Drug · FAERS side-effect profile with label screen
Cefuroxime Axetil side effects: what 3,414 FDA adverse event reports show
Drug class
Cephalosporin antibacterial drug
FDA label, Indications wording
Who reports
3,414 reports · 77% serious · 262 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediat.
FDA label, Indications and Usage
What it is
Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration.
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
Labeled adverse reaction 4Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 193 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 163 | 91.0 78.2–105.8ROR 95.5 · χ² 14,211 / p <1e-300 | 88.8 EB05 77.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 70.0 · ♀ 36% (drug 64%) | no trial data cached |
| Full blood count abnormal | 134 | 79.0 66.9–93.4ROR 82.2 · χ² 10,119 / p <1e-300 | 77.2 EB05 66.8 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 77.8 · ♀ 31% (drug 64%) | no trial data cached |
| Vasculitis | 107 | 56.9 47.2–68.6ROR 58.7 · χ² 5,766 / p <1e-300 | 55.8 EB05 47.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 45.5 · ♀ 0% (drug 64%) | no trial data cached |
| Arteriosclerosis | 82 | 53.9 43.5–66.8ROR 55.2 · χ² 4,167 / p <1e-300 | 52.8 EB05 43.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 41.4 · ♀ 0% (drug 64%) | no trial data cached |
| Sleep disorder due to a general medical condition | 121 | 46.3 38.8–55.2ROR 47.9 · χ² 5,279 / p <1e-300 | 45.6 EB05 39.2 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 67.7 · ♀ 6% (drug 64%) | no trial data cached |
| Fibromyalgia | 172 | 43.8 37.8–50.7ROR 46.1 · χ² 7,106 / p <1e-300 | 43.3 EB05 38.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 42.7 · ♀ 99% (drug 64%) | no trial data cached |
| Nodule | 82 | 38.8 31.3–48.1ROR 39.7 · χ² 2,966 / p <1e-300 | 38.3 EB05 31.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 44.8 · ♀ 0% (drug 64%) | no trial data cached |
| Pulmonary fibrosis | 114 | 36.8 30.7–44.2ROR 38.1 · χ² 3,919 / p <1e-300 | 36.4 EB05 31.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 · ♀ 0% (drug 64%) | no trial data cached |
| Sleep apnoea syndrome | 99 | 31.9 26.3–38.8ROR 32.9 · χ² 2,924 / p <1e-300 | 31.6 EB05 26.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 100% (drug 64%) | no trial data cached |
| Cystitis | 156 | 30.1 25.8–35.1ROR 31.5 · χ² 4,347 / p <1e-300 | 29.9 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 · ♀ 97% (drug 64%) | no trial data cached |
| Haemoptysis | 121 | 26.7 22.4–31.8ROR 27.6 · χ² 2,957 / p <1e-300 | 26.5 EB05 22.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · ♀ 8% (drug 64%) | no trial data cached |
| Hypothyroidism | 113 | 21.9 18.2–26.2ROR 22.6 · χ² 2,224 / p <1e-300 | 21.7 EB05 18.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · ♀ 7% (drug 64%) | no trial data cached |
| Swollen tongue | 110 | 21.7 18.0–26.1ROR 22.4 · χ² 2,144 / p <1e-300 | 21.5 EB05 18.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.7 · ♀ 96% (drug 64%) | no trial data cached |
| Wheezing | 183 | 19.0 16.5–21.9ROR 20.1 · χ² 3,111 / p <1e-300 | 19.0 EB05 16.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · ♀ 38% (drug 64%) | no trial data cached |
| Fluid retention | 148 | 17.9 15.3–21.0ROR 18.7 · χ² 2,347 / p <1e-300 | 17.8 EB05 15.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 · ♀ 99% (drug 64%) · 70% consumer | no trial data cached |
