This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Tretinoin Gel is indicated for topical treatment of acne vulgaris. Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )
None. None ( 4 )
• Tretinoin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 ) • Topical over-the-counter acne preparations, concomitant topical medications, medicated cleansers, topical products with alcohol or astringents: Use with caution, irritation may occur. ( 5.1 ) • Avoid unprotected exposure to sunlight including sunlamps (UV light) when using Tretinoin Gel due to potential for increased photosensitization. Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) • Avoid use of Tretinoin Gel with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) • Use Tretinoin Gel with caution if allergic to fish due to potential for allergenicity to fish protein. Patients who develop pruritus or urticaria should contact their healthcare provider. ( 5.3 ) 5.1 Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Tretinoin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduce...
The most common adverse reactions (incidence ≥5%) with Tretinoin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under prescribing conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies (14) ] .In these studies, 50% of the subjects who were treated with Tretinoin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse r...
Source: FDA SPL label for Tretinoin (Obagi Cosmeceuticals LLC), effective 20210501. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 649 | 634 | 609 | 613 | 690 | 793 | 914 | 419 |
7,910 reports blaming this drug for every million Medicare prescriptions filled, which is 2.9× the typical drug on this site. (2,122 reports in 2024–2026, against 268,282 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 09/2026 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications |
| 09/2026 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications |
| 09/2026 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $2,158 in payments to US physicians and hospitals tied to this drug across 5 transactions (Altreno $2,158).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Tretinoin | 235,091 | $90 |
| Retin-A | 32,166 | $31 |
| Altreno | 1,009 | $91 |
| Atralin | 16 | $557 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.