Drug · FAERS side-effect profile with label screen
Zinc Oxide Ointment side effects: what 1,971 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Zinc Oxide
openFDA label
Who reports
1,971 reports · 85% serious · 211 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
dries the oozing and weeping of: ■ poison ivy ■ poison oak ■ poison 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. 68 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 | 427.3 393.6–463.9ROR 557.1 · χ² 187,683 / p <1e-300 | 403.7 EB05 373.7 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 299.6 · ♀ 100% (drug 63%) | no trial data cached |
| Vaginal discharge | 147 | 158.0 135.1–184.8ROR 170.6 · χ² 22,449 / p <1e-300 | 152.6 EB05 133.0 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=147 · ♀ 100% (drug 63%) | no trial data cached |
| Paraesthesia oral | 198 | 148.6 130.1–169.8ROR 165.1 · χ² 28,500 / p <1e-300 | 144.5 EB05 128.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 176.1 · ♀ 100% (drug 63%) | no trial data cached |
| Oral candidiasis (oral thrush) | 148 | 122.4 104.7–143.1ROR 132.3 · χ² 17,508 / p <1e-300 | 119.2 EB05 103.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.9 · ♀ 100% (drug 63%) | no trial data cached |
| Procedural pain | 190 | 73.6 64.3–84.3ROR 81.3 · χ² 13,455 / p <1e-300 | 72.6 EB05 64.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.1 · ♀ 100% (drug 63%) | no trial data cached |
| Frequent bowel movements | 152 | 60.4 51.9–70.4ROR 65.4 · χ² 8,787 / p <1e-300 | 59.7 EB05 52.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.9 · ♀ 98% (drug 63%) | no trial data cached |
| Colitis | 150 | 42.5 36.5–49.6ROR 46.0 · χ² 6,028 / p <1e-300 | 42.2 EB05 36.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 · ♀ 98% (drug 63%) | no trial data cached |
| Rectal haemorrhage | 163 | 40.4 34.8–46.8ROR 43.9 · χ² 6,208 / p <1e-300 | 40.0 EB05 35.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 95% (drug 63%) | no trial data cached |
| Colitis ulcerative | 151 | 36.1 31.0–42.1ROR 39.1 · χ² 5,117 / p <1e-300 | 35.9 EB05 31.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 · ♀ 99% (drug 63%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 201 | 32.5 28.5–37.0ROR 36.0 · χ² 6,099 / p <1e-300 | 32.3 EB05 28.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · ♀ 98% (drug 63%) | no trial data cached |
| Therapeutic product effect incomplete | 214 | 32.3 28.4–36.7ROR 36.1 · χ² 6,460 / p <1e-300 | 32.1 EB05 28.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 40.8 · ♀ 99% (drug 63%) | no trial data cached |
| Accident | 36 | 32.3 23.3–44.6ROR 32.8 · χ² 1,057 / p 4e-232 | 31.7 EB05 23.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 · ♀ 0% (drug 63%) · 97% clinician | no trial data cached |
| Haematochezia (blood in stool) | 158 | 30.6 26.3–35.5ROR 33.2 · χ² 4,491 / p <1e-300 | 30.4 EB05 26.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.6 · ♀ 99% (drug 63%) | no trial data cached |
| Nephropathy | 24 | 27.3 18.3–40.6ROR 27.6 · χ² 580 / p 2e-128 | 26.7 EB05 18.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · ♀ 100% (drug 63%) | no trial data cached |
| Body height decreased | 24 | 23.7 15.9–35.2ROR 23.9 · χ² 498 / p 2e-110 | 23.2 EB05 16.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 96% (drug 63%) | no trial data cached |
| Haemorrhoids | 42 | 22.9 17.0–30.9ROR 23.4 · χ² 857 / p 1e-188 | 22.7 EB05 17.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.3 · ♀ 7% (drug 63%) · 90% clinician | no trial data cached |
| Dyspepsia (indigestion) | 199 | 21.6 19.0–24.7ROR 23.9 · χ² 3,904 / p <1e-300 | 21.5 EB05 19.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.7 · ♀ 97% (drug 63%) | no trial data cached |
