What the label lists and what reports show
Acitretin side effects
Acitretin's FDA label lists its adverse reactions in its own words. FAERS holds 4,849 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 (490 reports).
- Generic listed
- Boxed warning
Check it at the source: the acitretin FDA label on DailyMed (effective August 5, 2026, Sigmapharm Laboratories, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of acitretin capsules?Acitretin capsules can cause serious side effects, including: See “What is the most important information I should know about acitretin capsules?” and “What are the important warnings and instructions for females taking acitretin capsules?” Stop taking acitretin capsules and call your prescriber right away if you get the following signs or symptoms of possible serious side effects: Bad headaches, nausea, vomiting, blurred vision. These symptoms can be signs of increased brain pressure that can lead to blindness or even death. Vision problems. Decreased vision in the dark (night blindness). Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin capsules stops. Stop taking acitretin capsules and call your prescriber if you develop any vision problems or eye pain. Depression. […]
Source: FDA drug label, Sigmapharm Laboratories, LLC, effective August 5, 2026 (SPL set a6546625-acb8-460e-b34e-f795bfb3680a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsHypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome. Adverse Events/Postmarketing Reports: In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Acute myocardial infarction, thromboembolism (see WARNINGS ), stroke. Immune System Disorders: Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS ). …
Source: FDA drug label, Sigmapharm Laboratories, LLC, effective August 5, 2026 (SPL set a6546625-acb8-460e-b34e-f795bfb3680a), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,849 reports list acitretin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 277 are coded as a death and 1,404 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 22 reactions below, 11 are 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?
- Acitretin: 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