Mupirocin side effects: what 13,399 FDA adverse event reports show
Drug class
RNA Synthetase Inhibitor Antibacterial
Who reports
13,399 reports · 57% serious · 922 with death outcome · 63% female
Used for
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin Ointment USP, 2% is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes.
What it is
Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin.
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.
- 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. 1,082 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 163 | 1,808.5 1,443.2–2,266.3ROR 1,830.7 · χ² 134,698 / p <1e-300 | 758.2 EB05 665.4 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 100% (drug 63%) | not reported in cached trials |
| Nasal vestibulitis | 17 | 315.9 187.5–532.1ROR 316.3 · χ² 4,171 / p <1e-300 | 202.8 EB05 134.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Purpura senile | 13 | 190.9 107.3–339.7ROR 191.1 · χ² 2,020 / p <1e-300 | 136.4 EB05 84.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Burkholderia test positive | 13 | 182.3 102.6–323.8ROR 182.4 · χ² 1,937 / p <1e-300 | 132.0 EB05 82.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Female genital tract fistula | 172 | 173.7 148.5–203.2ROR 176.0 · χ² 26,392 / p <1e-300 | 153.6 EB05 135.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=172 · ♀ 100% (drug 63%) | not reported in cached trials |
| Radiculopathy | 174 | 110.5 94.8–128.7ROR 111.9 · χ² 17,514 / p <1e-300 | 102.0 EB05 89.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=174 · ♀ 100% (drug 63%) | not reported in cached trials |
| Macular degeneration | 759 | 106.4 99.0–114.3ROR 112.7 · χ² 74,070 / p <1e-300 | 99.3 EB05 93.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 108.7 · ♀ 100% (drug 63%) | not reported in cached trials |
| Chronic sinusitis | 226 | 100.4 87.8–114.7ROR 102.1 · χ² 20,789 / p <1e-300 | 93.6 EB05 83.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=220 · ♀ 100% (drug 63%) | not reported in cached trials |
| Proctitis | 164 | 97.1 83.0–113.6ROR 98.3 · χ² 14,590 / p <1e-300 | 90.5 EB05 79.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 100% (drug 63%) | not reported in cached trials |
| Maternal condition affecting foetus | 12 | 89.0 49.7–159.2ROR 89.1 · χ² 905 / p 3e-199 | 74.6 EB05 45.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Tarsal tunnel syndrome | 11 | 82.0 44.7–150.3ROR 82.0 · χ² 760 / p 1e-167 | 69.0 EB05 41.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 48 | 73.0 54.7–97.5ROR 73.3 · χ² 3,186 / p <1e-300 | 67.9 EB05 53.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Humidity intolerance | 17 | 70.1 43.1–113.9ROR 70.2 · χ² 1,042 / p 5e-229 | 62.6 EB05 41.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Teratogenicity | 12 | 64.5 36.2–114.9ROR 64.5 · χ² 660 / p 7e-146 | 56.7 EB05 34.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Intercepted product prescribing error | 39 | 48.5 35.3–66.7ROR 48.6 · χ² 1,713 / p <1e-300 | 46.1 EB05 35.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Hyperparathyroidism secondary | 72 | 45.8 36.2–57.8ROR 46.0 · χ² 3,018 / p <1e-300 | 44.0 EB05 36.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=72 | not reported in cached trials |
| Nephrogenic anaemia | 122 | 41.9 35.0–50.1ROR 42.3 · χ² 4,701 / p <1e-300 | 40.6 EB05 34.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=122 | not reported in cached trials |
| Rebound acid hypersecretion | 57 | 29.6 22.8–38.4ROR 29.7 · χ² 1,518 / p <1e-300 | 28.8 EB05 23.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=57 | not reported in cached trials |
| Seborrhoeic keratosis | 27 | 29.3 20.0–42.9ROR 29.4 · χ² 697 / p 6e-154 | 28.3 EB05 20.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Folate deficiency | 20 | 27.8 17.8–43.2ROR 27.8 · χ² 481 / p 7e-107 | 26.7 EB05 18.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Vaginal discharge | 165 | 26.1 22.4–30.4ROR 26.4 · χ² 3,894 / p <1e-300 | 25.6 EB05 22.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 100% (drug 63%) | not reported in cached trials |
| Nasal discharge discolouration | 22 | 25.3 16.6–38.5ROR 25.3 · χ² 481 / p 6e-107 | 24.4 EB05 17.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Paraesthesia oral | 226 | 25.0 21.9–28.4ROR 25.4 · χ² 5,097 / p <1e-300 | 24.5 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.8 · ♀ 100% (drug 63%) | not reported in cached trials |
| Cleft lip and palate | 17 | 23.9 14.8–38.6ROR 23.9 · χ² 345 / p 2e-77 | 23.0 EB05 15.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Resorption bone increased | 12 | 23.2 13.1–41.1ROR 23.2 · χ² 230 / p 3e-52 | 22.0 EB05 13.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Impetigo | 21 | 22.5 14.6–34.5ROR 22.5 · χ² 404 / p 5e-90 | 21.7 EB05 14.9 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=13 | not reported in cached trials |
| Oral candidiasis (oral thrush) | 184 | 22.4 19.4–25.9ROR 22.7 · χ² 3,693 / p <1e-300 | 22.1 EB05 19.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.0 · ♀ 96% (drug 63%) | not reported in cached trials |
| Bone demineralisation | 15 | 22.4 13.5–37.3ROR 22.4 · χ² 281 / p 2e-63 | 21.5 EB05 13.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Body temperature abnormal | 24 | 20.6 13.8–30.8ROR 20.6 · χ² 423 / p 3e-94 | 20.0 EB05 14.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=24 | not reported in cached trials |
