Drug · FAERS side-effect profile with label screen
Skin Protectant side effects: what 3,085 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Zinc Oxide
openFDA label
Who reports
3,085 reports · 88% serious · 436 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• Dries the oozing and weeping of poison: • Ivy • Oak • Sumac
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 40 strongest signals
Reporting / coding artifact 1Lab value / disease marker 2No label text to screen 37
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.
- 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.
- 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. 182 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 460 | 273.0 250.4–297.6ROR 320.6 · χ² 119,586 / p <1e-300 | 259.5 EB05 240.2 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.4 · ♀ 100% (drug 57%) | no trial data cached |
| Vaginal discharge | 148 | 101.6 86.7–119.1ROR 106.7 · χ² 14,435 / p <1e-300 | 98.9 EB05 86.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=148 · ♀ 100% (drug 57%) | no trial data cached |
| Paraesthesia oral | 198 | 94.9 82.9–108.8ROR 101.4 · χ² 18,068 / p <1e-300 | 92.8 EB05 82.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 109.0 · ♀ 100% (drug 57%) | no trial data cached |
| Oral candidiasis (oral thrush) | 149 | 78.7 67.3–92.2ROR 82.7 · χ² 11,233 / p <1e-300 | 77.1 EB05 67.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.9 · ♀ 100% (drug 57%) | no trial data cached |
| Procedural pain | 190 | 47.0 40.9–54.0ROR 50.0 · χ² 8,462 / p <1e-300 | 46.5 EB05 41.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.7 · ♀ 100% (drug 57%) | no trial data cached |
| Frequent bowel movements | 152 | 38.6 33.1–45.1ROR 40.6 · χ² 5,507 / p <1e-300 | 38.2 EB05 33.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.3 · ♀ 98% (drug 57%) | no trial data cached |
| Colitis | 160 | 29.0 24.9–33.7ROR 30.5 · χ² 4,285 / p <1e-300 | 28.8 EB05 25.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 96% (drug 57%) | no trial data cached |
| Rectal haemorrhage | 162 | 25.6 22.1–29.8ROR 27.0 · χ² 3,803 / p <1e-300 | 25.5 EB05 22.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 96% (drug 57%) | no trial data cached |
| Colitis ulcerative | 153 | 23.4 20.0–27.3ROR 24.6 · χ² 3,253 / p <1e-300 | 23.3 EB05 20.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · ♀ 98% (drug 57%) | no trial data cached |
| Therapeutic product effect incomplete | 222 | 21.4 18.9–24.3ROR 23.0 · χ² 4,298 / p <1e-300 | 21.3 EB05 19.1 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 · ♀ 98% (drug 57%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 206 | 21.3 18.6–24.3ROR 22.7 · χ² 3,957 / p <1e-300 | 21.2 EB05 18.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.3 · ♀ 96% (drug 57%) | no trial data cached |
| Haematochezia (blood in stool) | 171 | 21.2 18.3–24.5ROR 22.3 · χ² 3,262 / p <1e-300 | 21.0 EB05 18.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.1 · ♀ 93% (drug 57%) | no trial data cached |
| Accident | 36 | 20.6 14.9–28.5ROR 20.8 · χ² 651 / p 8e-144 | 20.3 EB05 15.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 · ♀ 0% (drug 57%) · 97% clinician | no trial data cached |
| Nephropathy | 26 | 18.9 12.9–27.7ROR 19.0 · χ² 422 / p 6e-94 | 18.5 EB05 13.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · ♀ 100% (drug 57%) | no trial data cached |
| Body height decreased | 25 | 15.8 10.7–23.3ROR 15.9 · χ² 330 / p 4e-74 | 15.4 EB05 10.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 96% (drug 57%) | no trial data cached |
| Haemorrhoids | 43 | 15.0 11.1–20.2ROR 15.2 · χ² 547 / p 3e-121 | 14.8 EB05 11.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 7% (drug 57%) | no trial data cached |
