Tapinarof side effects: what 1,750 FDA adverse event reports show

Tapinarof · Vtama · 32 reaction terms · 1,522 drug–reaction co-reports · data 2026-09-14

Drug class

Aryl Hydrocarbon Receptor Agonist

FDA label (Established Pharmacologic Class)

Brand names

Vtama

openFDA label

Who reports

1,750 reports · 11% serious · 6 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults.

FDA label, Indications and Usage

What it is

VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder.

FDA label, Description section

Boxed warning

None in the current 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 24 strongest signals

Labeled adverse reaction 5Labeled (related wording) 5Likely indication confounding 3Not in label — unassessed 11

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.
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.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Folliculitis	283	337.4 302.7–376.0ROR 402.2 · χ² 91,997 / p <1e-300	320.9 EB05 290.7 · IC025 +7.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 50.6	no trial data cached
Dermatitis contact	127	135.4 114.4–160.3ROR 146.0 · χ² 16,633 / p <1e-300	131.3 EB05 113.2 · IC025 +6.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=17 · 96% clinician	no trial data cached
Application site pruritus	55	29.1 22.4–37.7ROR 30.0 · χ² 1,462 / p <1e-300	28.8 EB05 22.9 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=2 · 72% consumer	no trial data cached
Application site erythema	61	27.8 21.7–35.6ROR 28.8 · χ² 1,549 / p <1e-300	27.5 EB05 22.2 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=8	no trial data cached
Application site pain	51	27.8 21.2–36.4ROR 28.6 · χ² 1,289 / p 1e-282	27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Pain of skin	43	19.1 14.2–25.7ROR 19.6 · χ² 719 / p 1e-158	18.9 EB05 14.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Application site rash	19	16.5 10.6–25.8ROR 16.7 · χ² 261 / p 4e-59	16.0 EB05 10.4 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Application site irritation	15	14.5 8.7–23.9ROR 14.6 · χ² 174 / p 4e-40	13.5 EB05 8.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Skin burning sensation	81	13.7 11.0–16.9ROR 14.3 · χ² 939 / p 2e-206	13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Dermatitis	19	11.0 7.0–17.2ROR 11.1 · χ² 163 / p 1e-37	10.0 EB05 6.3 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 24.9	no trial data cached
Skin fissures	14	8.9 5.3–15.0ROR 8.9 · χ² 90 / p 1e-21	7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Skin discolouration	27	7.0 4.8–10.2ROR 7.1 · χ² 134 / p 3e-31	6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Psoriasis	75	6.9 5.5–8.6ROR 7.1 · χ² 373 / p 2e-83	6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 23.9	no trial data cached
Rash erythematous	26	6.6 4.5–9.7ROR 6.7 · χ² 119 / p 4e-28	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.3 · 76% consumer	no trial data cached
Pruritus (itching)	207	6.6 5.8–7.5ROR 7.3 · χ² 988 / p 4e-217	6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.4	no trial data cached
Erythema (skin redness)	111	6.5 5.4–7.8ROR 6.8 · χ² 514 / p 5e-114	6.3 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Dermatitis atopic	27	6.5 4.5–9.4ROR 6.6 · χ² 120 / p 3e-28	5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=2	no trial data cached
Skin exfoliation	44	6.3 4.7–8.5ROR 6.5 · χ² 193 / p 3e-44	6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Swelling face	33	6.1 4.3–8.5ROR 6.2 · χ² 135 / p 1e-31	5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · ♀ 80% (drug 53%)	no trial data cached
Skin irritation	23	6.0 4.0–9.0ROR 6.1 · χ² 91 / p 7e-22	5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Acne	35	5.5 4.0–7.6ROR 5.6 · χ² 125 / p 3e-29	5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Eczema	23	5.5 3.6–8.2ROR 5.5 · χ² 80 / p 2e-19	5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.1	no trial data cached
Influenza like illness (flu-like illness)	28	4.1 2.8–5.9ROR 4.1 · χ² 62 / p 2e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.0	no trial data cached
Dry skin	44	4.0 3.0–5.4ROR 4.1 · χ² 97 / p 4e-23	3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	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
Folliculitis	283	337.4 302.7–376.0ROR 402.2 · χ² 91,997 / p <1e-300	320.9 EB05 290.7 · IC025 +7.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 50.6	no trial data cached
Pruritus (itching)	207	6.6 5.8–7.5ROR 7.3 · χ² 988 / p 4e-217	6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.4	no trial data cached
Dermatitis contact	127	135.4 114.4–160.3ROR 146.0 · χ² 16,633 / p <1e-300	131.3 EB05 113.2 · IC025 +6.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=17 · 96% clinician	no trial data cached
Erythema (skin redness)	111	6.5 5.4–7.8ROR 6.8 · χ² 514 / p 5e-114	6.3 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Skin burning sensation	81	13.7 11.0–16.9ROR 14.3 · χ² 939 / p 2e-206	13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Psoriasis	75	6.9 5.5–8.6ROR 7.1 · χ² 373 / p 2e-83	6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 23.9	no trial data cached
Application site erythema	61	27.8 21.7–35.6ROR 28.8 · χ² 1,549 / p <1e-300	27.5 EB05 22.2 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=8	no trial data cached
Application site pruritus	55	29.1 22.4–37.7ROR 30.0 · χ² 1,462 / p <1e-300	28.8 EB05 22.9 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=2 · 72% consumer	no trial data cached
Application site pain	51	27.8 21.2–36.4ROR 28.6 · χ² 1,289 / p 1e-282	27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Dry skin	44	4.0 3.0–5.4ROR 4.1 · χ² 97 / p 4e-23	3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Skin exfoliation	44	6.3 4.7–8.5ROR 6.5 · χ² 193 / p 3e-44	6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Pain of skin	43	19.1 14.2–25.7ROR 19.6 · χ² 719 / p 1e-158	18.9 EB05 14.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Acne	35	5.5 4.0–7.6ROR 5.6 · χ² 125 / p 3e-29	5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Swelling face	33	6.1 4.3–8.5ROR 6.2 · χ² 135 / p 1e-31	5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · ♀ 80% (drug 53%)	no trial data cached
Influenza like illness (flu-like illness)	28	4.1 2.8–5.9ROR 4.1 · χ² 62 / p 2e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.0	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.

Pain of skin — n=43, PRR 19.1
Skin burning sensation — n=81, PRR 13.7
Skin discolouration — n=27, PRR 7.0
Rash erythematous — n=26, PRR 6.6
Erythema — n=111, PRR 6.5
Skin exfoliation — n=44, PRR 6.3
Swelling face — n=33, PRR 6.1
Skin irritation — n=23, PRR 6.0
Acne — n=35, PRR 5.5
Dry skin — n=44, PRR 4.0

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 Tapinarof?

In FDA FAERS, the most frequently co-reported reaction terms for Tapinarof are folliculitis, pruritus, dermatitis contact, erythema, skin burning sensation, 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 Tapinarof have an FDA boxed warning?

No. The FDA label retrieved for Tapinarof has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tapinarof 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 9309d20f-8cd4-4c96-93fa-7f730e83c7ab, effective 20250528; matched on openfda.generic_name.exact:"TAPINAROF")
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, field patient.drug.openfda.generic_name.exact, 32 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.