| Skin weeping | 41 | 19.5 14.3–26.5ROR 19.6 · χ² 693 / p 6e-153 | 19.1 EB05 14.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Cutaneous t-cell lymphoma | 14 | 18.6 11.0–31.6ROR 18.7 · χ² 214 / p 1e-48 | 17.7 EB05 10.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Infusion site discharge | 19 | 17.6 11.2–27.6ROR 17.6 · χ² 277 / p 2e-62 | 16.9 EB05 11.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Infusion site bruising | 22 | 16.3 10.7–24.9ROR 16.4 · χ² 298 / p 4e-67 | 15.8 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Infusion site mass | 11 | 16.3 9.0–29.5ROR 16.3 · χ² 141 / p 7e-33 | 14.8 EB05 7.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Groin abscess | 12 | 16.2 9.2–28.7ROR 16.3 · χ² 155 / p 6e-36 | 15.0 EB05 8.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| End stage renal disease | 185 | 15.9 13.7–18.3ROR 16.1 · χ² 2,536 / p <1e-300 | 15.7 EB05 13.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 | not reported in cached trials |
| Aspergillosis | 13 | 15.5 9.0–26.7ROR 15.5 · χ² 160 / p 5e-37 | 14.3 EB05 8.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Staphylococcal skin infection | 12 | 15.3 8.7–27.0ROR 15.3 · χ² 145 / p 1e-33 | 13.9 EB05 7.6 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | not reported in cached trials |
| Vestibular disorder | 11 | 14.1 7.8–25.6ROR 14.2 · χ² 120 / p 2e-28 | 12.4 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Perirectal abscess | 10 | 14.1 7.6–26.3ROR 14.1 · χ² 108 / p 1e-25 | 12.2 EB05 6.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | 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 Mupirocin 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).
- NCT03140423 — Mupirocin-Iodophor ICU Decolonization Swap Out Trial (N=353323, PHASE4; 1 AE terms posted; arms: Arm 1: Routine Care (Mupirocin/CHG); Arm 2: Iodophor/CHG Decolonization)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,490 | 1.8 1.7–1.9ROR 1.9 · χ² 532 / p 6e-118 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.5 | not reported in cached trials |
| Off label use (used outside approved label) | 967 | 1.7 1.6–1.9ROR 1.8 · χ² 319 / p 1e-71 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Nausea | 932 | 1.8 1.7–2.0ROR 1.9 · χ² 376 / p 5e-84 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.7 | not reported in cached trials |
| Pain | 914 | 2.3 2.2–2.5ROR 2.4 · χ² 709 / p 2e-156 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | not reported in cached trials |
| Product use in unapproved indication | 841 | 5.4 5.1–5.8ROR 5.7 · χ² 3,035 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Fatigue (tiredness) | 805 | 1.6 1.5–1.7ROR 1.7 · χ² 198 / p 3e-45 | 1.6 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Macular degeneration | 759 | 106.4 99.0–114.3ROR 112.7 · χ² 74,070 / p <1e-300 | 99.3 EB05 93.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 108.7 · ♀ 100% (drug 63%) | not reported in cached trials |
| Headache | 750 | 1.9 1.7–2.0ROR 1.9 · χ² 314 / p 1e-70 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.8 · ♀ 85% (drug 63%) | not reported in cached trials |
| Diarrhoea (diarrhea) | 694 | 1.7 1.6–1.8ROR 1.7 · χ² 200 / p 1e-45 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Rash | 605 | 2.2 2.0–2.4ROR 2.2 · χ² 395 / p 4e-88 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Chronic kidney disease | 580 | 11.9 11.0–12.9ROR 12.4 · χ² 5,766 / p <1e-300 | 11.8 EB05 11.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | not reported in cached trials |
| Pruritus (itching) | 576 | 2.4 2.2–2.6ROR 2.4 · χ² 470 / p 2e-104 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | not reported in cached trials |
| Weight decreased (weight loss) | 567 | 3.2 2.9–3.4ROR 3.3 · χ² 856 / p 2e-188 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | not reported in cached trials |
| Pyrexia (fever) | 535 | 2.4 2.2–2.6ROR 2.5 · χ² 451 / p 3e-100 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 525 | 1.5 1.3–1.6ROR 1.5 · χ² 75 / p 2e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | 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.
- Vaginal flatulence — n=163, PRR 1,808.5
- Female genital tract fistula — n=172, PRR 173.7
- Radiculopathy — n=174, PRR 110.5
- Macular degeneration — n=759, PRR 106.4
- Chronic sinusitis — n=226, PRR 100.4
- Proctitis — n=164, PRR 97.1
- Chronic kidney disease-mineral and bone disorder — n=48, PRR 73.0
- Intercepted product prescribing error — n=39, PRR 48.5
- Hyperparathyroidism secondary — n=72, PRR 45.8
- Nephrogenic anaemia — n=122, PRR 41.9
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 Mupirocin?
In FDA FAERS, the most frequently co-reported reaction terms for Mupirocin are nausea, pain, fatigue, macular degeneration, headache, diarrhoea. 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 Mupirocin have an FDA boxed warning?
No. The FDA label retrieved for Mupirocin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Mupirocin 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 1cd4c71f-138b-47c2-8ce8-9ac32408dc56, effective 20230718; matched on
openfda.generic_name.exact:"MUPIROCIN") - 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, 1,122 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
MUPIROCIN, 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.