What the label lists and what reports show
Alitretinoin side effects
Alitretinoin's FDA label: “Most common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders.” FAERS holds 117 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 drug intolerance (9 reports).
- No generic listed
Check it at the source: the alitretinoin FDA label on DailyMed (effective November 25, 2025, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | PANRETIN GEL N=134 % | Vehicle Gel N=134 % | PANRETIN GEL N=36 % | Vehicle Gel N=46 % |
|---|---|---|---|---|
| Rash 1 | 77 | 11 | 25 | 4 |
| Pain 2 | 34 | 7 | 0 | 4 |
| Pruritus 3 | 11 | 4 | 8 | 4 |
| Exfoliative dermatitis 4 | 9 | 2 | 3 | 0 |
| Skin disorder 5 | 8 | 1 | 0 | 0 |
| Edema 6 | 8 | 3 | 3 | 0 |
| Parethesia 7 | 3 | 0 | 22 | 7 |
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.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Photosensitivity [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying 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. The safety of PANRETIN GEL was assessed in two multicenter, prospective, randomized, double-blind, vehicle-controlled trials (Trial 1 and Trial 2) in patients with cutaneous lesions of AIDS-related KS [see Clinical Studies ( 14.1 )]. In a pooled analysis of both trials, the most common adverse reactions in ≥ 5% of patients were rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorder. In Trial 1, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 10% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control). …
Source: FDA drug label, Advanz Pharma (US) Corp., effective November 25, 2025 (SPL set 49c16717-7d86-4257-80c9-baa1417e5555), via openFDA; the full label on DailyMed
What do FAERS reports show?
117 reports list alitretinoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 27 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 19 reactions below, 1 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.
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?
- Alitretinoin: 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