Drug · FAERS side-effect profile with label screen
Tretinoin side effects: what 8,063 FDA adverse event reports show
Who reports
8,063 reports · 60% serious · 864 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
FDA label, Indications and Usage
Boxed warning
EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules.
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 2Labeled (related wording) 5Likely indication confounding 3Lab value / disease marker 3Not in label — unassessed 27
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 (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.
- 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. 1,001 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 |
|---|---|---|---|---|---|---|
| Retinoic acid syndrome | 72 | 1,845.5 1,364.2–2,496.5ROR 1,862.1 · χ² 76,100 / p <1e-300 | 833.6 EB05 684.2 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=72 · ♀ 38% (drug 77%) · 100% clinician | no trial data cached |
| Acute promyelocytic leukaemia differentiation syndrome | 78 | 1,537.9 1,162.5–2,034.6ROR 1,552.9 · χ² 73,918 / p <1e-300 | 776.9 EB05 642.6 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=76 · ♀ 55% (drug 77%) · 96% clinician | no trial data cached |
| Differentiation syndrome | 228 | 1,222.6 1,045.8–1,429.3ROR 1,258.1 · χ² 187,600 / p <1e-300 | 773.9 EB05 693.2 · IC025 +8.0 3/3 methods agree | Labeled — boxed warning exact term | serious n=228 · ♀ 48% (drug 77%) · 100% clinician | no trial data cached |
| Overlap syndrome | 88 | 380.4 304.4–475.3ROR 384.5 · χ² 28,665 / p <1e-300 | 309.1 EB05 258.6 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 77%) · 92% clinician | no trial data cached |
| Haematopoietic neoplasm | 20 | 308.8 194.3–490.9ROR 309.6 · χ² 5,205 / p <1e-300 | 218.4 EB05 149.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Hypocholesterolaemia | 27 | 249.8 168.4–370.7ROR 250.7 · χ² 5,873 / p <1e-300 | 196.3 EB05 141.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 77%) · 93% clinician | no trial data cached |
| Bone marrow necrosis | 18 | 214.6 132.7–346.9ROR 215.1 · χ² 3,337 / p <1e-300 | 164.0 EB05 109.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Myelodysplastic syndrome transformation | 29 | 151.7 104.4–220.5ROR 152.2 · χ² 3,958 / p <1e-300 | 131.1 EB05 95.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Blepharospasm | 298 | 131.1 116.9–147.0ROR 136.1 · χ² 36,484 / p <1e-300 | 123.8 EB05 112.4 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=296 · ♀ 100% (drug 77%) | no trial data cached |
| Subcutaneous drug absorption impaired | 24 | 119.7 79.5–180.1ROR 120.0 · χ² 2,586 / p <1e-300 | 105.0 EB05 74.3 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Facet joint syndrome | 136 | 117.1 98.8–138.9ROR 119.1 · χ² 14,866 / p <1e-300 | 110.4 EB05 95.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=136 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Lupus vulgaris | 49 | 111.5 83.9–148.4ROR 112.2 · χ² 5,039 / p <1e-300 | 102.7 EB05 80.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 77%) · 94% clinician | no trial data cached |
| Peripheral venous disease | 157 | 106.3 90.8–124.5ROR 108.4 · χ² 15,629 / p <1e-300 | 100.9 EB05 88.3 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=156 · ♀ 100% (drug 77%) · 96% clinician | no trial data cached |
| Central hypothyroidism | 12 | 105.0 59.0–186.9ROR 105.1 · χ² 1,089 / p 3e-239 | 87.3 EB05 53.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Acute promyelocytic leukaemia | 38 | 100.4 72.7–138.7ROR 100.9 · χ² 3,504 / p <1e-300 | 92.3 EB05 70.2 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=37 · ♀ 34% (drug 77%) · 94% clinician | no trial data cached |
