Pyrithione Zinc side effects: what 580 FDA adverse event reports show

Pyrithione Zinc · 26 reaction terms · 335 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

580 reports · 33% serious · 10 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

fights recurrence of the symptoms of dandruff.

FDA label, Indications and Usage

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 19 strongest signals

Reporting / coding artifact 1No label text to screen 18

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 7 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
Skin fissures	21	40.1 26.4–61.1ROR 41.6 · χ² 762 / p 5e-168	38.8 EB05 26.8 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Dermatitis atopic	35	25.3 18.3–34.8ROR 26.8 · χ² 793 / p 1e-174	24.9 EB05 18.7 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4	no trial data cached
Hair texture abnormal	9	24.0 12.6–46.0ROR 24.4 · χ² 176 / p 1e-40	22.6 EB05 12.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Application site pain	14	22.9 13.7–38.5ROR 23.5 · χ² 272 / p 2e-61	22.2 EB05 13.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=9	no trial data cached
Skin haemorrhage	9	22.5 11.8–43.0ROR 22.8 · χ² 164 / p 8e-38	21.1 EB05 11.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Scratch	6	20.9 9.4–46.3ROR 21.1 · χ² 95 / p 1e-22	17.8 EB05 6.6 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Application site rash	7	18.3 8.8–38.2ROR 18.5 · χ² 98 / p 2e-23	15.8 EB05 6.4 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Skin exfoliation	42	18.2 13.6–24.4ROR 19.6 · χ² 669 / p 1e-147	18.1 EB05 13.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.3	no trial data cached
Eczema	25	17.9 12.2–26.3ROR 18.7 · χ² 383 / p 1e-85	17.6 EB05 12.4 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Pain of skin	12	16.0 9.1–28.0ROR 16.3 · χ² 154 / p 9e-36	14.9 EB05 8.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.4	no trial data cached
Dry skin	58	15.9 12.4–20.3ROR 17.5 · χ² 799 / p 4e-176	15.8 EB05 12.6 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.5	no trial data cached
Application site irritation	5	14.5 6.0–34.7ROR 14.6 · χ² 50 / p 8e-13	10.0 EB05 3.6 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Eye pruritus	11	12.0 6.7–21.6ROR 12.2 · χ² 101 / p 6e-24	10.2 EB05 5.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.0	no trial data cached
Skin irritation	15	11.8 7.1–19.4ROR 12.1 · χ² 138 / p 4e-32	10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3	no trial data cached
Sleep disorder due to a general medical condition	5	11.1 4.7–26.7ROR 11.2 · χ² 37 / p 7e-10	7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Application site erythema	8	11.0 5.5–21.8ROR 11.1 · χ² 63 / p 1e-15	8.3 EB05 4.0 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Psoriatic arthropathy	10	9.0 4.8–16.6ROR 9.1 · χ² 63 / p 1e-15	7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.5	no trial data cached
Therapeutic response shortened	7	7.9 3.8–16.6ROR 8.0 · χ² 36 / p 1e-9	5.7 EB05 2.9 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Skin burning sensation	11	5.6 3.1–10.0ROR 5.7 · χ² 37 / p 6e-10	4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.3	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
Dry skin	58	15.9 12.4–20.3ROR 17.5 · χ² 799 / p 4e-176	15.8 EB05 12.6 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.5	no trial data cached
Skin exfoliation	42	18.2 13.6–24.4ROR 19.6 · χ² 669 / p 1e-147	18.1 EB05 13.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.3	no trial data cached
Dermatitis atopic	35	25.3 18.3–34.8ROR 26.8 · χ² 793 / p 1e-174	24.9 EB05 18.7 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4	no trial data cached
Eczema	25	17.9 12.2–26.3ROR 18.7 · χ² 383 / p 1e-85	17.6 EB05 12.4 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Skin fissures	21	40.1 26.4–61.1ROR 41.6 · χ² 762 / p 5e-168	38.8 EB05 26.8 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Skin irritation	15	11.8 7.1–19.4ROR 12.1 · χ² 138 / p 4e-32	10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3	no trial data cached
Application site pain	14	22.9 13.7–38.5ROR 23.5 · χ² 272 / p 2e-61	22.2 EB05 13.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=9	no trial data cached
Pain of skin	12	16.0 9.1–28.0ROR 16.3 · χ² 154 / p 9e-36	14.9 EB05 8.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.4	no trial data cached
Skin burning sensation	11	5.6 3.1–10.0ROR 5.7 · χ² 37 / p 6e-10	4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.3	no trial data cached
Eye pruritus	11	12.0 6.7–21.6ROR 12.2 · χ² 101 / p 6e-24	10.2 EB05 5.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.0	no trial data cached
Psoriatic arthropathy	10	9.0 4.8–16.6ROR 9.1 · χ² 63 / p 1e-15	7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.5	no trial data cached
Skin haemorrhage	9	22.5 11.8–43.0ROR 22.8 · χ² 164 / p 8e-38	21.1 EB05 11.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Hair texture abnormal	9	24.0 12.6–46.0ROR 24.4 · χ² 176 / p 1e-40	22.6 EB05 12.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Application site erythema	8	11.0 5.5–21.8ROR 11.1 · χ² 63 / p 1e-15	8.3 EB05 4.0 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Therapeutic response shortened	7	7.9 3.8–16.6ROR 8.0 · χ² 36 / p 1e-9	5.7 EB05 2.9 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	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 Pyrithione Zinc?

In FDA FAERS, the most frequently co-reported reaction terms for Pyrithione Zinc are dry skin, skin exfoliation, dermatitis atopic, eczema, skin fissures, skin irritation. 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 Pyrithione Zinc have an FDA boxed warning?

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

Do FAERS signals prove that Pyrithione Zinc 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 003c585f-9fda-c86e-e063-6394a90ae377, effective 20251231; matched on openfda.generic_name.exact:"PYRITHIONE ZINC")
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, 26 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.