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cefuroxime Side Effects

Also known as: Ceftin, Zinacef

Analysis of 11,087 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

11,087

Death-Related

1,324

11.9% of reports

Hospitalizations

5,229

47.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DYSPNOEA
738
DRUG INEFFECTIVE
662
PNEUMONIA
607
PYREXIA
591
OFF LABEL USE
585
RENAL FAILURE
581
CHRONIC KIDNEY DISEASE
573
DIARRHOEA
573
ACUTE KIDNEY INJURY
561
ANXIETY
445
FATIGUE
438
CONDITION AGGRAVATED
436
NAUSEA
433
PAIN
419
RASH
397
VOMITING
395
HEADACHE
376
DRUG INTERACTION
361
DRUG HYPERSENSITIVITY
336
URINARY TRACT INFECTION
320

Who Reports Side Effects

Gender Distribution

Female 5,856 (57%)
Male 4,276 (42%)
Unknown 53

Age Distribution

0-17 692 (8%)
18-44 1,661 (20%)
45-64 2,559 (31%)
65-74 1,774 (22%)
75+ 1,558 (19%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,324 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 307
RENAL FAILURE 162
DYSPNOEA 156
PNEUMONIA 147
PYREXIA 142
SEPSIS 120
CONDITION AGGRAVATED 109
ACUTE KIDNEY INJURY 105
ANXIETY 105
DRUG INEFFECTIVE 96
DIARRHOEA 91
RESPIRATORY FAILURE 84
CHRONIC KIDNEY DISEASE 83
PRODUCTIVE COUGH 79
RENAL IMPAIRMENT 76
HAEMOPTYSIS 75
MULTI-ORGAN FAILURE 75
SEPTIC SHOCK 74
HYPOXIA 73
CARDIAC ARREST 72

Reactions in Hospitalization Reports

Top reactions in 5,229 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 475
PNEUMONIA 455
PYREXIA 446
DIARRHOEA 377
DRUG INEFFECTIVE 352
ACUTE KIDNEY INJURY 282
CONDITION AGGRAVATED 273
OFF LABEL USE 266
NAUSEA 260
VOMITING 253
RENAL FAILURE 245
SEPSIS 234
DRUG INTERACTION 227
ANXIETY 223
FATIGUE 218
URINARY TRACT INFECTION 210
PAIN 206
PULMONARY EMBOLISM 204
ASTHENIA 196
MALAISE 187

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What the FAERS Data Reveals About cefuroxime Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 11,087 voluntary reports linked to cefuroxime and its brand equivalents (Ceftin, Zinacef), spanning 2004 through 2025. Of those, 1,324 (11.9%) listed death as an outcome and 5,229 (47.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 42% male; age distribution skews toward 45-64, with 2,559 reports in that bracket. The single most reported reaction is dyspnoea with 738 submissions, followed by drug ineffective and pneumonia.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.