| Infusion site reaction | 107 | 99.3 82.0–120.3ROR 100.6 · χ² 9,930 / p <1e-300 | 94.1 EB05 80.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Rheumatic fever | 157 | 96.9 82.7–113.4ROR 98.8 · χ² 14,262 / p <1e-300 | 92.3 EB05 80.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=157 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Onychomadesis | 149 | 96.6 82.2–113.6ROR 98.4 · χ² 13,501 / p <1e-300 | 92.1 EB05 80.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=147 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Dislocation of vertebra | 61 | 73.2 56.8–94.4ROR 73.8 · χ² 4,156 / p <1e-300 | 69.7 EB05 56.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Benign intracranial hypertension | 34 | 71.3 50.8–100.2ROR 71.6 · χ² 2,226 / p <1e-300 | 66.9 EB05 50.1 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious n=34 · 100% clinician | no trial data cached |
| Hyperleukocytosis | 23 | 70.2 46.4–106.1ROR 70.4 · χ² 1,460 / p <1e-300 | 64.8 EB05 45.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Breast cancer stage iii | 161 | 66.7 57.1–77.8ROR 68.0 · χ² 10,089 / p <1e-300 | 64.5 EB05 56.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=161 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| C-reactive protein | 22 | 64.5 42.3–98.4ROR 64.7 · χ² 1,281 / p 9e-281 | 59.9 EB05 41.7 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=22 · ♀ 100% (drug 77%) · 91% clinician | no trial data cached |
| Leukaemia recurrent | 40 | 62.9 46.0–86.1ROR 63.2 · χ² 2,320 / p <1e-300 | 59.8 EB05 45.8 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=40 · ♀ 38% (drug 77%) · 100% clinician | no trial data cached |
| Deep vein thrombosis postoperative | 43 | 58.2 43.1–78.7ROR 58.5 · χ² 2,309 / p <1e-300 | 55.6 EB05 43.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Anti-cyclic citrullinated peptide antibody positive | 155 | 57.9 49.5–67.8ROR 59.0 · χ² 8,425 / p <1e-300 | 56.3 EB05 49.2 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 54.8 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Retinitis | 34 | 54.0 38.5–75.8ROR 54.2 · χ² 1,681 / p <1e-300 | 51.5 EB05 38.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Duodenal ulcer perforation | 146 | 52.7 44.8–62.0ROR 53.7 · χ² 7,209 / p <1e-300 | 51.3 EB05 44.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 49.8 · ♀ 100% (drug 77%) · 97% clinician | no trial data cached |
| Idiopathic intracranial hypertension | 40 | 47.1 34.5–64.3ROR 47.3 · χ² 1,726 / p <1e-300 | 45.3 EB05 34.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=40 · 95% clinician | no trial data cached |
| Live birth | 147 | 46.7 39.7–54.9ROR 47.5 · χ² 6,412 / p <1e-300 | 45.6 EB05 39.8 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 53.9 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Lip dry | 153 | 45.1 38.5–52.9ROR 46.0 · χ² 6,446 / p <1e-300 | 44.1 EB05 38.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=148 · 96% clinician | no trial data cached |
| Application site exfoliation | 70 | 44.6 35.3–56.5ROR 45.0 · χ² 2,893 / p <1e-300 | 43.4 EB05 35.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Muscle injury | 136 | 43.8 37.0–51.8ROR 44.5 · χ² 5,548 / p <1e-300 | 42.8 EB05 37.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 45.0 · ♀ 100% (drug 77%) · 98% clinician | no trial data cached |
| X-ray abnormal | 29 | 42.9 29.7–61.9ROR 43.0 · χ² 1,126 / p 3e-247 | 41.1 EB05 30.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=29 · ♀ 100% (drug 77%) · 100% clinician | no trial data cached |
| Folliculitis | 166 | 42.4 36.4–49.4ROR 43.3 · χ² 6,568 / p <1e-300 | 41.6 EB05 36.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.3 · ♀ 99% (drug 77%) · 96% clinician | no trial data cached |
| Taste disorder | 322 | 42.4 38.1–47.3ROR 44.1 · χ² 12,783 / p <1e-300 | 41.7 EB05 38.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 80.4 · ♀ 100% (drug 77%) · 90% clinician | no trial data cached |
