CLOXACILLIN: 994 Adverse Event Reports & Safety Profile
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994
Total FAERS Reports
106 (10.7%)
Deaths Reported
618
Hospitalizations
994
As Primary/Secondary Suspect
90
Life-Threatening
8
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 050192 ·
First Report: 19841026 · Latest Report: 20250822
What Are the Most Common CLOXACILLIN Side Effects?
#1 Most Reported
Acute kidney injury
180 reports (18.1%)
#2 Most Reported
Drug reaction with eosinophilia and systemic symptoms
121 reports (12.2%)
#3 Most Reported
Drug ineffective
65 reports (6.5%)
All CLOXACILLIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Acute kidney injury | 180 | 18.1% | 29 | 124 |
| Drug reaction with eosinophilia and systemic symptoms | 121 | 12.2% | 2 | 89 |
| Drug ineffective | 65 | 6.5% | 18 | 32 |
| Thrombocytopenia | 63 | 6.3% | 3 | 44 |
| Agranulocytosis | 53 | 5.3% | 0 | 41 |
| Rash maculo-papular | 51 | 5.1% | 0 | 28 |
| Rash | 49 | 4.9% | 9 | 25 |
| Pyrexia | 47 | 4.7% | 0 | 38 |
| Eosinophilia | 41 | 4.1% | 1 | 26 |
| Condition aggravated | 39 | 3.9% | 0 | 27 |
| Neutropenia | 38 | 3.8% | 1 | 27 |
| Tubulointerstitial nephritis | 38 | 3.8% | 0 | 37 |
| Drug hypersensitivity | 35 | 3.5% | 0 | 7 |
| Cholestasis | 34 | 3.4% | 3 | 25 |
| Off label use | 33 | 3.3% | 3 | 11 |
| Toxic epidermal necrolysis | 33 | 3.3% | 1 | 29 |
| Jaundice | 27 | 2.7% | 2 | 21 |
| Leukopenia | 26 | 2.6% | 0 | 21 |
| Pancytopenia | 24 | 2.4% | 5 | 18 |
| Product use in unapproved indication | 24 | 2.4% | 0 | 11 |
Who Reports CLOXACILLIN Side Effects? Age & Gender Data
Gender: 37.9% female, 62.1% male. Average age: 60.0 years. Most reports from: FR. View detailed demographics →
Is CLOXACILLIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2010 | 3 | 0 | 3 |
| 2011 | 2 | 0 | 0 |
| 2012 | 10 | 3 | 9 |
| 2013 | 10 | 1 | 6 |
| 2014 | 33 | 3 | 22 |
| 2015 | 37 | 2 | 27 |
| 2016 | 46 | 8 | 40 |
| 2017 | 48 | 11 | 34 |
| 2018 | 85 | 13 | 48 |
| 2019 | 105 | 5 | 77 |
| 2020 | 100 | 19 | 69 |
| 2021 | 59 | 0 | 39 |
| 2022 | 91 | 11 | 56 |
| 2023 | 37 | 1 | 22 |
| 2024 | 22 | 1 | 3 |
| 2025 | 13 | 0 | 12 |
What Is CLOXACILLIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 149 |
| Infection | 105 |
| Staphylococcal infection | 85 |
| Endocarditis | 68 |
| Staphylococcal bacteraemia | 51 |
| Arthritis bacterial | 33 |
| Sepsis | 33 |
| Bacteraemia | 31 |
| Device related infection | 28 |
| Antibiotic therapy | 25 |
CLOXACILLIN vs Alternatives: Which Is Safer?
CLOXACILLIN vs CLOXAZOLAM
CLOXACILLIN vs CLOZAPINE
CLOXACILLIN vs CLOZARIL
CLOXACILLIN vs COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN
CLOXACILLIN vs COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN
CLOXACILLIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN
CLOXACILLIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL
CLOXACILLIN vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN
CLOXACILLIN vs COBAMAMIDE
CLOXACILLIN vs COBICISTAT
Official FDA Label for CLOXACILLIN
Official prescribing information from the FDA-approved drug label.