Drug · FAERS side-effect profile with label screen
Zinc Oxide side effects: what 2,063 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,063 reports · 84% serious · 211 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Helps prevent sunburn. Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
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. 79 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 | 408.2 375.9–443.4ROR 525.1 · χ² 179,273 / p <1e-300 | 386.0 EB05 357.3 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 291.5 · ♀ 100% (drug 63%) | no trial data cached |
| Vaginal discharge | 147 | 150.9 129.0–176.6ROR 162.5 · χ² 21,435 / p <1e-300 | 145.9 EB05 127.2 · 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 | 199 | 142.7 124.9–163.0ROR 157.8 · χ² 27,490 / p <1e-300 | 138.9 EB05 123.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 172.2 · ♀ 100% (drug 63%) | no trial data cached |
| Oral candidiasis (oral thrush) | 149 | 117.8 100.8–137.6ROR 126.8 · χ² 16,943 / p <1e-300 | 114.7 EB05 100.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.5 · ♀ 100% (drug 63%) | no trial data cached |
| Procedural pain | 190 | 70.3 61.4–80.5ROR 77.3 · χ² 12,839 / p <1e-300 | 69.4 EB05 61.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.8 · ♀ 100% (drug 63%) | no trial data cached |
| Frequent bowel movements | 152 | 57.7 49.5–67.3ROR 62.3 · χ² 8,382 / p <1e-300 | 57.0 EB05 49.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.2 · ♀ 98% (drug 63%) | no trial data cached |
| Colitis | 150 | 40.6 34.8–47.4ROR 43.7 · χ² 5,747 / p <1e-300 | 40.3 EB05 35.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.0 · ♀ 98% (drug 63%) | no trial data cached |
| Rectal haemorrhage | 164 | 38.8 33.5–45.0ROR 42.1 · χ² 5,992 / p <1e-300 | 38.5 EB05 33.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · ♀ 96% (drug 63%) | no trial data cached |
| Colitis ulcerative | 151 | 34.5 29.6–40.3ROR 37.2 · χ² 4,876 / p <1e-300 | 34.3 EB05 29.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.3 · ♀ 99% (drug 63%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 201 | 31.0 27.2–35.4ROR 34.3 · χ² 5,810 / p <1e-300 | 30.8 EB05 27.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · ♀ 98% (drug 63%) | no trial data cached |
| Therapeutic product effect incomplete | 215 | 31.0 27.3–35.2ROR 34.5 · χ² 6,213 / p <1e-300 | 30.8 EB05 27.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 39.8 · ♀ 99% (drug 63%) | no trial data cached |
| Accident | 36 | 30.8 22.3–42.6ROR 31.4 · χ² 1,007 / p 3e-221 | 30.3 EB05 22.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.2 · ♀ 0% (drug 63%) · 97% clinician | no trial data cached |
| Haematochezia (blood in stool) | 159 | 29.4 25.3–34.2ROR 31.8 · χ² 4,334 / p <1e-300 | 29.2 EB05 25.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · ♀ 99% (drug 63%) | no trial data cached |
| Nephropathy | 24 | 26.1 17.5–38.8ROR 26.4 · χ² 552 / p 2e-122 | 25.5 EB05 18.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 · ♀ 100% (drug 63%) | no trial data cached |
| Body height decreased | 24 | 22.6 15.2–33.7ROR 22.9 · χ² 474 / p 3e-105 | 22.2 EB05 15.7 · 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 | 21.9 16.2–29.5ROR 22.3 · χ² 815 / p 1e-179 | 21.7 EB05 16.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 7% (drug 63%) · 90% clinician | no trial data cached |
| Dyspepsia (indigestion) | 197 | 20.4 17.9–23.4ROR 22.5 · χ² 3,634 / p <1e-300 | 20.4 EB05 18.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.6 · ♀ 98% (drug 63%) | no trial data cached |
| Body temperature increased | 39 | 19.4 14.2–26.5ROR 19.8 · χ² 662 / p 3e-146 | 19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 16.4 · ♀ 5% (drug 63%) · 97% clinician | no trial data cached |
| Schizophrenia | 22 | 18.4 12.1–27.9ROR 18.6 · χ² 345 / p 3e-77 | 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 13.1 · ♀ 100% (drug 63%) · 100% clinician | no trial data cached |
| Obesity | 28 | 17.9 12.4–25.8ROR 18.1 · χ² 429 / p 2e-95 | 17.6 EB05 12.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · ♀ 100% (drug 63%) | no trial data cached |
| Joint range of motion decreased | 23 | 17.5 11.7–26.3ROR 17.7 · χ² 341 / p 2e-76 | 17.1 EB05 11.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 · ♀ 100% (drug 63%) | no trial data cached |
| Sciatica | 27 | 17.3 11.9–25.2ROR 17.5 · χ² 399 / p 5e-89 | 17.0 EB05 12.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · ♀ 100% (drug 63%) | no trial data cached |
| Cholelithiasis | 47 | 14.6 11.0–19.4ROR 14.9 · χ² 581 / p 1e-128 | 14.4 EB05 11.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · ♀ 96% (drug 63%) | no trial data cached |
| Hepatic steatosis | 26 | 14.2 9.7–20.8ROR 14.4 · χ² 306 / p 7e-69 | 13.8 EB05 9.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 92% (drug 63%) | no trial data cached |
| Foot deformity | 15 | 13.8 8.3–22.8ROR 13.8 · χ² 165 / p 5e-38 | 12.7 EB05 7.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Synovitis | 24 | 13.5 9.1–20.1ROR 13.7 · χ² 266 / p 4e-60 | 13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · ♀ 100% (drug 63%) | no trial data cached |
| Hepatotoxicity (liver damage) | 27 | 12.4 8.5–18.0ROR 12.5 · χ² 271 / p 3e-61 | 11.8 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 · ♀ 88% (drug 63%) · 100% clinician | no trial data cached |
