Dapsone
Active ingredient · 2 therapeutic classes
Sold as ACZONE
- Drug class
- Drugs For Treatment Of Lepra
- Availability
- Prescription only
- Routes
- Oral, Topical
- Markets covered
- 3
- Products on record
- 18
- FDA reports (12 mo)
- 756
Overview
Plain-language summary, compiled from the cited regulatory records
Dapsone is a medication classified as an "Other Anti-Acne Preparation for Topical Use" [1]. It is approved for the treatment of dermatitis herpetiformis and all forms of leprosy, excluding cases where dapsone resistance has been confirmed [1].
In the past 12 months, there have been 756 adverse event reports associated with dapsone [2]. Among the top reported reactions were off-label use, methaemoglobinaemia, the drug being ineffective, drug reaction with eosinophilia and systemic symptoms (DRESS), and issues related to product dose omission [2]. Dapsone is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 14 | May 15, 2026 |
| US United States | FDA | 1 | January 13, 2026 |
| CA Canada | Health Canada | 3 | March 22, 2025 |
GBUnited Kingdom· MHRA
14 products
Uses
1) As part of multi-drug regimen in the treatment of all forms of leprosy. 2) Treatment of dermatitis herpetiformis and other dermatoses. 3) Prophylaxis of malaria in combination with pyrimethamine. 4) Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients.
How to take
USUnited States· FDA
1 product
Uses
INDICATIONS AND USAGE
) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
How to take
CACanada· Health Canada
3 products
3 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
Drug interactions
Known interactions involving Dapsone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 358. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL347710301 · revised November 15, 2024
- [2]FDA DailyMed · 13002250-b4c5-58… · revised January 13, 2026 [PDF]
- [3]Health Canada (DPD) · 02281074 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.