What the label lists and what reports show
Tretinoin side effects
Tretinoin's FDA label lists its adverse reactions in its own words. FAERS holds 8,069 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (585 reports).
- Generic listed
Check it at the source: the tretinoin FDA label on DailyMed (effective May 17, 2024, Bausch Health US, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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 should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of RETIN-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. To date, all adverse effects of RETIN-A have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in at Least 1% of Subjects)
This table is printed in the Tretinoin label published by Oceanside Pharmaceuticals of February 1, 2024; the label quoted above does not print one.
| Event | Tretinoin Gel (N = 674) | Vehicle (N = 487) |
|---|---|---|
| Dry Skin | 109 (16%) | 8 (2%) |
| Peeling/Scaling/Flaking Skin | 78 (12%) | 7 (1%) |
| Skin Burning Sensation | 53 (8%) | 8 (2%) |
| Erythema | 47 (7%) | 1 (<1%) |
| Pruritus | 11 (2%) | 3 (1%) |
| Pain of Skin | 7 (1%) | 0 (0%) |
| Sunburn | 7 (1%) | 3 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Bausch Health US, LLC, effective May 17, 2024 (SPL set 9556d73d-c573-4e0a-9feb-764ce2d1107b), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,069 reports list tretinoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 864 are coded as a death and 1,669 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tretinoin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions