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Two medicines, side by side

Dapsone vs azelaic acid

Dapsone and azelaic acid are both labeled for acne. Drugs@FDA records approvals of dapsone since 2005 and of azelaic acid since 1995. Pharmacies paid $0.664 per gram (Dapsone 5% gel) and $0.441 per gram (Azelaic acid 15% gel) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the dapsone FDA label on DailyMed (effective July 20, 2026); the azelaic acid FDA label on DailyMed (effective November 11, 2021).

Highlights of the dapsone record

Dapsone (Aczone) · label of July 20, 2026

Used for

From the label: indications

Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven dapsone resistance.

On the market

Earliest approval on file
July 7, 2005
Generic labelers
27 labelers
Pharmacy cost
$0.664 per gram

Supply and safety

Shortage
A presentation being discontinued
Recalls
4

Highlights of the azelaic acid record

Azelaic acid (Finacea) · label of November 11, 2021

Used for

From the label: indications

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. […]

On the market

Earliest approval on file
September 13, 1995
Generic labelers
5 labelers
Pharmacy cost
$0.441 per gram

Supply and safety

Shortage
No current entry
Recalls
3

Source: FDA drug labels via openFDA (Dapsone label of July 20, 2026, Azelaic acid label of November 11, 2021); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do dapsone and azelaic acid differ on the record?

How each works, in its label's words: Dapsone, “in Dermatitis herpetiformis has not been established.”; Azelaic acid, “The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.”

Generics: dapsone since 1979; azelaic acid since 2018 (Drugs@FDA).

DapsoneAzelaic acid
Labeled forAcneAcne
Pharmacologic classSulfonen/a
How it works (label)in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)July 7, 2005September 13, 1995
First generic approvedJuly 3, 1979November 19, 2018
Generic labelers (NDC)27 labelers5 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.664 per gram (Dapsone 5% gel)$0.441 per gram (Azelaic acid 15% gel)
12-month price change-36%-32%
Boxed warningNoNo
Shortage nowA presentation being discontinuedNo current entry
Recalls recorded43
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)10,643939
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

Alternatives to dapsone
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