| Cytogenetic abnormality | 17 | 39.5 24.5–63.7ROR 39.6 · χ² 591 / p 8e-131 | 37.4 EB05 24.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Adjustment disorder with depressed mood | 30 | 39.2 27.4–56.2ROR 39.4 · χ² 1,064 / p 1e-233 | 37.8 EB05 27.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 77%) · 93% clinician | no trial data cached |
| Back injury | 159 | 38.7 33.2–45.2ROR 39.5 · χ² 5,721 / p <1e-300 | 38.0 EB05 33.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.1 · ♀ 98% (drug 77%) · 95% clinician | no trial data cached |
| Nail disorder | 124 | 37.6 31.5–44.8ROR 38.2 · χ² 4,320 / p <1e-300 | 36.9 EB05 31.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 100% (drug 77%) · 96% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 953 | 2.9 2.7–3.0ROR 3.1 · χ² 1,195 / p 3e-262 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Drug ineffective (drug did not work) | 841 | 1.7 1.6–1.8ROR 1.7 · χ² 235 / p 3e-53 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Pain | 585 | 2.5 2.3–2.7ROR 2.6 · χ² 526 / p 9e-117 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Product use in unapproved indication | 500 | 5.3 4.9–5.8ROR 5.6 · χ² 1,770 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Vomiting | 496 | 2.8 2.5–3.0ROR 2.9 · χ² 563 / p 9e-125 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Nausea | 441 | 1.5 1.3–1.6ROR 1.5 · χ² 64 / p 6e-16 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Rash | 433 | 2.6 2.4–2.8ROR 2.7 · χ² 432 / p 3e-96 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Headache | 420 | 1.7 1.6–1.9ROR 1.8 · χ² 136 / p 8e-32 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Diarrhoea (diarrhea) | 408 | 1.6 1.5–1.8ROR 1.7 · χ² 107 / p 3e-25 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Paraesthesia (tingling/numbness) | 394 | 6.5 5.9–7.2ROR 6.8 · χ² 1,839 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Abdominal pain upper | 373 | 4.7 4.3–5.2ROR 4.9 · χ² 1,100 / p 1e-241 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · ♀ 97% (drug 77%) | no trial data cached |
| Fatigue (tiredness) | 362 | 1.2 1.1–1.3ROR 1.2 · χ² 14 / p 1e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Hypoaesthesia (numbness) | 352 | 6.1 5.5–6.8ROR 6.3 · χ² 1,508 / p <1e-300 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 97% (drug 77%) | no trial data cached |
| Depression | 346 | 3.9 3.6–4.4ROR 4.1 · χ² 763 / p 3e-168 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Drug intolerance | 338 | 9.2 8.2–10.2ROR 9.5 · χ² 2,449 / p <1e-300 | 9.1 EB05 8.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · ♀ 98% (drug 77%) | 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.
- Overlap syndrome — n=88, PRR 380.4
- Haematopoietic neoplasm — n=20, PRR 308.8
- Hypocholesterolaemia — n=27, PRR 249.8
- Myelodysplastic syndrome transformation — n=29, PRR 151.7
- Blepharospasm — n=298, PRR 131.1
- Facet joint syndrome — n=136, PRR 117.1
- Lupus vulgaris — n=49, PRR 111.5
- Infusion site reaction — n=107, PRR 99.3
- Rheumatic fever — n=157, PRR 96.9
- Onychomadesis — n=149, PRR 96.6
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 Tretinoin?
In FDA FAERS, the most frequently co-reported reaction terms for Tretinoin are pain, vomiting, nausea, rash, headache, diarrhoea. 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 Tretinoin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules.
Do FAERS signals prove that Tretinoin 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 045258e2-5efb-4147-bf74-4c43af04dccc, effective 20260526; matched on
openfda.generic_name.exact:"TRETINOIN") - 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, 1,041 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.