	22.4 13.7–36.4ROR 22.7 · χ² 305 / p 1e-68	21.7 EB05 14.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Neuroleptic malignant syndrome	14	22.0 13.1–37.0ROR 22.3 · χ² 260 / p 1e-58	21.3 EB05 13.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
Parkinsonism	11	21.1 11.7–37.9ROR 21.3 · χ² 191 / p 1e-43	20.0 EB05 11.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Encephalopathy	27	20.6 14.2–29.9ROR 21.1 · χ² 484 / p 2e-107	20.3 EB05 14.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.4 · 92% clinician	no trial data cached
Mania	18	20.5 12.9–32.4ROR 20.8 · χ² 314 / p 2e-70	20.0 EB05 13.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
Hypokinesia	15	19.3 11.7–31.9ROR 19.5 · χ² 242 / p 8e-55	18.6 EB05 11.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Psychotic disorder	30	19.0 13.3–27.0ROR 19.5 · χ² 493 / p 2e-109	18.7 EB05 13.7 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0 · 93% clinician	no trial data cached
Neurotoxicity	17	18.3 11.4–29.3ROR 18.5 · χ² 260 / p 7e-59	17.7 EB05 11.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Intentional self-injury	18	16.7 10.5–26.3ROR 16.9 · χ² 249 / p 2e-56	16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 10.9	no trial data cached
Delusion	13	15.7 9.1–26.9ROR 15.8 · χ² 164 / p 7e-38	14.6 EB05 8.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Thinking abnormal	15	14.9 9.0–24.7ROR 15.1 · χ² 182 / p 1e-41	14.0 EB05 8.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Drug interaction	122	14.4 12.1–17.0ROR 16.0 · χ² 1,513 / p <1e-300	14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7 · 93% clinician	no trial data cached
Acute hepatic failure	10	13.7 7.4–25.4ROR 13.8 · χ² 106 / p 5e-25	11.9 EB05 5.9 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.9	no trial data cached
Delirium	24	13.0 8.7–19.3ROR 13.2 · χ² 253 / p 3e-57	12.4 EB05 8.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · ♀ 10% (drug 35%) · 95% clinician	no trial data cached
Mental impairment	16	12.3 7.6–20.0ROR 12.5 · χ² 155 / p 6e-36	11.2 EB05 6.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Paranoia	11	11.9 6.6–21.3ROR 12.0 · χ² 99 / p 1e-23	10.0 EB05 5.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Disorientation	23	10.8 7.2–16.2ROR 11.0 · χ² 195 / p 1e-44	10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Dysarthria (slurred speech)	20	9.9 6.4–15.3ROR 10.1 · χ² 152 / p 3e-35	8.9 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Drug abuse	44	9.8 7.3–13.1ROR 10.2 · χ² 341 / p 2e-76	9.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5 · 95% clinician	no trial data cached
Suicide attempt	31	9.5 6.7–13.5ROR 9.8 · χ² 229 / p 6e-52	8.8 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 69% (drug 35%) · 94% clinician	no trial data cached
Epilepsy	15	9.2 5.5–15.2ROR 9.3 · χ² 101 / p 4e-24	7.8 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.0	no trial data cached
Fear	13	9.0 5.2–15.4ROR 9.0 · χ² 84 / p 2e-20	7.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Metabolic acidosis	15	8.8 5.3–14.6ROR 8.9 · χ² 97 / p 4e-23	7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Hepatic failure	14	8.6 5.1–14.6ROR 8.7 · χ² 87 / p 5e-21	7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.6	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	10	8.4 4.5–15.5ROR 8.4 · χ² 58 / p 1e-14	6.5 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Jaundice (yellowing of skin/eyes)	12	8.3 4.7–14.6ROR 8.4 · χ² 70 / p 3e-17	6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Panic attack	16	8.2 5.0–13.3ROR 8.3 · χ² 94 / p 2e-22	7.0 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Respiratory arrest	12	8.1 4.6–14.1ROR 8.1 · χ² 67 / p 1e-16	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Product prescribing error	10	7.9 4.3–14.6ROR 7.9 · χ² 53 / p 1e-13	6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.7	no trial data cached
Premature baby	12	7.4 4.2–13.0ROR 7.5 · χ² 60 / p 4e-15	6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Disturbance in attention	21	7.2 4.7–11.1ROR 7.4 · χ² 107 / p 2e-25	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 95% clinician	no trial data cached