| Body temperature increased | 39 | 20.3 14.9–27.7ROR 20.7 · χ² 696 / p 1e-153 | 20.1 EB05 15.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 16.9 · ♀ 5% (drug 63%) · 97% clinician | no trial data cached |
| Schizophrenia | 22 | 19.3 12.7–29.2ROR 19.5 · χ² 363 / p 4e-81 | 18.9 EB05 13.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.5 · ♀ 100% (drug 63%) · 100% clinician | no trial data cached |
| Obesity | 28 | 18.7 12.9–27.0ROR 19.0 · χ² 451 / p 2e-100 | 18.4 EB05 13.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 · ♀ 100% (drug 63%) | no trial data cached |
| Joint range of motion decreased | 23 | 18.3 12.2–27.5ROR 18.5 · χ² 359 / p 2e-80 | 18.0 EB05 12.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.8 · ♀ 100% (drug 63%) | no trial data cached |
| Sciatica | 27 | 18.1 12.5–26.4ROR 18.4 · χ² 420 / p 1e-93 | 17.8 EB05 12.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 · ♀ 100% (drug 63%) | no trial data cached |
| Cholelithiasis | 47 | 15.3 11.5–20.3ROR 15.6 · χ² 612 / p 2e-135 | 15.1 EB05 11.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 96% (drug 63%) | no trial data cached |
| Hepatic steatosis | 26 | 14.9 10.2–21.8ROR 15.1 · χ² 323 / p 2e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 92% (drug 63%) | no trial data cached |
| Foot deformity | 15 | 14.4 8.7–23.8ROR 14.5 · χ² 174 / p 6e-40 | 13.4 EB05 7.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.3 | no trial data cached |
| Synovitis | 24 | 14.2 9.5–21.1ROR 14.3 · χ² 280 / p 3e-63 | 13.7 EB05 9.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · ♀ 100% (drug 63%) | no trial data cached |
| Hepatotoxicity (liver damage) | 27 | 13.0 8.9–18.9ROR 13.1 · χ² 286 / p 1e-64 | 12.5 EB05 8.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · ♀ 88% (drug 63%) · 100% clinician | no trial data cached |
| Knee arthroplasty | 24 | 12.3 8.2–18.2ROR 12.4 · χ² 237 / p 9e-54 | 11.6 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 87% (drug 63%) | no trial data cached |
| Febrile neutropenia | 74 | 11.9 9.5–14.9ROR 12.3 · χ² 729 / p 6e-161 | 11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · ♀ 26% (drug 63%) · 96% clinician | no trial data cached |
| Limb injury | 28 | 11.0 7.6–15.9ROR 11.2 · χ² 245 / p 2e-55 | 10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 93% (drug 63%) | no trial data cached |
| Bacteraemia | 12 | 10.9 6.2–19.1ROR 10.9 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Pneumonia aspiration | 25 | 10.7 7.2–15.8ROR 10.8 · χ² 210 / p 7e-48 | 9.9 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 29% (drug 63%) · 96% clinician | no trial data cached |
| Blood bilirubin increased | 27 | 10.6 7.3–15.4ROR 10.7 · χ² 226 / p 3e-51 | 9.9 EB05 6.9 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 · ♀ 92% (drug 63%) · 96% clinician | no trial data cached |
| Joint stiffness | 26 | 10.5 7.2–15.5ROR 10.7 · χ² 215 / p 5e-49 | 9.8 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · ♀ 92% (drug 63%) | no trial data cached |
| Anaemia (low red blood cells) | 189 | 10.5 9.2–12.1ROR 11.6 · χ² 1,637 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 90% (drug 63%) | no trial data cached |
| Arthropathy | 55 | 10.5 8.1–13.6ROR 10.8 · χ² 464 / p 3e-103 | 10.2 EB05 8.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 96% (drug 63%) | no trial data cached |
| Dysstasia | 27 | 9.8 6.7–14.3ROR 9.9 · χ² 205 / p 8e-47 | 9.0 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · ♀ 96% (drug 63%) | no trial data cached |
| Constipation | 196 | 9.6 8.4–11.0ROR 10.6 · χ² 1,524 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 89% (drug 63%) | no trial data cached |