| Knee arthroplasty | 25 | 12.2 8.3–18.0ROR 12.3 · χ² 246 / p 1e-55 | 11.6 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · ♀ 88% (drug 63%) | no trial data cached |
| Febrile neutropenia | 76 | 11.7 9.4–14.6ROR 12.1 · χ² 733 / p 1e-161 | 11.5 EB05 9.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · ♀ 30% (drug 63%) · 96% clinician | no trial data cached |
| Limb injury | 29 | 10.9 7.6–15.6ROR 11.0 · χ² 251 / p 9e-57 | 10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 93% (drug 63%) | no trial data cached |
| Bacteraemia | 12 | 10.4 5.9–18.2ROR 10.4 · χ² 92 / p 4e-22 | 8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Anaemia (low red blood cells) | 191 | 10.2 8.9–11.7ROR 11.1 · χ² 1,585 / p <1e-300 | 10.1 EB05 8.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 90% (drug 63%) | no trial data cached |
| Blood bilirubin increased | 27 | 10.1 7.0–14.8ROR 10.3 · χ² 213 / p 1e-48 | 9.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 · ♀ 92% (drug 63%) · 96% clinician | no trial data cached |
| Joint stiffness | 26 | 10.1 6.9–14.8ROR 10.2 · χ² 204 / p 2e-46 | 9.3 EB05 6.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 92% (drug 63%) | no trial data cached |
| Arthropathy | 54 | 9.8 7.6–12.8ROR 10.1 · χ² 421 / p 7e-94 | 9.5 EB05 7.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · ♀ 98% (drug 63%) | no trial data cached |
| Pneumonia aspiration | 24 | 9.8 6.6–14.6ROR 9.9 · χ² 181 / p 2e-41 | 8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · ♀ 29% (drug 63%) · 96% clinician | no trial data cached |
| Dysstasia | 27 | 9.4 6.4–13.6ROR 9.5 · χ² 194 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 · ♀ 96% (drug 63%) | no trial data cached |
| Constipation | 195 | 9.2 8.0–10.5ROR 10.0 · χ² 1,424 / p <1e-300 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 90% (drug 63%) | no trial data cached |
| Pyrexia (fever) | 309 | 9.1 8.2–10.1ROR 10.5 · χ² 2,249 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Weight decreased (weight loss) | 243 | 8.9 7.9–10.0ROR 9.9 · χ² 1,708 / p <1e-300 | 8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 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) | 529 | 4.1 3.8–4.4ROR 5.1 · χ² 1,311 / p 2e-287 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 · ♀ 95% (drug 63%) | no trial data cached |
| Macular degeneration | 460 | 408.2 375.9–443.4ROR 525.1 · χ² 179,273 / p <1e-300 | 386.0 EB05 357.3 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 291.5 · ♀ 100% (drug 63%) | no trial data cached |
| Pyrexia (fever) | 309 | 9.1 8.2–10.1ROR 10.5 · χ² 2,249 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Pain | 290 | 4.8 4.3–5.3ROR 5.4 · χ² 892 / p 2e-196 | 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 | no trial data cached |
| Malaise (feeling unwell) | 264 | 6.1 5.5–6.8ROR 6.9 · χ² 1,146 / p 2e-251 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Weight decreased (weight loss) | 243 | 8.9 7.9–10.0ROR 9.9 · χ² 1,708 / p <1e-300 | 8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 89% (drug 63%) | no trial data cached |
| Therapeutic product effect incomplete | 215 | 31.0 27.3–35.2ROR 34.5 · χ² 6,213 / p <1e-300 | 30.8 EB05 27.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 39.8 · ♀ 99% (drug 63%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 201 | 31.0 27.2–35.4ROR 34.3 · χ² 5,810 / p <1e-300 | 30.8 EB05 27.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · ♀ 98% (drug 63%) | no trial data cached |
| Paraesthesia oral | 199 | 142.7 124.9–163.0ROR 157.8 · χ² 27,490 / p <1e-300 | 138.9 EB05 123.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 172.2 · ♀ 100% (drug 63%) | no trial data cached |
| Dyspepsia (indigestion) | 197 | 20.4 17.9–23.4ROR 22.5 · χ² 3,634 / p <1e-300 | 20.4 EB05 18.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.6 · ♀ 98% (drug 63%) | no trial data cached |
| Constipation | 195 | 9.2 8.0–10.5ROR 10.0 · χ² 1,424 / p <1e-300 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 90% (drug 63%) | no trial data cached |
| Abdominal pain | 191 | 8.4 7.3–9.6ROR 9.1 · χ² 1,242 / p 2e-272 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · ♀ 92% (drug 63%) | no trial data cached |
| Anaemia (low red blood cells) | 191 | 10.2 8.9–11.7ROR 11.1 · χ² 1,585 / p <1e-300 | 10.1 EB05 8.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 90% (drug 63%) | no trial data cached |
| Procedural pain | 190 | 70.3 61.4–80.5ROR 77.3 · χ² 12,839 / p <1e-300 | 69.4 EB05 61.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.8 · ♀ 100% (drug 63%) | no trial data cached |
| Erythema (skin redness) | 172 | 8.5 7.4–9.8ROR 9.2 · χ² 1,145 / p 3e-251 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.4 · ♀ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Zinc Oxide 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 have an FDA boxed warning?
No. The FDA label retrieved for Zinc Oxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zinc Oxide 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 005d0245-fe53-47e5-888b-683f58cd6d26, effective 20260303; matched on
openfda.generic_name.exact:"ZINC OXIDE") - 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, 119 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.