Bexarotene side effects: what 1,309 FDA adverse event reports show
Who reports
1,309 reports · 75% serious · 247 with death outcome · 42% female
Used for
Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Bexarotene is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )
What it is
Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs).
Boxed warning
BIRTH DEFECTS Bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. Bexarotene capsules must not be administered to a pregnant woman. ( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning.
Causality screen of the 30 strongest signals
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 8 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypothyroidism | 75 | 37.8 30.3–47.1ROR 40.1 · χ² 2,649 / p <1e-300 | 37.4 EB05 30.8 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 29.6 · 94% clinician | no trial data cached |
| Blood triglycerides increased | 25 | 22.6 15.3–33.4ROR 23.0 · χ² 495 / p 6e-110 | 22.2 EB05 15.8 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 18.5 | no trial data cached |
| Hypercholesterolaemia | 11 | 18.4 10.2–33.2ROR 18.6 · χ² 164 / p 7e-38 | 17.3 EB05 9.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Hepatic cytolysis | 13 | 17.1 9.9–29.3ROR 17.2 · χ² 181 / p 2e-41 | 16.1 EB05 9.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Hyperlipidaemia | 10 | 13.4 7.2–24.8ROR 13.5 · χ² 102 / p 2e-24 | 11.5 EB05 5.7 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.2 | no trial data cached |
| Adrenal insufficiency | 9 | 12.1 6.3–23.1ROR 12.1 · χ² 80 / p 1e-19 | 9.7 EB05 4.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Skin infection | 7 | 10.1 4.8–21.0ROR 10.1 · χ² 48 / p 2e-12 | 7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Therapy change | 6 | 10.0 4.5–22.2ROR 10.0 · χ² 40 / p 1e-10 | 6.8 EB05 3.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Skin lesion | 16 | 9.4 5.8–15.3ROR 9.5 · χ² 112 / p 2e-26 | 8.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Lymphopenia | 8 | 9.1 4.6–18.2ROR 9.2 · χ² 50 / p 8e-13 | 6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.5 | no trial data cached |
| Blood cholesterol increased | 26 | 8.9 6.1–13.1ROR 9.1 · χ² 176 / p 2e-40 | 8.1 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.6 | no trial data cached |
| Multiple organ dysfunction syndrome | 15 | 8.6 5.2–14.2ROR 8.7 · χ² 94 / p 2e-22 | 7.3 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Drug eruption | 9 | 8.2 4.3–15.7ROR 8.2 · χ² 50 / p 8e-13 | 6.2 EB05 3.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Application site pain | 11 | 8.0 4.4–14.4ROR 8.1 · χ² 61 / p 3e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Disease progression | 57 | 7.7 6.0–10.0ROR 8.1 · χ² 330 / p 5e-74 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 94% clinician | no trial data cached |
| Application site irritation | 6 | 7.7 3.5–17.2ROR 7.8 · χ² 29 / p 4e-8 | 5.3 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Therapy partial responder | 7 | 7.4 3.6–15.6ROR 7.5 · χ² 33 / p 5e-9 | 5.4 EB05 2.7 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Thyroid disorder | 7 | 7.3 3.5–15.2ROR 7.3 · χ² 32 / p 8e-9 | 5.2 EB05 2.7 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Lymphoma | 7 | 7.2 3.5–15.2ROR 7.3 · χ² 32 / p 9e-9 | 5.2 EB05 2.7 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.8 | no trial data cached |
| Malignant neoplasm progression | 43 | 6.8 5.0–9.1ROR 7.0 · χ² 206 / p 4e-47 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 90% clinician | no trial data cached |
