Tretinoin

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Tretinoin
Generic name
TRETINOIN
Manufacturer
Actavis Pharma, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
b5e385a2-f6f9-41cb-8a33-eedba397043f
SPL ID
b99bedbe-3d36-47dd-b84c-05f8bb394b83
Version
16
Effective date
2024-12-11
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:36
Harmonized routes table
Harmonized routes
TOPICAL

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication dosing frequency should be adjusted temporarily to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin cream. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin cream. Adverse effects of tretinoin cream have been reversible upon discontinuation of therapy (see DOSAGE AND ADMINISTRATION section).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.