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Dapsone

Acnewell, Vulgarex · ATC code D10AX05

Also known as: Dapson · Brand names: Dapson-Fatol, Dapson Zentiva, Acnewell, Vulgarex, Aczone

Key facts
Active substance
Dapsone
ATC code
D10AX05
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Dapsone is, per the US prescribing information, a sulfone that is bactericidal and bacteriostatic against Mycobacterium leprae, used for dermatitis herpetiformis and leprosy.

What it is used for

  • Dermatitis herpetiformis.
  • All forms of leprosy except cases of proven dapsone resistance.

Dosing

  • Dermatitis herpetiformis: adults start with 50 mg daily, children with correspondingly smaller doses; titrate individually, and if control is not achieved within 50 to 300 mg daily, higher doses may be tried; reduce to a minimum maintenance level as soon as possible.
  • A strict gluten-free diet may allow the dose to be reduced or dapsone to be stopped.
  • Leprosy: in combination with one or more other anti-leprosy drugs, 100 mg daily without interruption (smaller doses for children), e.g. with rifampin; duration depends on the form of leprosy – see the full text.
  • Acetylation rate influences dapsone levels and may require a dose adjustment.

Contraindications

  • Hypersensitivity to dapsone and/or its derivatives.

Important warnings

  • Deaths from agranulocytosis, aplastic anemia and other blood dyscrasias have been reported; when feasible, check blood counts weekly for the first month, monthly for six months and semiannually thereafter.
  • Patients should respond to sore throat, fever, pallor, purpura or jaundice.
  • Hemolysis and methemoglobin formation, exaggerated in G6PD deficiency, methemoglobin reductase deficiency or hemoglobin M; treat severe anemia before starting.
  • Severe cutaneous reactions (including exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis) are rare but among the most serious complications.
  • Toxic hepatitis and cholestatic jaundice early in therapy; monitor liver function when feasible.
  • Falsely reduced HbA1c may occur; use alternate measures of glycemic control.

Side effects

  • Most common: dose-related hemolysis, with or without G6PD deficiency; almost all patients show a hemoglobin loss of 1 to 2g, a rise in reticulocytes and in methemoglobin.
  • Peripheral neuropathy (mainly motor), particularly in non-leprosy patients.
  • Others: nausea, vomiting, abdominal pain, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity.

Interactions

  • Rifampin lowers dapsone levels 7 to 10-fold; in leprosy no dose change has been required.
  • Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions.
  • Trimethoprim: a modest mutual increase in levels has been reported.

Pregnancy and breastfeeding

  • Extensive but uncontrolled experience has not shown an increased risk of fetal abnormalities.
  • Dapsone is excreted in breast milk in substantial amounts; hemolytic reactions can occur in neonates.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • Dapson-FatolEsteve Pharmaceuticals Gmbh · 1 register entry
  • Dapson ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AcnewellİLKO İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
  • VulgarexFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AczoneAlmirall, LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 6 more European countries
Denmark
Dapson Scanpharm
Malta
Dapsone Tillomed Laboratories
Netherlands
Dapson Tiofarma
Norway
Dapson Scanpharm
Poland
Dusalm
Portugal
Sulfona Zimaia

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Dapsone (Macleods Pharmaceuticals Limited) – Prescribing Information, 2026-07-20. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=839d7440-ba0e-4c56-b648-d374b155cf03
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.