| Application site erythema | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Blood creatine phosphokinase increased | 11 | 6.0 3.3–10.9ROR 6.1 · χ² 41 / p 7e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Skin fissures | 7 | 5.9 2.8–12.4ROR 6.0 · χ² 24 / p 5e-7 | 4.4 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Hepatocellular injury | 5 | 5.6 2.3–13.5ROR 5.7 · χ² 15 / p 6e-5 | 3.9 EB05 1.9 · IC025 +0.4 | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Insurance issue | 5 | 5.4 2.2–12.9ROR 5.4 · χ² 14 / p 1e-4 | 3.8 EB05 1.8 · IC025 +0.4 | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Application site pruritus | 7 | 4.9 2.4–10.3ROR 5.0 · χ² 18 / p 1e-5 | 3.9 EB05 2.1 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Eosinophilia | 5 | 4.6 1.9–11.0ROR 4.6 · χ² 11 / p 5e-4 | 3.4 EB05 1.6 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 6 | 3.8 1.7–8.4ROR 3.8 · χ² 10 / p 1e-3 | 3.1 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 5 | 3.4 1.4–8.2ROR 3.4 · χ² 6 / p 0.006 | 2.8 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Skin irritation | 7 | 2.4 1.2–5.1ROR 2.5 · χ² 5 / p 0.016 | 2.2 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious n=1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Hypothyroidism | 75 | 37.8 30.3–47.1ROR 40.1 · χ² 2,649 / p <1e-300 | 37.4 EB05 30.8 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 29.6 · 94% clinician | no trial data cached |
| Disease progression | 57 | 7.7 6.0–10.0ROR 8.1 · χ² 330 / p 5e-74 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 94% clinician | no trial data cached |
| Malignant neoplasm progression | 43 | 6.8 5.0–9.1ROR 7.0 · χ² 206 / p 4e-47 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 90% clinician | no trial data cached |
| Blood cholesterol increased | 26 | 8.9 6.1–13.1ROR 9.1 · χ² 176 / p 2e-40 | 8.1 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.6 | no trial data cached |
| Blood triglycerides increased | 25 | 22.6 15.3–33.4ROR 23.0 · χ² 495 / p 6e-110 | 22.2 EB05 15.8 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 18.5 | no trial data cached |
| Skin lesion | 16 | 9.4 5.8–15.3ROR 9.5 · χ² 112 / p 2e-26 | 8.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Multiple organ dysfunction syndrome | 15 | 8.6 5.2–14.2ROR 8.7 · χ² 94 / p 2e-22 | 7.3 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hepatic cytolysis | 13 | 17.1 9.9–29.3ROR 17.2 · χ² 181 / p 2e-41 | 16.1 EB05 9.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Blood creatine phosphokinase increased | 11 | 6.0 3.3–10.9ROR 6.1 · χ² 41 / p 7e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Application site erythema | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Application site pain | 11 | 8.0 4.4–14.4ROR 8.1 · χ² 61 / p 3e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Hypercholesterolaemia | 11 | 18.4 10.2–33.2ROR 18.6 · χ² 164 / p 7e-38 | 17.3 EB05 9.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Hyperlipidaemia | 10 | 13.4 7.2–24.8ROR 13.5 · χ² 102 / p 2e-24 | 11.5 EB05 5.7 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.2 | no trial data cached |
| Drug eruption | 9 | 8.2 4.3–15.7ROR 8.2 · χ² 50 / p 8e-13 | 6.2 EB05 3.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Adrenal insufficiency | 9 | 12.1 6.3–23.1ROR 12.1 · χ² 80 / p 1e-19 | 9.7 EB05 4.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Bexarotene?
In FDA FAERS, the most frequently co-reported reaction terms for Bexarotene are hypothyroidism, blood cholesterol increased, blood triglycerides increased, skin lesion, multiple organ dysfunction syndrome, hepatic cytolysis. 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 Bexarotene have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: BIRTH DEFECTS Bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. Bexarotene capsules must not be administered to a pregnant woman. ( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning.
Do FAERS signals prove that Bexarotene 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 3292c63c-052f-4f28-b739-530a86e660bf, effective 20240229; matched on
openfda.generic_name.exact:"BEXAROTENE") - 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, 38 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.