Tazarotene side effects: what 1,167 FDA adverse event reports show
Brand names
Trilitas
Who reports
1,167 reports · 35% serious · 15 with death outcome · 69% female
Used for
Trilitas™ gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Trilitas™ gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of Trilitas™ gel use on more than 20% body surface area has not been established.
What it is
Trilitas™ (tazarotene) gel, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of Trilitas™ gel, 0.1% contains 1 mg of tazarotene in a clear to yellow translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids.
Boxed warning
None in the current label
Causality screen of the 20 strongest signals
What the badges mean
- 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. 17 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 |
|---|---|---|---|---|---|---|
| Application site pain | 38 | 31.1 22.7–42.5ROR 32.1 · χ² 1,075 / p 4e-236 | 30.6 EB05 23.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=2 · 71% consumer | no trial data cached |
| Application site erythema | 45 | 30.8 23.1–41.0ROR 32.0 · χ² 1,266 / p 1e-277 | 30.4 EB05 23.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 73% consumer | no trial data cached |
| Pregnancy | 32 | 28.5 20.2–40.1ROR 29.2 · χ² 820 / p 1e-180 | 28.0 EB05 20.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.3 · ♀ 94% (drug 69%) | no trial data cached |
| Inflammatory bowel disease | 14 | 25.6 15.2–43.1ROR 25.9 · χ² 307 / p 6e-69 | 24.8 EB05 15.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 43.2 | no trial data cached |
| Application site irritation | 14 | 20.2 12.0–34.1ROR 20.5 · χ² 237 / p 9e-54 | 19.5 EB05 12.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Skin exfoliation | 76 | 16.4 13.2–20.4ROR 17.5 · χ² 1,091 / p 2e-239 | 16.4 EB05 13.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 75% consumer | no trial data cached |
| Drug exposure during pregnancy | 25 | 13.0 8.8–19.2ROR 13.3 · χ² 266 / p 4e-60 | 12.5 EB05 8.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 22.0 | no trial data cached |
| Skin irritation | 30 | 11.8 8.3–16.7ROR 12.0 · χ² 285 / p 3e-64 | 11.2 EB05 8.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=3 · 79% consumer | no trial data cached |
| Blood triglycerides increased | 11 | 11.2 6.2–20.1ROR 11.3 · χ² 92 / p 5e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 26.3 | no trial data cached |
| Scar | 10 | 10.5 5.7–19.4ROR 10.6 · χ² 77 / p 1e-18 | 8.4 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Acne | 42 | 9.9 7.4–13.3ROR 10.2 · χ² 329 / p 9e-74 | 9.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 21.1 | no trial data cached |
| Application site pruritus | 11 | 8.7 4.8–15.7ROR 8.8 · χ² 68 / p 1e-16 | 6.9 EB05 4.0 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Burning sensation | 31 | 7.9 5.6–11.2ROR 8.1 · χ² 182 / p 9e-42 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.9 · 71% consumer | no trial data cached |
| Erythema (skin redness) | 82 | 7.2 5.8–8.8ROR 7.6 · χ² 434 / p 1e-96 | 6.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 72% consumer | no trial data cached |
| Psoriatic arthropathy | 15 | 6.7 4.1–11.1ROR 6.8 · χ² 67 / p 1e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.0 | no trial data cached |
| Skin burning sensation | 25 | 6.3 4.3–9.3ROR 6.4 · χ² 107 / p 2e-25 | 5.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 75% consumer | no trial data cached |
| Dry skin | 42 | 5.7 4.3–7.7ROR 5.9 · χ² 161 / p 4e-37 | 5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Psoriasis | 40 | 5.5 4.1–7.5ROR 5.7 · χ² 144 / p 2e-33 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.8 | no trial data cached |
| Abortion spontaneous | 12 | 5.4 3.1–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 | no trial data cached |
| Colitis ulcerative | 11 | 4.4 2.5–8.0ROR 4.5 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | 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 |
|---|---|---|---|---|---|---|
| Erythema (skin redness) | 82 | 7.2 5.8–8.8ROR 7.6 · χ² 434 / p 1e-96 | 6.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 72% consumer | no trial data cached |
| Skin exfoliation | 76 | 16.4 13.2–20.4ROR 17.5 · χ² 1,091 / p 2e-239 | 16.4 EB05 13.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 75% consumer | no trial data cached |
| Application site erythema | 45 | 30.8 23.1–41.0ROR 32.0 · χ² 1,266 / p 1e-277 | 30.4 EB05 23.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 73% consumer | no trial data cached |
| Dry skin | 42 | 5.7 4.3–7.7ROR 5.9 · χ² 161 / p 4e-37 | 5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Acne | 42 | 9.9 7.4–13.3ROR 10.2 · χ² 329 / p 9e-74 | 9.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 21.1 | no trial data cached |
| Psoriasis | 40 | 5.5 4.1–7.5ROR 5.7 · χ² 144 / p 2e-33 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.8 | no trial data cached |
| Application site pain | 38 | 31.1 22.7–42.5ROR 32.1 · χ² 1,075 / p 4e-236 | 30.6 EB05 23.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=2 · 71% consumer | no trial data cached |
| Pregnancy | 32 | 28.5 20.2–40.1ROR 29.2 · χ² 820 / p 1e-180 | 28.0 EB05 20.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.3 · ♀ 94% (drug 69%) | no trial data cached |
| Burning sensation | 31 | 7.9 5.6–11.2ROR 8.1 · χ² 182 / p 9e-42 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.9 · 71% consumer | no trial data cached |
| Skin irritation | 30 | 11.8 8.3–16.7ROR 12.0 · χ² 285 / p 3e-64 | 11.2 EB05 8.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=3 · 79% consumer | no trial data cached |
| Skin burning sensation | 25 | 6.3 4.3–9.3ROR 6.4 · χ² 107 / p 2e-25 | 5.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 75% consumer | no trial data cached |
| Drug exposure during pregnancy | 25 | 13.0 8.8–19.2ROR 13.3 · χ² 266 / p 4e-60 | 12.5 EB05 8.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 22.0 | no trial data cached |
| Psoriatic arthropathy | 15 | 6.7 4.1–11.1ROR 6.8 · χ² 67 / p 1e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.0 | no trial data cached |
| Application site irritation | 14 | 20.2 12.0–34.1ROR 20.5 · χ² 237 / p 9e-54 | 19.5 EB05 12.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Inflammatory bowel disease | 14 | 25.6 15.2–43.1ROR 25.9 · χ² 307 / p 6e-69 | 24.8 EB05 15.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 43.2 | 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.
- Burning sensation — n=31, PRR 7.9
- Skin burning sensation — n=25, PRR 6.3
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 Tazarotene?
In FDA FAERS, the most frequently co-reported reaction terms for Tazarotene are erythema, skin exfoliation, application site erythema, dry skin, acne, psoriasis. 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 Tazarotene have an FDA boxed warning?
No. The FDA label retrieved for Tazarotene has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tazarotene 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 1cf1faef-73b8-4ab2-a4c8-521f0bd3fc10, effective 20260518; matched on
openfda.generic_name.exact:"TAZAROTENE") - 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, 37 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.