Drug · FAERS side-effect profile with label screen
Urea side effects: what 2,154 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,154 reports · 79% serious · 211 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hype.
FDA label, Indications and Usage
What it is
Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: This product is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram cont.
FDA label, Description section
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
Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 33
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 58 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 |
|---|---|---|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndrome | 83 | 34.7 28.1–42.8ROR 36.0 · χ² 2,673 / p <1e-300 | 34.3 EB05 28.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 27.4 | no trial data cached |
| Hypercholesterolaemia | 17 | 17.3 10.8–27.8ROR 17.5 · χ² 245 / p 2e-55 | 16.7 EB05 10.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Adrenal insufficiency | 19 | 15.5 9.9–24.2ROR 15.6 · χ² 243 / p 5e-55 | 14.9 EB05 9.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Helicobacter infection | 15 | 14.3 8.7–23.8ROR 14.4 · χ² 173 / p 9e-40 | 13.4 EB05 7.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Hepatic encephalopathy | 11 | 11.5 6.4–20.7ROR 11.5 · χ² 95 / p 1e-22 | 9.6 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Autoimmune disorder | 11 | 11.2 6.2–20.2ROR 11.3 · χ² 92 / p 4e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Generalised oedema | 13 | 10.3 6.0–17.7ROR 10.3 · χ² 100 / p 8e-24 | 8.7 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Folliculitis | 10 | 9.4 5.1–17.5ROR 9.5 · χ² 67 / p 1e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Pemphigus | 12 | 9.4 5.3–16.5ROR 9.5 · χ² 82 / p 7e-20 | 7.7 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Prescribed overdose | 18 | 9.1 5.7–14.4ROR 9.1 · χ² 121 / p 2e-28 | 7.9 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Sciatica | 14 | 8.6 5.1–14.5ROR 8.6 · χ² 87 / p 7e-21 | 7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Muscle atrophy | 11 | 8.5 4.7–15.4ROR 8.6 · χ² 66 / p 3e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Hypomagnesaemia | 12 | 8.4 4.8–14.8ROR 8.5 · χ² 71 / p 2e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Taste disorder | 17 | 8.3 5.1–13.3ROR 8.3 · χ² 101 / p 4e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Gait inability | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 171 / p 2e-39 | 7.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 91% (drug 50%) | no trial data cached |
| C-reactive protein increased | 30 | 8.0 5.6–11.5ROR 8.1 · χ² 178 / p 7e-41 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · ♀ 85% (drug 50%) · 93% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 15 | 7.7 4.7–12.8ROR 7.8 · χ² 81 / p 9e-20 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Hand deformity | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 50 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 17 | 7.4 4.6–11.9ROR 7.5 · χ² 88 / p 3e-21 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| End stage renal disease | 14 | 7.4 4.4–12.5ROR 7.4 · χ² 71 / p 2e-17 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Wound | 21 | 7.4 4.8–11.3ROR 7.4 · χ² 109 / p 8e-26 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Skin ulcer | 19 | 7.2 4.6–11.2ROR 7.2 · χ² 95 / p 1e-22 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Dermatitis | 15 | 7.1 4.3–11.7ROR 7.1 · χ² 72 / p 1e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.7 | no trial data cached |
| Lower limb fracture | 13 | 6.6 3.9–11.4ROR 6.7 · χ² 57 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Blood bilirubin increased | 18 | 6.5 4.1–10.3ROR 6.5 · χ² 78 / p 5e-19 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Hip arthroplasty | 10 | 6.4 3.5–11.9ROR 6.4 · χ² 40 / p 1e-10 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Skin fissures | 12 | 6.2 3.5–10.9ROR 6.2 · χ² 47 / p 3e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Pneumonitis | 17 | 6.1 3.8–9.8ROR 6.2 · χ² 68 / p 9e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Obesity | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Fibromyalgia | 15 | 6.0 3.6–10.0ROR 6.1 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Stomatitis (mouth sores) | 37 | 5.9 4.3–8.2ROR 6.0 · χ² 147 / p 3e-34 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 71% (drug 50%) | no trial data cached |
