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Drug side effects

cefazolin Side Effects

The reactions most often reported to the FDA for cefazolin (also sold as Ancef, Kefzol), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

8,788
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of cefazolin come from 8,788 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 8,788 reports to the FDA Adverse Event Reporting System (FAERS) for cefazolin (Ancef): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

8,788

Reports Mentioning Death

1,005

11.4% of reports — not proof the medicine caused the death

Hospitalizations

4,522

51.5% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

HYPOTENSION
542
ANAPHYLACTIC REACTION
470
RASH
454
RENAL FAILURE
435
PAIN
385
PYREXIA
371
ACUTE KIDNEY INJURY
360
ANAPHYLACTIC SHOCK
325
DRUG HYPERSENSITIVITY
303
ANXIETY
296
NAUSEA
279
URTICARIA
273
DYSPNOEA
255
INJURY
239
DRUG INTERACTION
235
CARDIAC ARREST
230
UNEVALUABLE EVENT
229
VOMITING
220

Who Reports Side Effects

Gender Distribution

Female 3,959 (49%)
Male 4,092 (51%)
Unknown 34

Age Distribution

0-17 622 (9%)
18-44 1,607 (23%)
45-64 2,325 (33%)
65-74 1,478 (21%)
75+ 1,088 (15%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,005 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 180
RENAL FAILURE 176
PAIN 132
INJURY 118
ANXIETY 110
UNEVALUABLE EVENT 103
MULTI-ORGAN FAILURE 91
RENAL INJURY 91
FEAR 86
CARDIAC ARREST 85
EMOTIONAL DISTRESS 84
RENAL IMPAIRMENT 82
ANHEDONIA 77
HYPOTENSION 74
STRESS 71
SEPSIS 70
RESPIRATORY FAILURE 69
PNEUMONIA 64
PYREXIA 58

Reactions in Hospitalization Reports

Top reactions in 4,522 reports where hospitalization was an outcome.

Reaction Reports
RASH 282
PYREXIA 253
HYPOTENSION 244
RENAL FAILURE 214
PAIN 207
ACUTE KIDNEY INJURY 206
ANAPHYLACTIC REACTION 194
DRUG INTERACTION 174
NAUSEA 162
DYSPNOEA 154
ANXIETY 153
DRUG HYPERSENSITIVITY 147
VOMITING 142
DIARRHOEA 140
INFECTION 138
CELLULITIS 135
URTICARIA 130
PNEUMONIA 129

Compare cefazolin vs amikacin →

What the FAERS Data Reveals About cefazolin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 8,788 voluntary reports linked to cefazolin and its brand equivalents (Ancef, Kefzol), spanning 2004 through 2025. Of those, 1,005 (11.4%) listed death as an outcome and 4,522 (51.5%) 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, 49% were female and 51% male; age distribution skews toward 45-64, with 2,325 reports in that bracket. The single most reported reaction is hypotension with 542 submissions, followed by anaphylactic reaction and rash.

How to read these numbers

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.