| Hypoxia (low oxygen) | 101 | 17.7 14.6–21.5ROR 18.2 · χ² 1,576 / p <1e-300 | 17.6 EB05 14.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 10% (drug 64%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 114 | 15.9 13.3–19.0ROR 16.4 · χ² 1,576 / p <1e-300 | 15.8 EB05 13.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · ♀ 96% (drug 64%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 38 | 15.5 11.3–21.3ROR 15.7 · χ² 500 / p 4e-111 | 15.3 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 | no trial data cached |
| Bronchitis | 187 | 15.5 13.5–17.8ROR 16.3 · χ² 2,519 / p <1e-300 | 15.4 EB05 13.6 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.0 · ♀ 91% (drug 64%) | no trial data cached |
| Therapeutic product effect incomplete | 177 | 15.4 13.3–17.8ROR 16.2 · χ² 2,372 / p <1e-300 | 15.3 EB05 13.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 21.0 · ♀ 34% (drug 64%) | no trial data cached |
| Loss of personal independence in daily activities | 118 | 15.3 12.8–18.2ROR 15.8 · χ² 1,559 / p <1e-300 | 15.2 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 15% (drug 64%) | no trial data cached |
| Lung disorder | 117 | 14.7 12.3–17.6ROR 15.2 · χ² 1,481 / p <1e-300 | 14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · ♀ 6% (drug 64%) | no trial data cached |
| Anaphylactic shock | 61 | 14.6 11.4–18.8ROR 14.9 · χ² 761 / p 7e-168 | 14.5 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Tinnitus (ringing in the ears) | 108 | 14.4 12.0–17.4ROR 14.9 · χ² 1,338 / p 4e-293 | 14.3 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 90% (drug 64%) | no trial data cached |
| Productive cough (cough with phlegm) | 104 | 13.5 11.2–16.3ROR 13.9 · χ² 1,193 / p 1e-261 | 13.4 EB05 11.3 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.9 · ♀ 18% (drug 64%) | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 120 | 13.4 11.3–16.0ROR 13.9 · χ² 1,370 / p 3e-300 | 13.3 EB05 11.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 91% clinician | no trial data cached |
| Agitation | 154 | 12.9 11.0–15.0ROR 13.4 · χ² 1,675 / p <1e-300 | 12.8 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 95% (drug 64%) | no trial data cached |
| Clostridium difficile colitis | 22 | 12.7 8.4–19.3ROR 12.8 · χ² 226 / p 2e-51 | 12.0 EB05 8.0 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 · ♀ 100% (drug 64%) | no trial data cached |
| Hallucination (hallucinations) | 151 | 12.4 10.6–14.5ROR 12.9 · χ² 1,572 / p <1e-300 | 12.3 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 96% (drug 64%) · 70% consumer | no trial data cached |
| Dysphonia | 115 | 12.1 10.1–14.5ROR 12.5 · χ² 1,162 / p 6e-255 | 12.0 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 95% (drug 64%) | no trial data cached |
| Blood count abnormal | 30 | 12.0 8.4–17.1ROR 12.1 · χ² 291 / p 1e-65 | 11.5 EB05 8.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 · ♀ 87% (drug 64%) | no trial data cached |
| Swelling face | 120 | 11.3 9.5–13.5ROR 11.7 · χ² 1,124 / p 1e-246 | 11.2 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 97% (drug 64%) | no trial data cached |
| Asthma | 196 | 10.8 9.4–12.3ROR 11.3 · χ² 1,730 / p <1e-300 | 10.7 EB05 9.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 39% (drug 64%) | no trial data cached |
| End stage renal disease | 31 | 10.3 7.3–14.7ROR 10.4 · χ² 252 / p 4e-57 | 9.7 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Migraine | 159 | 10.3 8.9–12.0ROR 10.8 · χ² 1,331 / p 1e-291 | 10.2 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 96% (drug 64%) | no trial data cached |
| Drug intolerance | 154 | 9.8 8.4–11.5ROR 10.3 · χ² 1,218 / p 5e-267 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 · ♀ 97% (drug 64%) | no trial data cached |
| Stomatitis (mouth sores) | 96 | 9.7 8.0–11.9ROR 10.0 · χ² 744 / p 4e-164 | 9.5 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 100% (drug 64%) | no trial data cached |
