Drug · FAERS side-effect profile with label screen
Allantoin side effects: what 3,290 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,290 reports · 77% serious · 453 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Temporarily protects minor cuts, scrapes, burns Helps prevent and temporarily protects and helps relieve chaged, chapped, or cracked skin
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 2No label text to screen 34
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. 268 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 123 | 85.5 71.8–101.9ROR 88.8 · χ² 10,060 / p <1e-300 | 83.3 EB05 71.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.9 · ♀ 1% (drug 53%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 129 | 74.7 63.0–88.6ROR 77.8 · χ² 9,208 / p <1e-300 | 73.1 EB05 63.1 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.2 · ♀ 4% (drug 53%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 119 | 53.6 44.9–64.0ROR 55.6 · χ² 6,047 / p <1e-300 | 52.8 EB05 45.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.6 · ♀ 0% (drug 53%) · 96% clinician | no trial data cached |
| Bacterial infection | 108 | 37.3 31.0–44.9ROR 38.5 · χ² 3,761 / p <1e-300 | 36.9 EB05 31.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · ♀ 3% (drug 53%) · 95% clinician | no trial data cached |
| Incorrect route of product administration | 89 | 34.0 27.7–41.7ROR 34.9 · χ² 2,801 / p <1e-300 | 33.6 EB05 28.1 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 50.4 · ♀ 0% (drug 53%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 61 | 32.6 25.4–41.9ROR 33.2 · χ² 1,830 / p <1e-300 | 32.2 EB05 25.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · ♀ 5% (drug 53%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 135 | 31.0 26.3–36.6ROR 32.3 · χ² 3,877 / p <1e-300 | 30.7 EB05 26.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.0 · ♀ 0% (drug 53%) · 96% clinician | no trial data cached |
| Ascites | 134 | 29.2 24.7–34.5ROR 30.4 · χ² 3,608 / p <1e-300 | 29.0 EB05 25.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 3% (drug 53%) · 95% clinician | no trial data cached |
| Neuralgia | 110 | 29.1 24.2–34.9ROR 30.0 · χ² 2,942 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · ♀ 3% (drug 53%) · 94% clinician | no trial data cached |
| Ulcer | 62 | 24.9 19.5–31.9ROR 25.4 · χ² 1,395 / p <1e-300 | 24.7 EB05 19.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.4 · ♀ 7% (drug 53%) · 95% clinician | no trial data cached |
| Aspiration | 40 | 23.6 17.4–32.2ROR 23.9 · χ² 842 / p 2e-185 | 23.3 EB05 17.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 · ♀ 11% (drug 53%) · 92% clinician | no trial data cached |
| Gout | 65 | 23.2 18.2–29.5ROR 23.6 · χ² 1,352 / p 2e-296 | 22.9 EB05 18.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 · ♀ 7% (drug 53%) · 95% clinician | no trial data cached |
| Blood test abnormal | 49 | 22.3 16.9–29.5ROR 22.7 · χ² 975 / p 3e-214 | 22.1 EB05 17.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 25.4 · ♀ 0% (drug 53%) · 96% clinician | no trial data cached |
| Hypercholesterolaemia | 30 | 20.1 14.0–28.7ROR 20.2 · χ² 523 / p 5e-116 | 19.8 EB05 14.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 · ♀ 0% (drug 53%) · 93% clinician | no trial data cached |
| Pharmaceutical product complaint | 82 | 19.9 16.1–24.7ROR 20.4 · χ² 1,452 / p <1e-300 | 19.8 EB05 16.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 | no trial data cached |
| End stage renal disease | 57 | 19.8 15.3–25.6ROR 20.1 · χ² 996 / p 5e-219 | 19.6 EB05 15.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 · ♀ 0% (drug 53%) · 95% clinician | no trial data cached |
| Full blood count abnormal | 30 | 18.2 12.7–26.0ROR 18.4 · χ² 469 / p 2e-104 | 17.9 EB05 13.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 18.0 · ♀ 0% (drug 53%) · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 159 | 18.1 15.5–21.1ROR 19.0 · χ² 2,550 / p <1e-300 | 18.0 EB05 15.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 7% (drug 53%) · 96% clinician | no trial data cached |
| Drug toxicity | 39 | 18.1 13.2–24.7ROR 18.3 · χ² 610 / p 5e-135 | 17.8 EB05 13.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 97% clinician | no trial data cached |
| Anorexia | 35 | 17.1 12.3–23.8ROR 17.3 · χ² 514 / p 4e-114 | 16.9 EB05 12.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Micturition urgency | 29 | 16.4 11.4–23.5ROR 16.5 · χ² 402 / p 1e-89 | 16.0 EB05 11.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 0% (drug 53%) · 97% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 120 | 14.7 12.3–17.5ROR 15.2 · χ² 1,520 / p <1e-300 | 14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · ♀ 7% (drug 53%) · 94% clinician | no trial data cached |
| Blood cholesterol increased | 105 | 14.4 11.9–17.4ROR 14.8 · χ² 1,295 / p 7e-284 | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 15.8 · ♀ 11% (drug 53%) · 95% clinician | no trial data cached |
| Stress | 146 | 13.0 11.1–15.2ROR 13.5 · χ² 1,604 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 7% (drug 53%) · 91% clinician | no trial data cached |
| Dry mouth | 142 | 11.2 9.5–13.2ROR 11.7 · χ² 1,312 / p 1e-287 | 11.1 EB05 9.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 15% (drug 53%) · 90% clinician | no trial data cached |
| Economic problem | 27 | 11.2 7.7–16.3ROR 11.3 · χ² 240 / p 2e-54 | 10.5 EB05 7.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Diabetes mellitus | 128 | 10.7 9.0–12.7ROR 11.1 · χ² 1,115 / p 7e-245 | 10.5 EB05 9.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 7% (drug 53%) · 92% clinician | no trial data cached |
