Drug Safety Information for DAPSONE (Dapsone)

Safety-related Labeling Changes for ACZONE (DAPSONE) Rx Drug: FDA Link

Adverse Drug Reactions for DAPSONE* (Dapsone)

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 DAPSONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia147
2Nausea143
3Diarrhoea*140
4Anaemia139
5Drug ineffective136
6Dyspnoea126
7Pneumonia115
8Asthenia102
9Fatigue96
10Rash89
11Vomiting89
12Erythema85
13Methaemoglobinaemia83
14Renal failure acute82
15Headache81
16Pancytopenia80
17Renal failure79
18Oedema peripheral74
19Thrombocytopenia69
20Pain68

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

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

Reason # of FDA Reports
1Product used for unknown indication1278
2Acne*601
3Antifungal prophylaxis376
4Prophylaxis326
5Infection prophylaxis231
6Leprosy190
7Pneumocystis jiroveci pneumonia151
8Antibiotic prophylaxis134
9Dermatitis herpetiformis*125
10Hiv infection89

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


Types of Adverse Events for DAPSONE

Total Reports Filed with FDA: 13016


Number of FDA Adverse Event Reports by Patient Age for DAPSONE

Total Reports Filed with FDA: 13016*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dapsone (Sulfona, Disulone, Aczone, Dapsone)

Charts are based on 13016 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 DAPSONE 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.