FDA-approved drug
Dapsone is one molecule living two lives, about one hundred times apart
The same sulfone is a monitored systemic drug and a gentle acne gel, and the crossover study measured the distance between those lives: a day of maximal gel use put 415 ng.h/mL of dapsone into the blood; one 100 mg tablet put in 52,641. On the oral side sit dermatitis herpetiformis and leprosy, a blood-count calendar, and hemolysis in almost all patients. On the topical side sit acne trials of 7,300-plus patients with side effects nearly identical to the vehicle gel, honestly modest results (about 30% clear-or-minimal skin versus 21% on vehicle), and a label that dropped its G6PD testing requirement in 2008 when route-specific data arrived. Every study row below is labeled by species and by route, so neither life borrows the other's story.
- 26studies and evidence sources in our graded table
- 24of them human evidence, species-labeled row by row
- 11topical-route human rows and 11 oral-route human rows, plus the one crossover study that measured both routes at once
- 44fetch-verified citations, 100.0% peer-reviewed or government sources
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Key facts
- StatusFDA-approved drug
- Topical Cmax (7.5%, steady state)13.0 ng/mL
- Topical AUC(0-24) (7.5%)282 ng.h/mL
- Topical AUC(0-24) (5% BID, day 14)415 ng.h/mL
- Oral AUC (single 100 mg)52,641 ng.h/mL
- Oral vs topical exposureAbout 100x (label: gel is about 1% of oral)
- Oral Tmax4 to 8 hours
- Topical steady stateReached within 7 days
- Oral urinary recoveryAbout 85% of daily intake (as metabolites)
- ClassSulfone (4,4'-diaminodiphenyl sulfone, DDS); antimicrobial plus anti-inflammatory
- Molecular weight248.30 Da (C12H12N2O2S)
- Route divideGel exposure is about 1% of a 100 mg oral dose (AUC 282 to 415 vs 52,641 ng.h/mL)
- Oral half-life10 to 50 hours, average 28
- Oral hemolysisDose-related, near-universal: 1 to 2 g hemoglobin loss in almost all patients
- Hypersensitivity syndrome1.4% of oral-treated patients; 9.9% fatality when it occurs
- G6PD testingOral: caution and monitoring. Topical: not required (screening requirement removed from the label in 2008)
- Study rows on this site26 (24 human, 1 in vitro, 1 animal), every row species- and route-labeled
- Verified citations44 (100.0% peer-reviewed or government)
Browse by topic
Everything on Dapsone for skin, organized the way you research it.
Free Dapsone tools
Practical calculators and references, each scoped and sourced.
Review-gated tools: these tools are excluded from search and AI citation and must not be used as medication, monitoring, or treatment instruction.
All guides
50 in-depth, individually cited guides.
Review-gated archive: the guides below are preserved for individual medical and source review. They are excluded from search indexing and AI citation files.
Safety 17 guides
Evidence 12 guides
Sourcing 8 guides
Dosing 8 guides
Comparisons 5 guides
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