Drug · FAERS side-effect profile with label screen
Cefuroxime Sodium side effects: what 1,202 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,202 reports · 97% serious · 157 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
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:
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) 1Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 27
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. 39 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 | 85 | 133.9 109.0–164.4ROR 144.0 · χ² 10,997 / p <1e-300 | 129.0 EB05 107.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 82.3 · ♀ 5% (drug 53%) | no trial data cached |
| Full blood count abnormal | 80 | 133.4 107.8–165.0ROR 142.8 · χ² 10,303 / p <1e-300 | 128.4 EB05 106.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 104.8 · ♀ 3% (drug 53%) | no trial data cached |
| Vasculitis | 81 | 122.0 98.8–150.7ROR 130.8 · χ² 9,541 / p <1e-300 | 117.9 EB05 97.9 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 77.8 · ♀ 0% (drug 53%) | no trial data cached |
| Arteriosclerosis | 58 | 108.0 83.9–138.9ROR 113.4 · χ² 6,006 / p <1e-300 | 103.7 EB05 83.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 66.1 · ♀ 2% (drug 53%) | no trial data cached |
| Sleep disorder due to a general medical condition | 74 | 80.2 64.3–100.0ROR 85.4 · χ² 5,686 / p <1e-300 | 78.3 EB05 64.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 94.2 · ♀ 0% (drug 53%) | no trial data cached |
| Pulmonary fibrosis | 86 | 78.8 64.3–96.7ROR 84.8 · χ² 6,508 / p <1e-300 | 77.2 EB05 64.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 47.3 · ♀ 0% (drug 53%) | no trial data cached |
| Nodule | 55 | 73.8 57.0–95.6ROR 77.3 · χ² 3,864 / p <1e-300 | 71.7 EB05 57.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 67.9 · ♀ 0% (drug 53%) | no trial data cached |
| Swollen tongue | 104 | 58.2 48.4–70.0ROR 63.6 · χ² 5,781 / p <1e-300 | 57.4 EB05 48.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 48.5 · ♀ 100% (drug 53%) | no trial data cached |
| Haemoptysis | 87 | 54.5 44.5–66.7ROR 58.6 · χ² 4,504 / p <1e-300 | 53.7 EB05 44.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · ♀ 3% (drug 53%) | no trial data cached |
| Anaphylactic shock | 70 | 47.8 38.0–60.0ROR 50.7 · χ² 3,154 / p <1e-300 | 47.1 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 · 91% clinician | no trial data cached |
| Hypothyroidism | 83 | 45.6 37.0–56.1ROR 48.9 · χ² 3,571 / p <1e-300 | 45.0 EB05 37.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 29.8 · ♀ 2% (drug 53%) | no trial data cached |
| Retinal detachment | 23 | 43.7 29.2–65.6ROR 44.6 · χ² 916 / p 1e-201 | 42.2 EB05 29.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 108 | 42.8 35.7–51.2ROR 46.9 · χ² 4,364 / p <1e-300 | 42.4 EB05 36.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.9 · ♀ 100% (drug 53%) | no trial data cached |
| Hypoxia (low oxygen) | 71 | 35.4 28.2–44.4ROR 37.5 · χ² 2,337 / p <1e-300 | 35.0 EB05 28.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · ♀ 4% (drug 53%) | no trial data cached |
| Dysphonia | 104 | 31.1 25.9–37.4ROR 34.0 · χ² 3,004 / p <1e-300 | 30.9 EB05 26.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 · ♀ 100% (drug 53%) | no trial data cached |
| Bronchospasm (airway tightening) | 24 | 29.3 19.7–43.5ROR 29.9 · χ² 627 / p 1e-138 | 28.7 EB05 20.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 | no trial data cached |
| Lung disorder | 82 | 29.3 23.7–36.1ROR 31.3 · χ² 2,212 / p <1e-300 | 29.0 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · ♀ 0% (drug 53%) | no trial data cached |
