Drug · FAERS side-effect profile with label screen
Acitretin side effects: what 4,849 FDA adverse event reports show
Who reports
4,849 reports · 86% serious · 277 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids.
FDA label, Indications and Usage
What it is
DESCRIPTION Acitretin, USP, a retinoid, is available in 10-mg, 17.5-mg, and 25-mg gelatin capsules for oral administration.
FDA label, Description section
Boxed warning
CONTRAINDICATIONS AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 4Labeled (related wording) 10Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 23
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 347 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Affect lability | 198 | 90.4 78.8–103.8ROR 94.2 · χ² 17,062 / p <1e-300 | 87.8 EB05 78.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 82.9 · ♀ 100% (drug 50%) · 94% clinician | no trial data cached |
| Motor dysfunction | 196 | 85.4 74.4–98.1ROR 89.0 · χ² 15,959 / p <1e-300 | 83.1 EB05 73.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 70.8 · ♀ 100% (drug 50%) · 94% clinician | no trial data cached |
| Skin haemorrhage | 279 | 85.3 76.0–95.7ROR 90.4 · χ² 22,709 / p <1e-300 | 83.1 EB05 75.3 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=269 · ♀ 91% (drug 50%) | no trial data cached |
| Sinus congestion | 220 | 71.5 62.7–81.4ROR 74.8 · χ² 14,973 / p <1e-300 | 69.9 EB05 62.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=219 · ♀ 99% (drug 50%) · 91% clinician | no trial data cached |
| Muscle spasticity | 198 | 70.2 61.1–80.5ROR 73.1 · χ² 13,218 / p <1e-300 | 68.6 EB05 60.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 66.2 · ♀ 100% (drug 50%) · 93% clinician | no trial data cached |
| Coordination abnormal | 197 | 61.5 53.6–70.6ROR 64.1 · χ² 11,506 / p <1e-300 | 60.3 EB05 53.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 56.4 · ♀ 100% (drug 50%) · 94% clinician | no trial data cached |
| Respiratory tract congestion | 215 | 59.2 51.9–67.6ROR 61.9 · χ² 12,094 / p <1e-300 | 58.2 EB05 51.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 90.7 · ♀ 100% (drug 50%) · 91% clinician | no trial data cached |
| Hemiparesis | 196 | 50.3 43.8–57.7ROR 52.4 · χ² 9,318 / p <1e-300 | 49.5 EB05 43.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 36.1 · ♀ 100% (drug 50%) · 94% clinician | no trial data cached |
| Sinus disorder | 218 | 48.1 42.2–54.8ROR 50.3 · χ² 9,896 / p <1e-300 | 47.3 EB05 42.3 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 68.8 · ♀ 100% (drug 50%) · 93% clinician | no trial data cached |
| Sneezing | 218 | 42.6 37.4–48.5ROR 44.5 · χ² 8,729 / p <1e-300 | 42.0 EB05 37.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 70.7 · ♀ 100% (drug 50%) · 92% clinician | no trial data cached |
| Eating disorder | 195 | 39.8 34.7–45.7ROR 41.4 · χ² 7,278 / p <1e-300 | 39.3 EB05 34.9 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 36.9 · ♀ 99% (drug 50%) · 93% clinician | no trial data cached |
| Psoriasis | 1,184 | 39.5 37.6–41.5ROR 52.0 · χ² 44,278 / p <1e-300 | 39.1 EB05 37.3 · IC025 +5.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 66.3 | no trial data cached |
| Squamous cell carcinoma | 68 | 31.4 24.8–39.8ROR 31.9 · χ² 1,959 / p <1e-300 | 31.0 EB05 25.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 94% clinician | no trial data cached |
| Psoriatic arthropathy | 285 | 30.9 27.6–34.6ROR 32.7 · χ² 8,160 / p <1e-300 | 30.6 EB05 27.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.6 | no trial data cached |
| Angina pectoris | 202 | 30.5 26.6–34.9ROR 31.8 · χ² 5,699 / p <1e-300 | 30.2 EB05 26.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.0 · ♀ 99% (drug 50%) · 90% clinician | no trial data cached |
| Aphasia (loss of speech) | 205 | 29.5 25.8–33.7ROR 30.7 · χ² 5,579 / p <1e-300 | 29.2 EB05 26.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 · ♀ 96% (drug 50%) · 93% clinician | no trial data cached |
