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What the label lists and what reports show

Disulfiram side effects

Disulfiram's FDA label lists its adverse reactions in its own words. FAERS holds 1,124 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (83 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the disulfiram FDA label on DailyMed (effective August 20, 2024, Sigmapharm Laboratories, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

(See CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS .) OPTIC NEURITIS, PERIPHERAL NEURITIS, POLYNEURITIS, AND PERIPHERAL NEUROPATHY MAY OCCUR FOLLOWING ADMINISTRATION OF DISULFIRAM. Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram. Occasional skin eruptions are, as a rule, readily controlled by concomitant administration of an antihistaminic drug. In a small number of patients, a transient mild drowsiness, fatigability, impotence, headache, acneform eruptions, allergic dermatitis, or a metallic or garlic-like aftertaste may be experienced during the first two weeks of therapy. These complaints usually disappear spontaneously with the continuation of therapy, or with reduced dosage. …

Source: FDA drug label, Sigmapharm Laboratories, LLC, effective August 20, 2024 (SPL set 40f5497f-fe84-43b2-8ff4-32d59edf3917), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,124 reports list disulfiram among the medicines taken, each a report of something that happened, not proof the medicine caused it; 113 are coded as a death and 531 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)124
  • Drug Interaction (a use or a product term, not a reaction)122
  • Fatigue (named in the label)83
  • Drug Ineffective (a use or a product term, not a reaction)67
  • Toxicity To Various Agents64
  • Nausea (named in the label)52
  • Confusional State48
  • Drug Abuse44
  • Psychiatric Symptom44
  • Anxiety43
  • Overdose (a use or a product term, not a reaction)43
  • Drug-Induced Liver Injury40
  • Condition Aggravated (a use or a product term, not a reaction)36
  • Somnolence36
  • Toxic Encephalopathy36
  • Vomiting (named in the label)34
  • Acute Kidney Injury33
  • Malaise (named in the label)33
  • Neuropathy Peripheral33
  • Insomnia32
  • Tremor32
  • Asthenia31
  • Suicide Attempt31
  • Psychotic Disorder30
  • Suicidal Ideation28

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Disulfiram: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions