Dapsone: uses, dosing, side effects & brands
Dapsone is a sulfone sold in the U.S. under one brand, for dermatitis herpetiformis, relapsing polychondritis and lepromatous leprosy. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Sulfone
- Treats
- Dermatitis Herpetiformis, Relapsing Polychondritis and Lepromatous Leprosy
- Available as
- Topical
- Sold as
- Aczone
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $24 for a 30-count supply — not your price
How dapsone is dosed
From the FDA label for Aczone (application NDA207154). Other dapsone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For topical use only. Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas once daily. Rub in ACZONE Gel, 7.5%, gently and completely. If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed. Apply once daily ( 2 ). Apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face. A thin layer can also be applied to other affected areas ( 2 ). If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed ( 2 ). For topical use only. Not for oral, ophthalmic, or intravaginal use ( 2 ).
Dapsone side effects
Most common (incidence ≥ 0.9%) adverse reactions are application site dryness and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2161 subjects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% Caucasian. Adverse drug reactions that were reported in at least 0.9% of subjects treated with ACZONE Gel, 7.5% appear in Table 1 below. Table 1. Adverse Reactions Occurring in at Least 0.9% of Subjects with Acne Vulgaris in 12-week Controlled Clinical Trials ACZONE Gel, 7.5% (N=2161) Vehicle (N=2175) Application Site Dryness 24 (1.1%) 21 (1.0%) Application Site Pruritus 20 (0.9%) 11 (0.5%) 6.2 Experience with Oral Use of Dapsone Although not observed in the clinical trials with topical dapsone, serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions…
Who shouldn’t take dapsone
None. None ( 4 ).
Dapsone drug interactions
No formal drug-drug interaction studies were conducted with ACZONE Gel, 7.5%. Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites ( 7.1 ). Topical benzoyl peroxide used at the same time as ACZONE Gel, 7.5% may result in temporary local yellow or orange skin discoloration ( 7.2 ). 7.1 Trimethoprim-Sulfamethoxazole A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5% in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased in the presence of TMP/SMX. The systemic exposure from ACZONE Gel, 7.5% is expected to be about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX. 7.2 Topical Benzoyl Peroxide Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair. 7.3 Drug Interactions with Oral Dapsone Certain concomitant medications (such as rifampin, anticonvulsants, St. John’s wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions. 7.4 Concomitant Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )] .
Every dapsone product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Aczone.
What dapsone pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Dapsone recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long dapsone keeps
No dapsone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does dapsone expire? The in-use limits and storage rules from its labelsDapsone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dapsone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadDapsone can be used during breastfeeding; however, hemolytic anemia might occur, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth. One source states that use of dapsone in the treatment of leprosy is advantageous because it kills the organisms in breastmilk. Monitor the infant for signs of hemolysis, especially in newborn or premature breastfed infants.
National Institute of Child Health and Human Development, record revised September 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dapsone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 9,797 reports naming dapsone, and the FDA flagged 81% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- methaemoglobinaemia482 reports
- pyrexia459 reports
- fatigue455 reports
- nausea454 reports
- diarrhoea407 reports
- pneumonia387 reports
- dyspnoea375 reports
- drug reaction with eosinophilia and systemic symptoms370 reports
Read these as a signal, not a rate. A report does not mean dapsone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is dapsone?
Aczone (Dapsone) is a sulfone used to treat Dermatitis Herpetiformis, Relapsing Polychondritis, Lepromatous Leprosy, Aids-Related Opportunistic Infections.
What kind of drug is dapsone?
The FDA classifies dapsone as a sulfone. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dapsone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dapsone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does dapsone come in?
Across the brands we track, dapsone is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dapsone?
We do not currently list a generic-labelled dapsone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has dapsone been recalled?
The FDA's Enforcement database lists 4 recall records whose product description mentions dapsone. The most recent: Dapsone Gel 7.5% (Dec 10, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dapsone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dapsone
- MLA
- “Dapsone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dapsone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dapsone on DailyMed (NIH) ↗.