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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.

CLAVULANIC ACID: 661 Adverse Event Reports & Safety Profile

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661
Total FAERS Reports
82 (12.4%)
Deaths Reported
372
Hospitalizations
661
As Primary/Secondary Suspect
82
Life-Threatening
2
Disabilities

First Report: 19950117 · Latest Report: 20250728

What Are the Most Common CLAVULANIC ACID Side Effects?

#1 Most Reported
Cholestasis
48 reports (7.3%)
#2 Most Reported
Hepatic cytolysis
40 reports (6.1%)
#3 Most Reported
Hepatocellular injury
38 reports (5.7%)

All CLAVULANIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cholestasis 48 7.3% 7 21
Hepatic cytolysis 40 6.1% 0 21
Hepatocellular injury 38 5.8% 0 21
Acute kidney injury 34 5.1% 5 11
Anaphylactic shock 31 4.7% 1 9
Mixed liver injury 30 4.5% 0 28
Drug hypersensitivity 29 4.4% 0 1
Acute generalised exanthematous pustulosis 28 4.2% 0 19
Condition aggravated 28 4.2% 2 27
Toxic skin eruption 27 4.1% 0 13
Rash 26 3.9% 2 11
Diarrhoea 23 3.5% 7 11
Drug reaction with eosinophilia and systemic symptoms 21 3.2% 2 19
Clostridium difficile colitis 17 2.6% 0 14
Hepatitis cholestatic 17 2.6% 9 11
Pruritus 17 2.6% 2 4
Thrombocytopenia 17 2.6% 0 2
Anaemia 16 2.4% 1 3
Drug ineffective 16 2.4% 4 10
Jaundice 16 2.4% 0 12

Who Reports CLAVULANIC ACID Side Effects? Age & Gender Data

Gender: 48.7% female, 51.3% male. Average age: 61.9 years. Most reports from: FR. View detailed demographics →

Is CLAVULANIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 9 8 9
2010 1 0 1
2011 2 0 0
2012 1 0 0
2013 5 0 5
2014 11 3 5
2015 2 0 1
2016 15 3 10
2017 15 1 8
2018 76 13 49
2019 52 0 37
2020 83 3 39
2021 60 14 32
2022 45 0 32
2023 81 17 44
2024 67 0 40
2025 21 0 13

View full timeline →

What Is CLAVULANIC ACID Used For?

IndicationReports
Product used for unknown indication 92
Infection 66
Lung disorder 43
Pneumonia 32
Antibiotic prophylaxis 27
Antibiotic therapy 26
Urinary tract infection 26
Bronchitis 25
Pneumonia aspiration 21
Bacteraemia 20

CLAVULANIC ACID vs Alternatives: Which Is Safer?

CLAVULANIC ACID vs CLEMASTINE CLAVULANIC ACID vs CLENBUTEROL CLAVULANIC ACID vs CLEVIDIPINE CLAVULANIC ACID vs CLEXANE CLAVULANIC ACID vs CLINDAMYCIN CLAVULANIC ACID vs CLINDAMYCIN\CLINDAMYCIN CLAVULANIC ACID vs CLINDAMYCIN\TRETINOIN CLAVULANIC ACID vs CLIOQUINOL CLAVULANIC ACID vs CLIOQUINOL\FLUMETHASONE CLAVULANIC ACID vs CLOBAZAM

Official FDA Label for CLAVULANIC ACID

Official prescribing information from the FDA-approved drug label.