| Clostridium difficile infection | 33 | 9.4 6.7–13.2ROR 9.4 · χ² 238 / p 5e-54 | 8.7 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Intestinal perforation | 17 | 9.3 5.8–15.0ROR 9.3 · χ² 118 / p 1e-27 | 8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 19 | 9.1 5.8–14.2ROR 9.1 · χ² 129 / p 4e-30 | 8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 340 | 3.2 2.9–3.6ROR 3.5 · χ² 543 / p 2e-120 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Anxiety | 323 | 7.0 6.3–7.7ROR 7.6 · χ² 1,663 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 279 | 3.0 2.7–3.4ROR 3.2 · χ² 388 / p 1e-86 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · ♀ 41% (drug 64%) | no trial data cached |
| Dizziness | 250 | 3.1 2.7–3.5ROR 3.2 · χ² 358 / p 3e-80 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 86% (drug 64%) | no trial data cached |
| Abdominal pain | 243 | 6.4 5.7–7.3ROR 6.8 · χ² 1,119 / p 1e-245 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · ♀ 91% (drug 64%) | no trial data cached |
| Rash | 233 | 3.3 2.9–3.7ROR 3.5 · χ² 379 / p 1e-84 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Malaise (feeling unwell) | 230 | 3.2 2.8–3.6ROR 3.4 · χ² 356 / p 1e-79 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 85% (drug 64%) | no trial data cached |
| Pruritus (itching) | 216 | 3.5 3.1–4.0ROR 3.7 · χ² 392 / p 1e-87 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Hypersensitivity (allergic reaction) | 212 | 7.0 6.2–8.0ROR 7.4 · χ² 1,099 / p 3e-241 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · ♀ 92% (drug 64%) | no trial data cached |
| Abdominal pain upper | 205 | 6.1 5.4–7.0ROR 6.5 · χ² 883 / p 2e-194 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · ♀ 94% (drug 64%) | no trial data cached |
| Pneumonia (lung infection) | 199 | 3.8 3.3–4.3ROR 4.0 · χ² 411 / p 1e-91 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.9 | no trial data cached |
| Asthma | 196 | 10.8 9.4–12.3ROR 11.3 · χ² 1,730 / p <1e-300 | 10.7 EB05 9.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 39% (drug 64%) | no trial data cached |
| Condition aggravated | 190 | 3.9 3.4–4.4ROR 4.0 · χ² 406 / p 1e-90 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · ♀ 26% (drug 64%) | no trial data cached |
| Pain in extremity | 190 | 4.0 3.4–4.5ROR 4.1 · χ² 422 / p 4e-94 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 31% (drug 64%) | no trial data cached |
| Urticaria (hives) | 188 | 6.9 6.0–8.0ROR 7.3 · χ² 957 / p 2e-210 | 6.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · ♀ 90% (drug 64%) | 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.
- Obstructive airways disorder — n=163, PRR 91.0
- Vasculitis — n=107, PRR 56.9
- Arteriosclerosis — n=82, PRR 53.9
- Fibromyalgia — n=172, PRR 43.8
- Nodule — n=82, PRR 38.8
- Pulmonary fibrosis — n=114, PRR 36.8
- Sleep apnoea syndrome — n=99, PRR 31.9
- Cystitis — n=156, PRR 30.1
- Haemoptysis — n=121, PRR 26.7
- Hypothyroidism — n=113, PRR 21.9
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 Cefuroxime Axetil?
In FDA FAERS, the most frequently co-reported reaction terms for Cefuroxime Axetil are diarrhoea, anxiety, dyspnoea, dizziness, abdominal pain, rash. 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 Cefuroxime Axetil have an FDA boxed warning?
No. The FDA label retrieved for Cefuroxime Axetil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefuroxime Axetil 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 15cabe73-f39d-4798-a840-115fe94f8f96, effective 20250313; matched on
openfda.generic_name.exact:"CEFUROXIME AXETIL") - 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, 233 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.