Cefuroxime side effects: what 11,364 FDA adverse event reports show
Drug class
Not stated in label
Who reports
11,364 reports · 90% serious · 1,361 with death outcome · 58% female
Used for
Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp.
What it is
DESCRIPTION Cefuroxime, USP is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula:
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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. 1,109 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Intermittent positive pressure breathing | 10 | 4,548.9 1,426.9–14,502.2ROR 4,552.9 · χ² 11,724 / p <1e-300 | 372.3 EB05 216.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Pulmonary vasculitis | 179 | 949.6 793.3–1,136.6ROR 964.8 · χ² 110,833 / p <1e-300 | 585.0 EB05 516.5 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=179 · ♀ 0% (drug 58%) | not reported in cached trials |
| Total lung capacity abnormal | 111 | 762.2 611.1–950.5ROR 769.7 · χ² 58,934 / p <1e-300 | 491.7 EB05 419.6 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=111 · ♀ 0% (drug 58%) | not reported in cached trials |
| Trimethylaminuria | 11 | 690.2 344.9–1,381.3ROR 690.9 · χ² 5,000 / p <1e-300 | 267.9 EB05 159.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Intestinal intraepithelial lymphocytes increased | 13 | 463.8 252.3–852.5ROR 464.3 · χ² 4,422 / p <1e-300 | 239.8 EB05 149.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Mastitis bacterial | 13 | 463.8 252.3–852.5ROR 464.3 · χ² 4,422 / p <1e-300 | 239.8 EB05 149.1 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | not reported in cached trials |
| Foetal anaemia | 25 | 433.2 280.2–669.9ROR 434.2 · χ² 8,362 / p <1e-300 | 276.2 EB05 196.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 58%) | not reported in cached trials |
| Spirometry abnormal | 104 | 397.6 321.8–491.1ROR 401.2 · χ² 33,438 / p <1e-300 | 307.9 EB05 261.4 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=104 · ♀ 0% (drug 58%) | not reported in cached trials |
| Capillaritis | 47 | 392.3 286.4–537.4ROR 393.9 · χ² 14,770 / p <1e-300 | 285.4 EB05 223.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 0% (drug 58%) | not reported in cached trials |
| Microvillous inclusion disease | 12 | 346.6 187.0–642.4ROR 347.0 · χ² 3,189 / p <1e-300 | 199.4 EB05 121.5 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Mite allergy | 95 | 323.1 260.0–401.6ROR 325.8 · χ² 25,633 / p <1e-300 | 260.2 EB05 219.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 0% (drug 58%) | not reported in cached trials |
| Retinal infarction | 30 | 255.1 174.2–373.6ROR 255.8 · χ² 6,438 / p <1e-300 | 196.0 EB05 143.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Probiotic therapy | 11 | 232.7 124.3–435.8ROR 233.0 · χ² 2,049 / p <1e-300 | 152.4 EB05 90.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Mycotic allergy | 94 | 231.8 187.1–287.0ROR 233.7 · χ² 18,954 / p <1e-300 | 197.5 EB05 166.2 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=94 · ♀ 0% (drug 58%) | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 81 | 231.0 183.5–290.9ROR 232.7 · χ² 16,258 / p <1e-300 | 195.7 EB05 162.5 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=81 · ♀ 0% (drug 58%) | not reported in cached trials |
| Neuritis | 165 | 221.7 188.8–260.4ROR 225.0 · χ² 32,125 / p <1e-300 | 193.4 EB05 169.8 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 0% (drug 58%) | not reported in cached trials |
| Congenital pneumonia | 10 | 216.6 112.5–417.2ROR 216.8 · χ² 1,730 / p <1e-300 | 141.9 EB05 82.4 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Dust allergy | 96 | 204.1 165.4–251.8ROR 205.8 · χ² 17,261 / p <1e-300 | 177.2 EB05 149.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=96 · ♀ 0% (drug 58%) | not reported in cached trials |
| Positive airway pressure therapy | 23 | 201.2 130.8–309.4ROR 201.6 · χ² 3,947 / p <1e-300 | 157.8 EB05 110.7 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=23 · 100% clinician | not reported in cached trials |
| Congenital cytomegalovirus infection | 14 | 193.0 111.3–334.7ROR 193.2 · χ² 2,247 / p <1e-300 | 141.4 EB05 89.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Cryptitis | 13 | 189.2 106.9–334.9ROR 189.5 · χ² 2,038 / p <1e-300 | 137.4 EB05 85.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Macular detachment | 20 | 167.7 106.1–265.0ROR 168.0 · χ² 2,884 / p <1e-300 | 134.2 EB05 91.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Parophthalmia | 19 | 160.8 100.6–257.0ROR 161.1 · χ² 2,627 / p <1e-300 | 129.0 EB05 87.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Conjunctivitis allergic | 104 | 141.2 115.8–172.3ROR 142.5 · χ² 13,308 / p <1e-300 | 128.1 EB05 108.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 0% (drug 58%) | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 139 | 136.4 114.9–161.9ROR 138.1 · χ² 17,258 / p <1e-300 | 124.8 EB05 108.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=139 · ♀ 0% (drug 58%) | not reported in cached trials |
| Spinal muscular atrophy | 18 | 132.1 81.9–213.0ROR 132.3 · χ² 2,062 / p <1e-300 | 109.2 EB05 73.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Soft tissue mass | 29 | 123.6 84.9–179.9ROR 123.9 · χ² 3,188 / p <1e-300 | 107.7 EB05 78.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Respiratory symptom | 173 | 121.4 104.2–141.5ROR 123.3 · χ² 19,262 / p <1e-300 | 112.5 EB05 99.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=172 · ♀ 0% (drug 58%) | not reported in cached trials |