| Pyrexia (fever) | 309 | 9.5 8.6–10.5ROR 11.1 · χ² 2,380 / p <1e-300 | 9.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Weight decreased (weight loss) | 238 | 9.1 8.1–10.2ROR 10.2 · χ² 1,725 / p <1e-300 | 9.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 89% (drug 63%) | 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) | 520 | 4.2 3.9–4.5ROR 5.4 · χ² 1,350 / p 6e-296 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · ♀ 95% (drug 63%) | no trial data cached |
| Macular degeneration | 460 | 427.3 393.6–463.9ROR 557.1 · χ² 187,683 / p <1e-300 | 403.7 EB05 373.7 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 299.6 · ♀ 100% (drug 63%) | no trial data cached |
| Pyrexia (fever) | 309 | 9.5 8.6–10.5ROR 11.1 · χ² 2,380 / p <1e-300 | 9.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Pain | 286 | 4.9 4.4–5.5ROR 5.6 · χ² 923 / p 4e-203 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Malaise (feeling unwell) | 263 | 6.4 5.7–7.1ROR 7.2 · χ² 1,210 / p 3e-265 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Weight decreased (weight loss) | 238 | 9.1 8.1–10.2ROR 10.2 · χ² 1,725 / p <1e-300 | 9.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 89% (drug 63%) | no trial data cached |
| Therapeutic product effect incomplete | 214 | 32.3 28.4–36.7ROR 36.1 · χ² 6,460 / p <1e-300 | 32.1 EB05 28.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 40.8 · ♀ 99% (drug 63%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 201 | 32.5 28.5–37.0ROR 36.0 · χ² 6,099 / p <1e-300 | 32.3 EB05 28.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · ♀ 98% (drug 63%) | no trial data cached |
| Dyspepsia (indigestion) | 199 | 21.6 19.0–24.7ROR 23.9 · χ² 3,904 / p <1e-300 | 21.5 EB05 19.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.7 · ♀ 97% (drug 63%) | no trial data cached |
| Paraesthesia oral | 198 | 148.6 130.1–169.8ROR 165.1 · χ² 28,500 / p <1e-300 | 144.5 EB05 128.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 176.1 · ♀ 100% (drug 63%) | no trial data cached |
| Constipation | 196 | 9.6 8.4–11.0ROR 10.6 · χ² 1,524 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 89% (drug 63%) | no trial data cached |
| Procedural pain | 190 | 73.6 64.3–84.3ROR 81.3 · χ² 13,455 / p <1e-300 | 72.6 EB05 64.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.1 · ♀ 100% (drug 63%) | no trial data cached |
| Anaemia (low red blood cells) | 189 | 10.5 9.2–12.1ROR 11.6 · χ² 1,637 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 90% (drug 63%) | no trial data cached |
| Abdominal pain | 188 | 8.6 7.5–9.9ROR 9.4 · χ² 1,270 / p 2e-278 | 8.5 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 92% (drug 63%) | no trial data cached |
| Erythema (skin redness) | 169 | 8.8 7.6–10.1ROR 9.5 · χ² 1,165 / p 1e-255 | 8.6 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · ♀ 93% (drug 63%) | 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 Zinc Oxide Ointment?
In FDA FAERS, the most frequently co-reported reaction terms for Zinc Oxide Ointment are macular degeneration, pyrexia, pain, malaise, weight decreased, infusion related reaction. 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 Zinc Oxide Ointment have an FDA boxed warning?
No. The FDA label retrieved for Zinc Oxide Ointment has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zinc Oxide Ointment 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 37eff762-1ea9-ec66-e063-6394a90a3d10, effective 20250619; matched on
openfda.generic_name.exact:"ZINC OXIDE OINTMENT") - 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, 108 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.