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Two medicines, side by side

Azelaic acid vs tretinoin

Azelaic acid and tretinoin are both labeled for acne. Drugs@FDA records approvals of azelaic acid since 1995 and of tretinoin since 1971. Pharmacies paid $0.441 per gram (Azelaic acid 15% gel) and $0.506 per gram (Tretinoin 0.025% cream) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the azelaic acid FDA label on DailyMed (effective November 11, 2021); the tretinoin FDA label on DailyMed (effective May 17, 2024).

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

Highlights of the tretinoin record

Tretinoin (Retin-A) · label of May 17, 2024

Used for

From the label: indications

RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

On the market

Earliest approval on file
October 20, 1971
Generic labelers
23 labelers
Pharmacy cost
$0.506 per gram

Supply and safety

Shortage
No current entry
Recalls
2

Source: FDA drug labels via openFDA (Azelaic acid label of November 11, 2021, Tretinoin label of May 17, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do azelaic acid and tretinoin differ on the record?

Generics: azelaic acid since 2018; tretinoin since 1998 (Drugs@FDA).

Azelaic acidTretinoin
Labeled forAcneAcne
Pharmacologic classn/aRetinoid
How it works (label)The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.n/a
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)September 13, 1995October 20, 1971
First generic approvedNovember 19, 2018June 19, 1998
Generic labelers (NDC)5 labelers23 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.441 per gram (Azelaic acid 15% gel)$0.506 per gram (Tretinoin 0.025% cream)
12-month price change-32%-49%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded32
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)9398,069
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?

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