| Dyspepsia (indigestion) | 210 | 14.6 12.8–16.6ROR 15.6 · χ² 2,649 / p <1e-300 | 14.5 EB05 12.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 96% (drug 57%) | no trial data cached |
| Body temperature increased | 42 | 14.0 10.3–18.9ROR 14.1 · χ² 492 / p 2e-109 | 13.7 EB05 10.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 11.3 · ♀ 10% (drug 57%) · 95% clinician | no trial data cached |
| Schizophrenia | 23 | 12.9 8.6–19.4ROR 13.0 · χ² 240 / p 2e-54 | 12.2 EB05 8.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · ♀ 100% (drug 57%) · 91% clinician | no trial data cached |
| Bacteraemia | 21 | 12.1 7.9–18.6ROR 12.2 · χ² 204 / p 2e-46 | 11.3 EB05 7.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Sciatica | 28 | 12.0 8.3–17.4ROR 12.1 · χ² 272 / p 2e-61 | 11.4 EB05 8.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 57%) | no trial data cached |
| Obesity | 28 | 11.9 8.3–17.3ROR 12.0 · χ² 270 / p 7e-61 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 100% (drug 57%) | no trial data cached |
| Joint range of motion decreased | 23 | 11.7 7.8–17.6ROR 11.8 · χ² 215 / p 7e-49 | 10.9 EB05 7.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 · ♀ 100% (drug 57%) | no trial data cached |
| Malnutrition | 19 | 11.6 7.4–18.2ROR 11.7 · χ² 174 / p 5e-40 | 10.7 EB05 6.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Febrile neutropenia | 113 | 11.6 9.7–13.9ROR 12.0 · χ² 1,087 / p 9e-239 | 11.5 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 35% (drug 57%) · 95% clinician | no trial data cached |
| Pneumonia aspiration | 42 | 11.5 8.5–15.5ROR 11.6 · χ² 391 / p 3e-87 | 11.1 EB05 8.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 21% (drug 57%) · 95% clinician | no trial data cached |
| Disseminated intravascular coagulation | 23 | 11.1 7.4–16.7ROR 11.2 · χ² 201 / p 7e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 96% clinician | no trial data cached |
| Cholelithiasis | 51 | 10.6 8.1–13.9ROR 10.7 · χ² 433 / p 2e-96 | 10.2 EB05 7.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 94% (drug 57%) | no trial data cached |
| Hepatic steatosis | 28 | 10.2 7.1–14.8ROR 10.3 · χ² 224 / p 5e-51 | 9.5 EB05 6.7 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 89% (drug 57%) | no trial data cached |
| Synovitis | 25 | 9.4 6.4–13.9ROR 9.5 · χ² 180 / p 3e-41 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · ♀ 100% (drug 57%) | no trial data cached |
| Blood bilirubin increased | 37 | 9.3 6.7–12.8ROR 9.4 · χ² 266 / p 5e-60 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 · ♀ 85% (drug 57%) · 97% clinician | no trial data cached |
| Drug eruption | 24 | 9.3 6.2–13.8ROR 9.3 · χ² 169 / p 7e-39 | 8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Foot deformity | 15 | 9.2 5.5–15.2ROR 9.2 · χ² 101 / p 4e-24 | 7.8 EB05 4.8 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Hepatotoxicity (liver damage) | 29 | 8.9 6.2–12.8ROR 9.0 · χ² 196 / p 1e-44 | 8.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 89% (drug 57%) · 100% clinician | no trial data cached |
| Ileus | 16 | 8.8 5.4–14.4ROR 8.9 · χ² 104 / p 1e-24 | 7.6 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Limb injury | 34 | 8.5 6.1–11.9ROR 8.6 · χ² 219 / p 8e-50 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · ♀ 84% (drug 57%) | no trial data cached |
| Anaemia (low red blood cells) | 237 | 8.5 7.5–9.6ROR 9.1 · χ² 1,562 / p <1e-300 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 82% (drug 57%) | no trial data cached |
| Knee arthroplasty | 24 | 7.8 5.3–11.7ROR 7.9 · χ² 136 / p 9e-32 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · ♀ 87% (drug 57%) | no trial data cached |