| Swelling face | 108 | 29.0 24.2–34.7ROR 31.8 · χ² 2,898 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 · ♀ 100% (drug 53%) | no trial data cached |
| Loss of personal independence in daily activities | 77 | 28.3 22.8–35.1ROR 30.2 · χ² 2,001 / p <1e-300 | 28.1 EB05 23.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · ♀ 2% (drug 53%) | no trial data cached |
| Productive cough (cough with phlegm) | 70 | 25.8 20.6–32.4ROR 27.4 · χ² 1,648 / p <1e-300 | 25.6 EB05 21.0 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 22.9 · ♀ 12% (drug 53%) | no trial data cached |
| Wheezing | 85 | 25.1 20.4–30.8ROR 26.9 · χ² 1,945 / p <1e-300 | 24.9 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 · ♀ 6% (drug 53%) | no trial data cached |
| Tachypnoea | 19 | 24.5 15.7–38.3ROR 24.9 · χ² 405 / p 3e-90 | 23.9 EB05 16.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Drug ineffective for unapproved indication | 67 | 21.0 16.6–26.5ROR 22.2 · χ² 1,258 / p 9e-276 | 20.9 EB05 17.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 28.0 · ♀ 100% (drug 53%) | no trial data cached |
| Therapeutic product effect incomplete | 84 | 20.7 16.9–25.5ROR 22.2 · χ² 1,562 / p <1e-300 | 20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 23.2 · ♀ 0% (drug 53%) | no trial data cached |
| Drug intolerance | 100 | 18.1 15.0–21.9ROR 19.7 · χ² 1,608 / p <1e-300 | 18.1 EB05 15.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 17.6 · ♀ 99% (drug 53%) | no trial data cached |
| Wrong technique in drug usage process | 38 | 18.0 13.2–24.6ROR 18.6 · χ² 594 / p 2e-131 | 17.8 EB05 13.5 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 35.5 · 100% clinician | no trial data cached |
| Circulatory collapse | 15 | 15.3 9.3–25.3ROR 15.5 · χ² 187 / p 9e-43 | 14.4 EB05 8.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Accidental overdose | 30 | 14.3 10.1–20.4ROR 14.7 · χ² 359 / p 2e-80 | 14.0 EB05 10.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 45 | 14.3 10.7–19.1ROR 14.8 · χ² 545 / p 1e-120 | 14.1 EB05 10.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 91% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 149 | 14.0 12.1–16.3ROR 15.9 · χ² 1,805 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.7 · ♀ 85% (drug 53%) | no trial data cached |
| Visual acuity reduced | 26 | 13.6 9.3–19.8ROR 13.8 · χ² 290 / p 2e-65 | 13.1 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · 100% clinician | no trial data cached |
| Asthma | 87 | 13.5 11.1–16.6ROR 14.5 · χ² 1,003 / p 2e-220 | 13.4 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 3% (drug 53%) | no trial data cached |
| Rash maculo-papular | 17 | 13.4 8.4–21.5ROR 13.6 · χ² 183 / p 6e-42 | 12.5 EB05 7.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Thrombosis | 58 | 12.5 9.8–16.1ROR 13.1 · χ² 607 / p 3e-134 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 2% (drug 53%) | no trial data cached |
| Pulmonary embolism (lung blood clot) | 63 | 11.5 9.1–14.7ROR 12.1 · χ² 597 / p 4e-132 | 11.3 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 6% (drug 53%) | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 10 | 11.1 6.0–20.5ROR 11.2 · χ² 82 / p 7e-20 | 9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Pallor | 17 | 10.9 6.8–17.4ROR 11.0 · χ² 143 / p 3e-33 | 9.7 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Drug-induced liver injury | 19 | 10.8 6.9–16.8ROR 10.9 · χ² 159 / p 1e-36 | 9.7 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Body temperature increased | 12 | 10.2 5.8–18.0ROR 10.3 · χ² 91 / p 7e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 10 | 7.8 4.2–14.5ROR 7.9 · χ² 53 / p 2e-13 | 6.1 EB05 3.5 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | 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 |