| Impaired healing | 20 | 5.9 3.8–9.2ROR 6.0 · χ² 77 / p 8e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Irritable bowel syndrome | 13 | 5.9 3.4–10.2ROR 6.0 · χ² 48 / p 2e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Prescribed underdose | 12 | 5.9 3.3–10.3ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Pericarditis | 10 | 5.8 3.1–10.8ROR 5.9 · χ² 35 / p 1e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Febrile neutropenia | 37 | 5.4 4.0–7.5ROR 5.5 · χ² 130 / p 2e-30 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 29% (drug 50%) · 92% clinician | no trial data cached |
| Synovitis | 10 | 5.4 2.9–10.0ROR 5.4 · χ² 32 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Blood glucose abnormal | 10 | 5.3 2.8–9.8ROR 5.3 · χ² 30 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 | no trial data cached |
| Blood cholesterol increased | 25 | 5.2 3.5–7.7ROR 5.3 · χ² 81 / p 1e-19 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · ♀ 100% (drug 50%) · 96% clinician | no trial data cached |
| Oral pain | 12 | 5.2 3.0–9.1ROR 5.2 · χ² 37 / p 7e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | 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 |
|---|---|---|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndrome | 83 | 34.7 28.1–42.8ROR 36.0 · χ² 2,673 / p <1e-300 | 34.3 EB05 28.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 27.4 | no trial data cached |
| Psoriasis | 45 | 3.4 2.5–4.5ROR 3.4 · χ² 72 / p 9e-18 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.3 | no trial data cached |
| Skin exfoliation | 43 | 5.0 3.7–6.8ROR 5.1 · χ² 136 / p 1e-31 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Febrile neutropenia | 37 | 5.4 4.0–7.5ROR 5.5 · χ² 130 / p 2e-30 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 29% (drug 50%) · 92% clinician | no trial data cached |
| Stomatitis (mouth sores) | 37 | 5.9 4.3–8.2ROR 6.0 · χ² 147 / p 3e-34 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 71% (drug 50%) | no trial data cached |
| Dry skin | 36 | 2.7 1.9–3.7ROR 2.7 · χ² 36 / p 1e-9 | 2.6 EB05 2.0 · IC025 +0.8 | Likely indication confounding term in indications | serious PRR 4.7 | no trial data cached |
| C-reactive protein increased | 30 | 8.0 5.6–11.5ROR 8.1 · χ² 178 / p 7e-41 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · ♀ 85% (drug 50%) · 93% clinician | no trial data cached |
| Malignant neoplasm progression | 28 | 2.7 1.9–3.9ROR 2.7 · χ² 28 / p 6e-8 | 2.6 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Gait inability | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 171 / p 2e-39 | 7.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 91% (drug 50%) | no trial data cached |
| Blood cholesterol increased | 25 | 5.2 3.5–7.7ROR 5.3 · χ² 81 / p 1e-19 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · ♀ 100% (drug 50%) · 96% clinician | no trial data cached |
| Arthropathy | 24 | 4.2 2.8–6.2ROR 4.2 · χ² 55 / p 5e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 95% (drug 50%) | no trial data cached |
| Psoriatic arthropathy | 21 | 5.1 3.3–7.8ROR 5.1 · χ² 65 / p 4e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.2 · 95% clinician | no trial data cached |
| Wound | 21 | 7.4 4.8–11.3ROR 7.4 · χ² 109 / p 8e-26 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Impaired healing | 20 | 5.9 3.8–9.2ROR 6.0 · χ² 77 / p 8e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Neutrophil count decreased | 19 | 4.6 2.9–7.1ROR 4.6 · χ² 50 / p 1e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Gait inability — n=28, PRR 8.2
- Wound — n=21, PRR 7.4
- Stomatitis — n=37, PRR 5.9
- Febrile neutropenia — n=37, PRR 5.4
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 Urea?
In FDA FAERS, the most frequently co-reported reaction terms for Urea are palmar-plantar erythrodysaesthesia syndrome, psoriasis, skin exfoliation, febrile neutropenia, stomatitis, dry skin. 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 Urea have an FDA boxed warning?
No. The FDA label retrieved for Urea has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Urea 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 0fa4445e-554c-c791-e063-6294a90a9713, effective 20240123; matched on
openfda.generic_name.exact:"UREA") - 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, 98 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.