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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

FLUCLOXACILLIN: 1,496 Adverse Event Reports & Safety Profile

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1,496
Total FAERS Reports
187 (12.5%)
Deaths Reported
797
Hospitalizations
1,496
As Primary/Secondary Suspect
254
Life-Threatening
43
Disabilities

First Report: 1989 · Latest Report: 20250515

What Are the Most Common FLUCLOXACILLIN Side Effects?

#1 Most Reported
Metabolic acidosis
211 reports (14.1%)
#2 Most Reported
Drug ineffective
136 reports (9.1%)
#3 Most Reported
Drug interaction
134 reports (9.0%)

All FLUCLOXACILLIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Metabolic acidosis 211 14.1% 35 119
Drug ineffective 136 9.1% 33 79
Drug interaction 134 9.0% 22 56
Acute kidney injury 112 7.5% 22 76
Pyroglutamic acidosis 83 5.6% 11 59
Pyrexia 71 4.8% 8 54
Nausea 61 4.1% 1 40
Diarrhoea 58 3.9% 8 37
Drug reaction with eosinophilia and systemic symptoms 57 3.8% 8 25
Off label use 56 3.7% 26 27
Rash 51 3.4% 4 21
Vomiting 51 3.4% 1 44
Renal failure 50 3.3% 23 26
Jaundice 49 3.3% 0 39
Liver function test abnormal 48 3.2% 4 41
Clostridium difficile infection 47 3.1% 0 24
Tubulointerstitial nephritis 47 3.1% 0 26
Condition aggravated 46 3.1% 11 23
Malaise 45 3.0% 1 35
Confusional state 43 2.9% 9 30

Who Reports FLUCLOXACILLIN Side Effects? Age & Gender Data

Gender: 54.1% female, 45.9% male. Average age: 57.0 years. Most reports from: GB. View detailed demographics →

Is FLUCLOXACILLIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 6 6 0
2001 1 0 1
2007 1 0 1
2008 3 0 1
2009 6 1 3
2010 4 1 4
2011 34 0 31
2012 7 5 6
2013 17 1 15
2014 57 14 35
2015 32 1 16
2016 56 0 30
2017 36 4 25
2018 81 1 46
2019 54 7 32
2020 68 14 42
2021 61 8 26
2022 26 5 11
2023 32 3 11
2024 37 2 12
2025 15 3 9

View full timeline →

What Is FLUCLOXACILLIN Used For?

IndicationReports
Product used for unknown indication 346
Cellulitis 123
Staphylococcal infection 98
Staphylococcal bacteraemia 79
Wound infection 40
Antibiotic therapy 38
Infection 36
Device related infection 25
Arthritis bacterial 23
Osteomyelitis 22

FLUCLOXACILLIN vs Alternatives: Which Is Safer?

FLUCLOXACILLIN vs FLUCONAZOLE FLUCLOXACILLIN vs FLUCYTOSINE FLUCLOXACILLIN vs FLUDARABINE FLUCLOXACILLIN vs FLUDEOXYGLUCOSE F-18 FLUCLOXACILLIN vs FLUDROCORTISONE FLUCLOXACILLIN vs FLUINDIONE FLUCLOXACILLIN vs FLUMAZENIL FLUCLOXACILLIN vs FLUMETHASONE FLUCLOXACILLIN vs FLUMETHASONE PIVALATE FLUCLOXACILLIN vs FLUMETHASONE\SALICYLIC ACID

Official FDA Label for FLUCLOXACILLIN

Official prescribing information from the FDA-approved drug label.