| Pyroglutamic acidosis | 23 | 118.9 78.0–181.2ROR 119.1 · χ² 2,414 / p <1e-300 | 102.4 EB05 71.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Deafness congenital | 12 | 115.5 64.5–207.0ROR 115.6 · χ² 1,176 / p 6e-258 | 93.0 EB05 56.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Congenital tricuspid valve incompetence | 10 | 101.1 53.5–191.0ROR 101.2 · χ² 846 / p 2e-186 | 81.4 EB05 47.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Periventricular leukomalacia | 14 | 95.4 55.8–163.2ROR 95.5 · χ² 1,155 / p 2e-253 | 81.0 EB05 51.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Keratitis fungal | 10 | 95.3 50.5–179.9ROR 95.3 · χ² 799 / p 4e-176 | 77.6 EB05 45.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Renal graft infection | 11 | 91.8 50.1–168.2ROR 91.9 · χ² 856 / p 2e-188 | 76.3 EB05 45.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Stoma closure | 14 | 89.7 52.5–153.3ROR 89.8 · χ² 1,087 / p 1e-238 | 76.9 EB05 48.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Apoptosis | 13 | 80.2 46.0–139.7ROR 80.3 · χ² 899 / p 7e-198 | 69.3 EB05 43.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Merycism | 11 | 75.5 41.3–138.0ROR 75.6 · χ² 707 / p 5e-156 | 64.8 EB05 38.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Normochromic normocytic anaemia | 118 | 75.5 62.8–90.6ROR 76.3 · χ² 8,255 / p <1e-300 | 71.7 EB05 61.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=118 · ♀ 6% (drug 58%) | not reported in cached trials |
| Retinal toxicity | 40 | 75.4 55.0–103.4ROR 75.7 · χ² 2,750 / p <1e-300 | 70.1 EB05 53.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | not reported in cached trials |
| Anterior chamber inflammation | 23 | 75.1 49.5–114.0ROR 75.3 · χ² 1,545 / p <1e-300 | 68.3 EB05 47.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | 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 Cefuroxime 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).
- NCT01518192 — Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiologica (N=544, PHASE4; 2 AE terms posted; arms: Doxycycline; Cefuroxime Axetil; Controls)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 755 | 2.5 2.3–2.6ROR 2.6 · χ² 673 / p 1e-148 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 687 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.156 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Off label use (used outside approved label) | 621 | 1.3 1.2–1.4ROR 1.3 · χ² 50 / p 8e-13 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Pneumonia (lung infection) | 621 | 3.5 3.3–3.8ROR 3.7 · χ² 1,150 / p 2e-252 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.3 | not reported in cached trials |
| Pyrexia (fever) | 598 | 3.2 3.0–3.4ROR 3.3 · χ² 911 / p 2e-200 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 582 | 1.7 1.5–1.8ROR 1.7 · χ² 161 / p 4e-37 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Renal failure (kidney failure) | 582 | 8.1 7.4–8.7ROR 8.4 · χ² 3,598 / p <1e-300 | 8.0 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | not reported in cached trials |
| Chronic kidney disease | 573 | 13.9 12.8–15.0ROR 14.6 · χ² 6,814 / p <1e-300 | 13.8 EB05 12.9 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.9 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 570 | 6.9 6.4–7.5ROR 7.2 · χ² 2,895 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | not reported in cached trials |
| Nausea | 452 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.120 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | not reported in cached trials |
| Anxiety | 452 | 2.9 2.7–3.2ROR 3.0 · χ² 578 / p 5e-128 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | not reported in cached trials |
| Condition aggravated | 449 | 2.7 2.5–3.0ROR 2.8 · χ² 503 / p 1e-111 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · ♀ 31% (drug 58%) | not reported in cached trials |
| Fatigue (tiredness) | 446 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.112 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | not reported in cached trials |
| Pain | 426 | 1.3 1.2–1.4ROR 1.3 · χ² 26 / p 2e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | not reported in cached trials |
| Vomiting | 409 | 1.6 1.5–1.8ROR 1.6 · χ² 96 / p 6e-23 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
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.
- Pulmonary vasculitis — n=179, PRR 949.6
- Total lung capacity abnormal — n=111, PRR 762.2
- Foetal anaemia — n=25, PRR 433.2
- Capillaritis — n=47, PRR 392.3
- Mite allergy — n=95, PRR 323.1
- Retinal infarction — n=30, PRR 255.1
- Mycotic allergy — n=94, PRR 231.8
- Neuritis — n=165, PRR 221.7
- Dust allergy — n=96, PRR 204.1
- Macular detachment — n=20, PRR 167.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Cefuroxime are dyspnoea, pneumonia, pyrexia, diarrhoea, renal failure, chronic kidney disease. 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 have an FDA boxed warning?
No. The FDA label retrieved for Cefuroxime has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefuroxime 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 65daa2aa-cc4a-4eba-b7dc-7a151806865a, effective 20200414; matched on
openfda.generic_name.exact:"CEFUROXIME") - 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, 1,149 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
CEFUROXIME, results-bearing studies sorted by enrollment)
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.