Toxicity to various agents	64	7.1 5.6–9.0ROR 7.5 · χ² 333 / p 1e-74	6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.8 · 98% clinician	no trial data cached
Rhabdomyolysis (muscle breakdown)	15	6.7 4.1–11.1ROR 6.8 · χ² 68 / p 1e-16	5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Mental disorder	15	6.4 3.9–10.6ROR 6.5 · χ² 63 / p 8e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Lactic acidosis	10	5.8 3.1–10.8ROR 5.9 · χ² 35 / p 1e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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	122	14.4 12.1–17.0ROR 16.0 · χ² 1,513 / p <1e-300	14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7 · 93% clinician	no trial data cached
Toxicity to various agents	64	7.1 5.6–9.0ROR 7.5 · χ² 333 / p 1e-74	6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.8 · 98% clinician	no trial data cached
Drug abuse	44	9.8 7.3–13.1ROR 10.2 · χ² 341 / p 2e-76	9.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5 · 95% clinician	no trial data cached
Drug-induced liver injury	40	24.2 17.9–32.8ROR 25.1 · χ² 868 / p 5e-191	24.0 EB05 18.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.5 · ♀ 66% (drug 35%) · 100% clinician	no trial data cached
Suicide attempt	31	9.5 6.7–13.5ROR 9.8 · χ² 229 / p 6e-52	8.8 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 69% (drug 35%) · 94% clinician	no trial data cached
Psychotic disorder	30	19.0 13.3–27.0ROR 19.5 · χ² 493 / p 2e-109	18.7 EB05 13.7 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0 · 93% clinician	no trial data cached
Suicidal ideation (thoughts of suicide)	28	5.7 4.0–8.2ROR 5.8 · χ² 104 / p 9e-25	5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached
Encephalopathy	27	20.6 14.2–29.9ROR 21.1 · χ² 484 / p 2e-107	20.3 EB05 14.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.4 · 92% clinician	no trial data cached
Generalised tonic-clonic seizure	27	30.8 21.2–44.8ROR 31.6 · χ² 749 / p 3e-165	30.2 EB05 21.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · ♀ 0% (drug 35%) · 100% clinician	no trial data cached
Hypercalcaemia	25	37.9 25.7–55.8ROR 38.7 · χ² 860 / p 2e-189	36.8 EB05 26.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.3 · ♀ 5% (drug 35%) · 92% clinician	no trial data cached
Delirium	24	13.0 8.7–19.3ROR 13.2 · χ² 253 / p 3e-57	12.4 EB05 8.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · ♀ 10% (drug 35%) · 95% clinician	no trial data cached
Disorientation	23	10.8 7.2–16.2ROR 11.0 · χ² 195 / p 1e-44	10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Disturbance in attention	21	7.2 4.7–11.1ROR 7.4 · χ² 107 / p 2e-25	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 95% clinician	no trial data cached
Dysarthria (slurred speech)	20	9.9 6.4–15.3ROR 10.1 · χ² 152 / p 3e-35	8.9 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Completed suicide (death by suicide)	19	4.2 2.7–6.6ROR 4.3 · χ² 44 / p 2e-11	3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 2.7	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.

Hypercalcaemia — n=25, PRR 37.9
Generalised tonic-clonic seizure — n=27, PRR 30.8
Drug-induced liver injury — n=40, PRR 24.2
Encephalopathy — n=27, PRR 20.6
Delirium — n=24, PRR 13.0
Disorientation — n=23, PRR 10.8
Dysarthria — n=20, PRR 9.9
Suicide attempt — n=31, PRR 9.5
Disturbance in attention — n=21, PRR 7.2
Toxicity to various agents — n=64, PRR 7.1

✓ A hand-written Bradford Hill causality assessment exists for this drug: Disulfiram ↔ Drug-induced liver injury.

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 Disulfiram?

In FDA FAERS, the most frequently co-reported reaction terms for Disulfiram are toxicity to various agents, drug-induced liver injury, suicide attempt, psychotic disorder, suicidal ideation, encephalopathy. 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 Disulfiram have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge. The physician should instruct relatives accordingly.

Do FAERS signals prove that Disulfiram 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 40f5497f-fe84-43b2-8ff4-32d59edf3917, effective 20240820; matched on openfda.generic_name.exact:"DISULFIRAM")
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, field patient.drug.openfda.generic_name.exact, 73 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.