| Transaminases increased | 37 | 10.6 7.7–14.7ROR 10.8 · χ² 313 / p 2e-70 | 10.1 EB05 7.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · ♀ 9% (drug 53%) · 94% clinician | no trial data cached |
| Coronary artery disease | 49 | 10.3 7.8–13.5ROR 10.4 · χ² 400 / p 3e-89 | 9.9 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 · ♀ 9% (drug 53%) · 93% clinician | no trial data cached |
| Sleep disorder | 109 | 10.0 8.3–12.0ROR 10.3 · χ² 870 / p 1e-191 | 9.8 EB05 8.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · ♀ 6% (drug 53%) · 90% clinician | no trial data cached |
| Sepsis (blood infection) | 168 | 9.6 8.3–11.1ROR 10.1 · χ² 1,293 / p 2e-283 | 9.5 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 9% (drug 53%) · 94% clinician | no trial data cached |
| Mitral valve incompetence | 17 | 9.6 6.0–15.4ROR 9.6 · χ² 122 / p 1e-28 | 8.4 EB05 5.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Joint injury | 32 | 9.6 6.8–13.5ROR 9.6 · χ² 237 / p 1e-53 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 0% (drug 53%) · 97% clinician | no trial data cached |
| Thrombosis | 119 | 9.4 7.9–11.2ROR 9.7 · χ² 889 / p 1e-195 | 9.2 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 7% (drug 53%) · 91% clinician | no trial data cached |
| Abdominal distension (bloating) | 153 | 9.4 8.1–11.0ROR 9.8 · χ² 1,144 / p 4e-251 | 9.3 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 13% (drug 53%) | no trial data cached |
| Iron deficiency anaemia | 13 | 9.0 5.3–15.6ROR 9.1 · χ² 85 / p 2e-20 | 7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Cardiovascular disorder | 36 | 9.0 6.5–12.4ROR 9.1 · χ² 248 / p 4e-56 | 8.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 13% (drug 53%) · 97% clinician | no trial data cached |
| Sputum discoloured | 13 | 8.8 5.1–15.1ROR 8.8 · χ² 82 / p 7e-20 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Renal failure acute | 58 | 8.6 6.7–11.1ROR 8.7 · χ² 383 / p 2e-85 | 8.2 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 97% clinician | no trial data cached |
| General physical health deterioration | 154 | 8.6 7.3–10.0ROR 8.9 · χ² 1,025 / p 3e-225 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 6% (drug 53%) · 96% clinician | 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 |
|---|---|---|---|---|---|---|
| Nausea | 410 | 3.3 3.0–3.6ROR 3.6 · χ² 687 / p 1e-151 | 3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Vomiting | 289 | 3.9 3.5–4.4ROR 4.2 · χ² 644 / p 3e-142 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Condition aggravated | 239 | 5.1 4.5–5.7ROR 5.4 · χ² 783 / p 1e-172 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · ♀ 26% (drug 53%) | no trial data cached |
| Abdominal pain | 207 | 5.7 5.0–6.5ROR 6.0 · χ² 803 / p 7e-177 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · ♀ 22% (drug 53%) | no trial data cached |
| Somnolence (drowsiness) | 196 | 6.2 5.4–7.1ROR 6.6 · χ² 862 / p 1e-189 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 21% (drug 53%) | no trial data cached |
| Weight decreased (weight loss) | 177 | 4.0 3.5–4.7ROR 4.2 · χ² 408 / p 4e-91 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.6 · 79% consumer | no trial data cached |
| Anaemia (low red blood cells) | 175 | 5.9 5.1–6.8ROR 6.1 · χ² 705 / p 1e-155 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 · ♀ 25% (drug 53%) · 94% clinician | no trial data cached |
| Constipation | 169 | 5.0 4.3–5.8ROR 5.2 · χ² 540 / p 1e-119 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · ♀ 18% (drug 53%) | no trial data cached |
| Sepsis (blood infection) | 168 | 9.6 8.3–11.1ROR 10.1 · χ² 1,293 / p 2e-283 | 9.5 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 9% (drug 53%) · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 159 | 18.1 15.5–21.1ROR 19.0 · χ² 2,550 / p <1e-300 | 18.0 EB05 15.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 7% (drug 53%) · 96% clinician | no trial data cached |
| General physical health deterioration | 154 | 8.6 7.3–10.0ROR 8.9 · χ² 1,025 / p 3e-225 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 6% (drug 53%) · 96% clinician | no trial data cached |
| Abdominal distension (bloating) | 153 | 9.4 8.1–11.0ROR 9.8 · χ² 1,144 / p 4e-251 | 9.3 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 13% (drug 53%) | no trial data cached |
| Stress | 146 | 13.0 11.1–15.2ROR 13.5 · χ² 1,604 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 7% (drug 53%) · 91% clinician | no trial data cached |
| Blood glucose increased | 144 | 4.9 4.1–5.7ROR 5.0 · χ² 441 / p 3e-98 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 2.1 · 82% consumer | no trial data cached |
| Dry mouth | 142 | 11.2 9.5–13.2ROR 11.7 · χ² 1,312 / p 1e-287 | 11.1 EB05 9.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 15% (drug 53%) · 90% clinician | 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 Allantoin?
In FDA FAERS, the most frequently co-reported reaction terms for Allantoin are nausea, vomiting, abdominal pain, somnolence, weight decreased, anaemia. 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 Allantoin have an FDA boxed warning?
No. The FDA label retrieved for Allantoin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Allantoin 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 1ee15f84-0561-3cd2-e063-6394a90ab68e, effective 20240915; matched on
openfda.generic_name.exact:"ALLANTOIN") - 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, 308 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.