Drug Safety Information for DISULFIRAM (Disulfiram)

Adverse Drug Reactions for DISULFIRAM* (Disulfiram)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with DISULFIRAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction80
2Confusional state53
3Nausea38
4Overdose37
5Anxiety*35
6Toxicity to various agents34
7Malaise34
8Asthenia34
9Alanine aminotransferase increased33
10Vomiting32
11Agitation31
12Hypotension30
13Insomnia30
14Gait disturbance29
15Psychotic disorder28
16Aspartate aminotransferase increased27
17Somnolence27
18Fatigue25
19Memory impairment25
20Dizziness24

* This side effect also appears in "Top 10 Side Effects of DISULFIRAM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DISULFIRAM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Alcoholism670
2Product used for unknown indication390
3Alcohol abuse322
4Alcohol use75
5Alcohol detoxification60
6Drug dependence30
7Abstains from alcohol22
8Alcohol rehabilitation22
9Aversion21
10Alcohol withdrawal syndrome19

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for DISULFIRAM

Total Reports Filed with FDA: 3933


Number of FDA Adverse Event Reports by Patient Age for DISULFIRAM

Total Reports Filed with FDA: 3933*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Disulfiram (Disulfiram, Refusal, Esperal, Disulfiram , Antabuse)

Charts are based on 3933 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and DISULFIRAM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.