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mupirocin Side Effects

Also known as: Bactroban

Analysis of 12,758 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

12,758

Death-Related

895

7.0% of reports

Hospitalizations

3,409

26.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,434
OFF LABEL USE
920
NAUSEA
882
PAIN
877
PRODUCT USE IN UNAPPROVED INDICATION
818
FATIGUE
765
MACULAR DEGENERATION
750
HEADACHE
712
DIARRHOEA
648
CHRONIC KIDNEY DISEASE
578
RASH
562
WEIGHT DECREASED
549
PYREXIA
526
PRURITUS
521
MALAISE
500
DYSPNOEA
497
RENAL FAILURE
453
PNEUMONIA
435
ACUTE KIDNEY INJURY
425
DEATH
423

Who Reports Side Effects

Gender Distribution

Female 6,686 (63%)
Male 3,993 (37%)
Unknown 6

Age Distribution

0-17 645 (10%)
18-44 1,019 (15%)
45-64 2,328 (34%)
65-74 1,634 (24%)
75+ 1,142 (17%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 895 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 419
PNEUMONIA 82
RENAL FAILURE 79
ACUTE KIDNEY INJURY 73
CHRONIC KIDNEY DISEASE 73
OFF LABEL USE 65
DYSPNOEA 63
NAUSEA 63
DIARRHOEA 58
FATIGUE 58
ASTHENIA 55
DECREASED APPETITE 55
RESPIRATORY FAILURE 52
WEIGHT DECREASED 52
SEPSIS 46
END STAGE RENAL DISEASE 45
HYPOTENSION 42
FALL 39
PYREXIA 39
THROMBOCYTOPENIA 39

Reactions in Hospitalization Reports

Top reactions in 3,409 reports where hospitalization was an outcome.

Reaction Reports
NAUSEA 457
PAIN 437
PYREXIA 397
WEIGHT DECREASED 376
OFF LABEL USE 370
PNEUMONIA 342
HEADACHE 340
MALAISE 331
DRUG INEFFECTIVE 317
ABDOMINAL PAIN 280
DYSPNOEA 280
ANAEMIA 275
FATIGUE 256
DIARRHOEA 247
CONSTIPATION 235
MACULAR DEGENERATION 235
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 220
ERYTHEMA 218
FALL 218
DYSPEPSIA 213

Nearby — Related Medications

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What the FAERS Data Reveals About mupirocin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 12,758 voluntary reports linked to mupirocin and its brand equivalents (Bactroban), spanning 2004 through 2025. Of those, 895 (7.0%) listed death as an outcome and 3,409 (26.7%) 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, 63% were female and 37% male; age distribution skews toward 45-64, with 2,328 reports in that bracket. The single most reported reaction is drug ineffective with 1,434 submissions, followed by off label use and nausea.

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.