Drug · FAERS side-effect profile with label screen
Zinc Gluconate side effects: what 25,970 FDA adverse event reports show
Drug class
Not stated in label
Who reports
25,970 reports · 57% serious · 1,584 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
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 4Lab value / disease marker 4No label text to screen 32
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,158 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 |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 52 | 3,445.4 1,839.4–6,453.5ROR 3,452.3 · calibrated p 1e-20 ✓ | 521.9 EB05 413.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Radiation inflammation | 28 | 428.1 270.5–677.7ROR 428.6 · calibrated p 4e-12 ✓ | 234.2 EB05 170.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 66%) | not reported in cached trials |
| Copper deficiency | 21 | 179.5 111.8–288.2ROR 179.7 · calibrated p 7e-9 ✓ | 129.6 EB05 89.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | not reported in cached trials |
| Sedation complication | 314 | 115.9 103.0–130.4ROR 117.3 · calibrated p 4e-8 ✓ | 100.7 EB05 91.7 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=314 · ♀ 100% (drug 66%) | not reported in cached trials |
| Rhinocerebral mucormycosis | 30 | 77.4 53.2–112.6ROR 77.5 · calibrated p 2e-6 ✓ | 67.7 EB05 49.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 100% clinician | not reported in cached trials |
| Multiple drug therapy | 61 | 77.2 59.4–100.4ROR 77.4 · calibrated p 1e-6 ✓ | 69.0 EB05 55.7 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=61 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance decreased | 322 | 70.0 62.5–78.4ROR 70.9 · calibrated p 1e-6 ✓ | 64.2 EB05 58.5 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=322 · ♀ 100% (drug 66%) | not reported in cached trials |
| Carbuncle | 21 | 64.7 41.5–100.9ROR 64.8 · calibrated p 7e-6 ✓ | 57.0 EB05 39.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 66%) | not reported in cached trials |
| Creatinine renal clearance increased | 50 | 57.4 43.1–76.5ROR 57.6 · calibrated p 8e-6 ✓ | 52.6 EB05 41.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=50 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Appendicolith | 24 | 54.4 36.0–82.2ROR 54.4 · calibrated p 2e-5 ✓ | 49.1 EB05 34.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Necrosis ischaemic | 21 | 38.3 24.7–59.3ROR 38.3 · calibrated p 1e-4 ✓ | 35.5 EB05 24.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Pulmonary pain | 105 | 30.6 25.2–37.2ROR 30.7 · calibrated p 3e-4 ✓ | 29.4 EB05 24.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 | not reported in cached trials |
| Blood calcium decreased | 359 | 26.5 23.9–29.4ROR 26.8 · calibrated p 5e-4 ✓ | 25.6 EB05 23.5 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 31.5 · ♀ 97% (drug 66%) | not reported in cached trials |
| Sinusitis fungal | 25 | 26.4 17.7–39.3ROR 26.4 · calibrated p 8e-4 ✓ | 25.1 EB05 17.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 100% clinician | not reported in cached trials |
| Genital ulceration | 22 | 24.1 15.8–36.9ROR 24.1 · calibrated p 0.001 ✓ | 23.0 EB05 16.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | not reported in cached trials |
| Facet joint syndrome | 89 | 23.4 19.0–28.9ROR 23.5 · calibrated p 0.001 ✓ | 22.7 EB05 19.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · ♀ 100% (drug 66%) | not reported in cached trials |
| Peripheral venous disease | 112 | 23.3 19.3–28.0ROR 23.3 · calibrated p 0.001 ✓ | 22.5 EB05 19.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 · ♀ 100% (drug 66%) | not reported in cached trials |
| Monoclonal immunoglobulin present | 21 | 22.7 14.7–35.1ROR 22.8 · calibrated p 0.002 ✓ | 21.7 EB05 14.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 100% (drug 66%) | not reported in cached trials |
| Onychomycosis | 116 | 21.9 18.2–26.4ROR 22.0 · calibrated p 0.001 ✓ | 21.3 EB05 18.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 · ♀ 100% (drug 66%) | not reported in cached trials |
| Infusion site discharge | 43 | 20.8 15.4–28.1ROR 20.8 · calibrated p 0.002 ✓ | 20.1 EB05 15.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · 100% consumer | not reported in cached trials |
| Onychomadesis | 96 | 19.1 15.6–23.3ROR 19.1 · calibrated p 0.003 ✓ | 18.6 EB05 15.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 21 | 18.9 12.3–29.1ROR 18.9 · calibrated p 0.004 ✓ | 18.1 EB05 12.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | not reported in cached trials |
| Rheumatic fever | 100 | 18.9 15.5–23.0ROR 18.9 · calibrated p 0.003 ✓ | 18.4 EB05 15.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Finger deformity | 107 | 18.2 15.0–22.0ROR 18.3 · calibrated p 0.003 ✓ | 17.7 EB05 15.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 66%) | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 359 | 16.9 15.3–18.8ROR 17.1 · calibrated p 0.004 ✓ | 16.6 EB05 15.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 95% (drug 66%) | not reported in cached trials |
| Pneumonia streptococcal | 22 | 16.5 10.8–25.1ROR 16.5 · calibrated p 0.007 ✓ | 15.7 EB05 10.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Female genital tract fistula | 32 | 15.3 10.8–21.6ROR 15.3 · calibrated p 0.008 ✓ | 14.7 EB05 10.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Beta haemolytic streptococcal infection | 23 | 15.0 10.0–22.7ROR 15.1 · calibrated p 0.009 ✓ | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Renal function test abnormal | 84 | 15.0 12.1–18.6ROR 15.1 · calibrated p 0.007 ✓ | 14.7 EB05 12.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=79 · ♀ 100% (drug 66%) | not reported in cached trials |