| Pyrexia (fever) | 397 | 7.8 7.1–8.6ROR 8.8 · χ² 2,384 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Constipation | 238 | 7.5 6.6–8.5ROR 8.0 · χ² 1,343 / p 3e-294 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 82% (drug 57%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 559 | 2.9 2.7–3.1ROR 3.3 · χ² 733 / p 9e-162 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · ♀ 92% (drug 57%) | no trial data cached |
| Macular degeneration | 460 | 273.0 250.4–297.6ROR 320.6 · χ² 119,586 / p <1e-300 | 259.5 EB05 240.2 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.4 · ♀ 100% (drug 57%) | no trial data cached |
| Pyrexia (fever) | 397 | 7.8 7.1–8.6ROR 8.8 · χ² 2,384 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Pain | 315 | 3.5 3.1–3.9ROR 3.8 · χ² 571 / p 2e-126 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · ♀ 79% (drug 57%) | no trial data cached |
| Malaise (feeling unwell) | 311 | 4.8 4.3–5.3ROR 5.2 · χ² 955 / p 6e-210 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · ♀ 79% (drug 57%) | no trial data cached |
| Weight decreased (weight loss) | 266 | 6.5 5.8–7.3ROR 7.0 · χ² 1,244 / p 9e-273 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · ♀ 87% (drug 57%) | no trial data cached |
| Abdominal pain | 243 | 7.1 6.3–8.0ROR 7.6 · χ² 1,283 / p 3e-281 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 86% (drug 57%) | no trial data cached |
| Constipation | 238 | 7.5 6.6–8.5ROR 8.0 · χ² 1,343 / p 3e-294 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 82% (drug 57%) | no trial data cached |
| Anaemia (low red blood cells) | 237 | 8.5 7.5–9.6ROR 9.1 · χ² 1,562 / p <1e-300 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 82% (drug 57%) | no trial data cached |
| Therapeutic product effect incomplete | 222 | 21.4 18.9–24.3ROR 23.0 · χ² 4,298 / p <1e-300 | 21.3 EB05 19.1 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 · ♀ 98% (drug 57%) | no trial data cached |
| Dyspepsia (indigestion) | 210 | 14.6 12.8–16.6ROR 15.6 · χ² 2,649 / p <1e-300 | 14.5 EB05 12.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 96% (drug 57%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 206 | 21.3 18.6–24.3ROR 22.7 · χ² 3,957 / p <1e-300 | 21.2 EB05 18.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.3 · ♀ 96% (drug 57%) | no trial data cached |
| Paraesthesia oral | 198 | 94.9 82.9–108.8ROR 101.4 · χ² 18,068 / p <1e-300 | 92.8 EB05 82.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 109.0 · ♀ 100% (drug 57%) | no trial data cached |
| Erythema (skin redness) | 190 | 6.3 5.5–7.2ROR 6.6 · χ² 849 / p 7e-187 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 90% (drug 57%) | no trial data cached |
| Procedural pain | 190 | 47.0 40.9–54.0ROR 50.0 · χ² 8,462 / p <1e-300 | 46.5 EB05 41.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.7 · ♀ 100% (drug 57%) | 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 Skin Protectant?
In FDA FAERS, the most frequently co-reported reaction terms for Skin Protectant are macular degeneration, pyrexia, pain, malaise, weight decreased, abdominal pain. 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 Skin Protectant have an FDA boxed warning?
No. The FDA label retrieved for Skin Protectant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Skin Protectant 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 d9b752e6-655a-19a6-e053-2995a90a9a37, effective 20231117; matched on
openfda.generic_name.exact:"SKIN PROTECTANT") - 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, 222 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.