| Cystitis | 212 | 28.9 25.3–32.9ROR 30.1 · χ² 5,646 / p <1e-300 | 28.6 EB05 25.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 · ♀ 99% (drug 50%) · 92% clinician | no trial data cached |
| Dysarthria (slurred speech) | 200 | 23.1 20.2–26.5ROR 24.1 · χ² 4,193 / p <1e-300 | 22.9 EB05 20.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · ♀ 99% (drug 50%) · 94% clinician | no trial data cached |
| Skin exfoliation | 372 | 19.4 17.6–21.4ROR 21.0 · χ² 6,485 / p <1e-300 | 19.3 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.3 · ♀ 82% (drug 50%) | no trial data cached |
| Pain of skin | 109 | 17.5 14.5–21.1ROR 17.9 · χ² 1,677 / p <1e-300 | 17.4 EB05 14.8 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 44.0 | no trial data cached |
| Rhinorrhoea (runny nose) | 258 | 17.4 15.4–19.6ROR 18.3 · χ² 3,962 / p <1e-300 | 17.3 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 · ♀ 95% (drug 50%) | no trial data cached |
| Candida infection (yeast infection) | 62 | 16.1 12.6–20.7ROR 16.3 · χ² 862 / p 9e-190 | 16.0 EB05 12.9 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.0 · ♀ 24% (drug 50%) | no trial data cached |
| Oral candidiasis (oral thrush) | 46 | 15.3 11.5–20.5ROR 15.5 · χ² 601 / p 6e-133 | 15.1 EB05 11.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Cataract | 201 | 14.7 12.8–16.8ROR 15.3 · χ² 2,552 / p <1e-300 | 14.6 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · ♀ 95% (drug 50%) | no trial data cached |
| Arthritis | 264 | 14.5 12.9–16.3ROR 15.3 · χ² 3,315 / p <1e-300 | 14.5 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 · ♀ 90% (drug 50%) | no trial data cached |
| Hypercholesterolaemia | 30 | 13.6 9.5–19.4ROR 13.7 · χ² 337 / p 2e-75 | 13.2 EB05 9.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 20% (drug 50%) · 90% clinician | no trial data cached |
| Scratch | 31 | 13.0 9.1–18.5ROR 13.1 · χ² 330 / p 4e-74 | 12.5 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 81% (drug 50%) | no trial data cached |
| Skin infection | 33 | 12.8 9.1–18.0ROR 12.9 · χ² 347 / p 9e-78 | 12.4 EB05 9.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · ♀ 78% (drug 50%) | no trial data cached |
| Skin lesion | 80 | 12.7 10.2–15.8ROR 12.9 · χ² 852 / p 1e-187 | 12.6 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Inflammatory bowel disease | 28 | 12.3 8.5–17.9ROR 12.4 · χ² 280 / p 4e-63 | 11.8 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 92% (drug 50%) · 100% clinician | no trial data cached |
| Skin fissures | 52 | 11.9 9.1–15.7ROR 12.1 · χ² 509 / p 4e-113 | 11.6 EB05 9.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=35 | no trial data cached |
| Synovitis | 49 | 11.8 8.9–15.6ROR 11.9 · χ² 471 / p 9e-105 | 11.4 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Brain oedema | 33 | 11.3 8.1–15.9ROR 11.4 · χ² 300 / p 2e-67 | 10.8 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 0% (drug 50%) | no trial data cached |
| Influenza like illness (flu-like illness) | 215 | 11.3 9.9–12.9ROR 11.8 · χ² 2,006 / p <1e-300 | 11.2 EB05 10.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 98% (drug 50%) · 90% clinician | no trial data cached |
| Vaginal discharge | 26 | 11.2 7.6–16.5ROR 11.3 · χ² 231 / p 1e-52 | 10.5 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Influenza | 284 | 11.0 9.8–12.3ROR 11.6 · χ² 2,581 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 · ♀ 84% (drug 50%) | no trial data cached |
| Therapeutic product effect incomplete | 179 | 11.0 9.5–12.7ROR 11.4 · χ² 1,614 / p <1e-300 | 10.9 EB05 9.6 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
| Gastrointestinal disorder | 223 | 10.9 9.6–12.4ROR 11.4 · χ² 2,006 / p <1e-300 | 10.8 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · ♀ 82% (drug 50%) | no trial data cached |