| Hypothalamo-pituitary disorder | 26 | 14.8 10.0–21.8ROR 14.8 · calibrated p 0.010 ✓ | 14.1 EB05 9.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 66%) | not reported in cached trials |
| Macrocytosis | 21 | 14.8 9.6–22.7ROR 14.8 · calibrated p 0.010 ✓ | 14.0 EB05 9.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | not reported in cached trials |
| Sinus pain | 41 | 14.6 10.7–19.9ROR 14.6 · calibrated p 0.009 ✓ | 14.1 EB05 10.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 66%) | not reported in cached trials |
| Congenital anomaly | 134 | 14.1 11.9–16.7ROR 14.2 · calibrated p 0.009 ✓ | 13.8 EB05 11.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Product label confusion | 97 | 13.7 11.2–16.7ROR 13.7 · calibrated p 0.011 ✓ | 13.4 EB05 11.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=97 · ♀ 100% (drug 66%) | not reported in cached trials |
| Genital pain | 24 | 13.3 8.9–19.9ROR 13.3 · calibrated p 0.015 ✓ | 12.5 EB05 8.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 0% (drug 66%) | not reported in cached trials |
| Infusion site bruising | 34 | 13.1 9.3–18.4ROR 13.1 · calibrated p 0.014 ✓ | 12.5 EB05 9.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 100% consumer | not reported in cached trials |
| Blepharospasm | 95 | 12.5 10.2–15.3ROR 12.6 · calibrated p 0.015 ✓ | 12.2 EB05 10.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 100% (drug 66%) | not reported in cached trials |
| Nail disorder | 123 | 11.6 9.7–13.8ROR 11.6 · calibrated p 0.020 ✓ | 11.3 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=116 · ♀ 91% (drug 66%) | not reported in cached trials |
| Breast cancer stage iii | 88 | 11.2 9.1–13.8ROR 11.2 · calibrated p 0.023 ✓ | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Sedation | 349 | 10.9 9.8–12.1ROR 11.1 · calibrated p 0.023 ✓ | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 · ♀ 100% (drug 66%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Zinc Gluconate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT05085834 — Zinc Effect on Inflammation and Cardiovascular Risk in HIV (N=95, EARLY_PHASE1; 29 AE terms posted; arms: Zinc Gluconate; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,763 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.595 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Pain | 1,988 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.715 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | NCT05085834: 1/63 (1.6%) on Zinc Gluconate |
| Nausea | 1,985 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.993 | 2.0 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | NCT05085834: 8/63 (12.7%) on Zinc Gluconate |
| Diarrhoea (diarrhea) | 1,984 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.765 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | NCT05085834: 1/63 (1.6%) on Zinc Gluconate |
| Off label use (used outside approved label) | 1,889 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.840 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.2 | not reported in cached trials |
| Headache | 1,884 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.795 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,598 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.292 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,536 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.918 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Arthralgia (joint pain) | 1,384 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.696 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | not reported in cached trials |
| Dizziness | 1,375 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.903 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | NCT05085834: 1/63 (1.6%) on Zinc Gluconate |
| Asthenia (weakness) | 1,304 | 2.8 2.7–3.0ROR 2.9 · calibrated p 0.660 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | not reported in cached trials |
| Fall | 1,290 | 3.1 3.0–3.3ROR 3.3 · calibrated p 0.551 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | not reported in cached trials |
| Constipation | 1,149 | 4.3 4.1–4.6ROR 4.5 · calibrated p 0.303 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | not reported in cached trials |
| Rash | 1,127 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.977 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | not reported in cached trials |
| Vomiting | 1,038 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.842 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | not reported in cached trials |
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 Gluconate?
In FDA FAERS, the most frequently co-reported reaction terms for Zinc Gluconate are fatigue, pain, nausea, diarrhoea, headache, dyspnoea. 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 Gluconate have an FDA boxed warning?
No. The FDA label retrieved for Zinc Gluconate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zinc Gluconate 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 04b6992d-c7c5-56c7-e063-6394a90ae8d0, effective 20260501; matched on
openfda.generic_name.exact:"ZINC GLUCONATE") - 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, 1,198 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 - ClinicalTrials.gov API v2 (query
ZINC GLUCONATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.