|---|---|---|---|---|---|---|
| Hypersensitivity (allergic reaction) | 149 | 14.0 12.1–16.3ROR 15.9 · χ² 1,805 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.7 · ♀ 85% (drug 53%) | no trial data cached |
| Swelling face | 108 | 29.0 24.2–34.7ROR 31.8 · χ² 2,898 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 · ♀ 100% (drug 53%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 108 | 42.8 35.7–51.2ROR 46.9 · χ² 4,364 / p <1e-300 | 42.4 EB05 36.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.9 · ♀ 100% (drug 53%) | no trial data cached |
| Dysphonia | 104 | 31.1 25.9–37.4ROR 34.0 · χ² 3,004 / p <1e-300 | 30.9 EB05 26.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 · ♀ 100% (drug 53%) | no trial data cached |
| Swollen tongue | 104 | 58.2 48.4–70.0ROR 63.6 · χ² 5,781 / p <1e-300 | 57.4 EB05 48.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 48.5 · ♀ 100% (drug 53%) | no trial data cached |
| Drug intolerance | 100 | 18.1 15.0–21.9ROR 19.7 · χ² 1,608 / p <1e-300 | 18.1 EB05 15.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 17.6 · ♀ 99% (drug 53%) | no trial data cached |
| Asthma | 87 | 13.5 11.1–16.6ROR 14.5 · χ² 1,003 / p 2e-220 | 13.4 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 3% (drug 53%) | no trial data cached |
| Haemoptysis | 87 | 54.5 44.5–66.7ROR 58.6 · χ² 4,504 / p <1e-300 | 53.7 EB05 44.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · ♀ 3% (drug 53%) | no trial data cached |
| Pulmonary fibrosis | 86 | 78.8 64.3–96.7ROR 84.8 · χ² 6,508 / p <1e-300 | 77.2 EB05 64.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 47.3 · ♀ 0% (drug 53%) | no trial data cached |
| Wheezing | 85 | 25.1 20.4–30.8ROR 26.9 · χ² 1,945 / p <1e-300 | 24.9 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 · ♀ 6% (drug 53%) | no trial data cached |
| Obstructive airways disorder | 85 | 133.9 109.0–164.4ROR 144.0 · χ² 10,997 / p <1e-300 | 129.0 EB05 107.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 82.3 · ♀ 5% (drug 53%) | no trial data cached |
| Therapeutic product effect incomplete | 84 | 20.7 16.9–25.5ROR 22.2 · χ² 1,562 / p <1e-300 | 20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 23.2 · ♀ 0% (drug 53%) | no trial data cached |
| Hypothyroidism | 83 | 45.6 37.0–56.1ROR 48.9 · χ² 3,571 / p <1e-300 | 45.0 EB05 37.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 29.8 · ♀ 2% (drug 53%) | no trial data cached |
| Lung disorder | 82 | 29.3 23.7–36.1ROR 31.3 · χ² 2,212 / p <1e-300 | 29.0 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · ♀ 0% (drug 53%) | no trial data cached |
| Vasculitis | 81 | 122.0 98.8–150.7ROR 130.8 · χ² 9,541 / p <1e-300 | 117.9 EB05 97.9 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 77.8 · ♀ 0% (drug 53%) | 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=85, PRR 133.9
- Arteriosclerosis — n=58, PRR 108.0
- Sleep disorder due to a general medical condition — n=74, PRR 80.2
- Pulmonary fibrosis — n=86, PRR 78.8
- Nodule — n=55, PRR 73.8
- Swollen tongue — n=104, PRR 58.2
- Haemoptysis — n=87, PRR 54.5
- Anaphylactic shock — n=70, PRR 47.8
- Hypothyroidism — n=83, PRR 45.6
- Retinal detachment — n=23, PRR 43.7
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 hypersensitivity, swelling face, angioedema, dysphonia, swollen tongue, asthma. 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, 79 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.