Aczone (Dapsone Gel) During Pregnancy

What does the evidence say about aczone during pregnancy?

1. Topical dapsone gel for acne, used at 5 percent or 7.5 percent concentrations, results in systemic exposure roughly 100 times lower than oral dapsone. 1
2. Systemic absorption from the topical gel is expected to be about 1 percent of what a 100 mg oral dose of dapsone would produce. 2
3. A review of acne management in pregnancy notes that topical dapsone is relatively new and doesn't have the decades of pregnancy safety data that older options like azelaic acid or benzoyl peroxide do, though no clear link to birth defects has been reported and its systemic absorption is low. 3
4. In pregnant women who take oral dapsone for leprosy, a different and much higher-dose use than topical acne gel, the drug is well known to occasionally cause hematologic reactions like hemolytic anemia, which is why any dapsone use in pregnancy is generally paired with monitoring. 4
5. Even though topical dapsone gel results in minimal systemic absorption, the manufacturer states it should not be used while nursing, and until more data are available, an alternative topical option might be preferred for a breastfeeding mother. 2

Is aczone safe in each trimester?

• First trimester. Little dedicated safety data exists for topical dapsone gel in early pregnancy specifically, though its systemic absorption is low. Older options like azelaic acid or benzoyl peroxide have more established pregnancy safety records if you're weighing alternatives with your provider.
• Second trimester. If Aczone was already working well for you, there's no clear signal of a birth-defect risk in what's been reported, but the manufacturer's own guidance is to use it in pregnancy only when the benefit outweighs the risk.
• Third trimester. There's no specific third-trimester guidance for topical dapsone gel beyond the general recommendation to use it only if needed, so this is a good point to confirm with your provider whether to continue it or switch to a better-studied option through delivery.