| Transaminases increased | 56 | 10.9 8.4–14.2ROR 11.0 · χ² 494 / p 8e-110 | 10.6 EB05 8.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · 96% clinician | no trial data cached |
| Localised infection | 61 | 10.9 8.5–14.0ROR 11.1 · χ² 539 / p 1e-119 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 · ♀ 29% (drug 50%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Psoriasis | 1,184 | 39.5 37.6–41.5ROR 52.0 · χ² 44,278 / p <1e-300 | 39.1 EB05 37.3 · IC025 +5.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 66.3 | no trial data cached |
| Drug ineffective (drug did not work) | 1,170 | 3.8 3.7–4.0ROR 4.8 · χ² 2,623 / p <1e-300 | 3.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Pain | 490 | 3.4 3.2–3.7ROR 3.7 · χ² 873 / p 3e-192 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · ♀ 76% (drug 50%) | no trial data cached |
| Fatigue (tiredness) | 483 | 2.7 2.5–2.9ROR 2.9 · χ² 530 / p 1e-117 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 79% (drug 50%) | no trial data cached |
| Off label use (used outside approved label) | 476 | 2.4 2.2–2.6ROR 2.5 · χ² 393 / p 1e-87 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Nausea | 441 | 2.4 2.2–2.6ROR 2.6 · χ² 379 / p 8e-85 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · ♀ 78% (drug 50%) | no trial data cached |
| Pruritus (itching) | 441 | 5.1 4.6–5.5ROR 5.5 · χ² 1,453 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Headache | 372 | 2.6 2.3–2.8ROR 2.7 · χ² 366 / p 7e-82 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · ♀ 93% (drug 50%) | no trial data cached |
| Skin exfoliation | 372 | 19.4 17.6–21.4ROR 21.0 · χ² 6,485 / p <1e-300 | 19.3 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.3 · ♀ 82% (drug 50%) | no trial data cached |
| Pneumonia (lung infection) | 357 | 4.8 4.3–5.3ROR 5.1 · χ² 1,079 / p 6e-237 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · ♀ 85% (drug 50%) | no trial data cached |
| Pyrexia (fever) | 347 | 4.3 3.9–4.8ROR 4.6 · χ² 902 / p 2e-198 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · ♀ 83% (drug 50%) | no trial data cached |
| Malaise (feeling unwell) | 345 | 3.4 3.1–3.8ROR 3.6 · χ² 593 / p 3e-131 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · ♀ 85% (drug 50%) | no trial data cached |
| Nasopharyngitis (common cold) | 316 | 7.4 6.7–8.2ROR 7.9 · χ² 1,758 / p <1e-300 | 7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 83% (drug 50%) | no trial data cached |
| Cough | 310 | 4.8 4.3–5.3ROR 5.1 · χ² 939 / p 2e-206 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 86% (drug 50%) | no trial data cached |
| Vomiting | 289 | 2.7 2.4–3.0ROR 2.8 · χ² 306 / p 8e-69 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · ♀ 91% (drug 50%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Affect lability — n=198, PRR 90.4
- Motor dysfunction — n=196, PRR 85.4
- Sinus congestion — n=220, PRR 71.5
- Muscle spasticity — n=198, PRR 70.2
- Coordination abnormal — n=197, PRR 61.5
- Respiratory tract congestion — n=215, PRR 59.2
- Hemiparesis — n=196, PRR 50.3
- Sneezing — n=218, PRR 42.6
- Squamous cell carcinoma — n=68, PRR 31.4
- Angina pectoris — n=202, PRR 30.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Acitretin?
In FDA FAERS, the most frequently co-reported reaction terms for Acitretin are psoriasis, pain, fatigue, nausea, pruritus, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Acitretin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CONTRAINDICATIONS AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy.
Do FAERS signals prove that Acitretin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 6af396c2-af3e-436d-ba9a-583637495910, effective 20240109; matched on
openfda.generic_name.exact:"ACITRETIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 387 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.