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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.

AMOXICILLIN\CLAVULANIC ACID: 10,588 Adverse Event Reports & Safety Profile

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10,588
Total FAERS Reports
885 (8.4%)
Deaths Reported
5,097
Hospitalizations
10,588
As Primary/Secondary Suspect
1,049
Life-Threatening
222
Disabilities

First Report: 19420123 · Latest Report: 20250926

What Are the Most Common AMOXICILLIN\CLAVULANIC ACID Side Effects?

#1 Most Reported
Drug ineffective
985 reports (9.3%)
#2 Most Reported
Diarrhoea
657 reports (6.2%)
#3 Most Reported
Pyrexia
623 reports (5.9%)

All AMOXICILLIN\CLAVULANIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 985 9.3% 171 585
Diarrhoea 657 6.2% 69 363
Drug-induced liver injury 623 5.9% 33 229
Pyrexia 623 5.9% 79 445
Dyspnoea 609 5.8% 79 378
Pruritus 565 5.3% 6 266
Rash 497 4.7% 18 225
Off label use 460 4.3% 74 276
Vomiting 434 4.1% 31 225
Condition aggravated 414 3.9% 77 315
Drug reaction with eosinophilia and systemic symptoms 376 3.6% 8 275
Erythema 373 3.5% 10 164
Anaphylactic reaction 354 3.3% 22 145
Nausea 343 3.2% 18 134
Urticaria 343 3.2% 4 136
Acute kidney injury 340 3.2% 52 258
Malaise 334 3.2% 34 143
Rash maculo-papular 320 3.0% 4 140
Drug hypersensitivity 270 2.6% 6 111
Abdominal pain 237 2.2% 5 148

Who Reports AMOXICILLIN\CLAVULANIC ACID Side Effects? Age & Gender Data

Gender: 52.8% female, 47.2% male. Average age: 51.1 years. Most reports from: GB. View detailed demographics →

Is AMOXICILLIN\CLAVULANIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 0 1
2002 8 6 0
2003 1 0 1
2004 9 1 4
2005 4 0 4
2006 4 1 1
2007 9 1 4
2008 11 9 5
2009 29 5 19
2010 34 3 20
2011 20 1 12
2012 57 10 46
2013 46 8 29
2014 299 9 174
2015 446 41 237
2016 488 45 236
2017 607 48 287
2018 701 69 347
2019 489 39 232
2020 441 30 185
2021 305 29 125
2022 437 16 213
2023 417 23 169
2024 304 17 152
2025 161 5 74

View full timeline →

What Is AMOXICILLIN\CLAVULANIC ACID Used For?

IndicationReports
Product used for unknown indication 2,588
Pneumonia 561
Antibiotic therapy 402
Urinary tract infection 305
Respiratory tract infection 299
Tuberculosis 264
Infection 244
Antibiotic prophylaxis 222
Sinusitis 217
Pyrexia 193

AMOXICILLIN\CLAVULANIC ACID vs Alternatives: Which Is Safer?

AMOXICILLIN\CLAVULANIC ACID vs AMOXICILLIN\OMEPRAZOLE\RIFABUTIN AMOXICILLIN\CLAVULANIC ACID vs AMPHETAMINE AMOXICILLIN\CLAVULANIC ACID vs AMPHETAMINE ASPARTATE\AMPHETAMINE ASPARTATE\AMPHETAMINE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE AMOXICILLIN\CLAVULANIC ACID vs AMPHETAMINE ASPARTATE\AMPHETAMINE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE AMOXICILLIN\CLAVULANIC ACID vs AMPHETAMINE\DEXTROAMPHETAMINE AMOXICILLIN\CLAVULANIC ACID vs AMPHOTERICIN B AMOXICILLIN\CLAVULANIC ACID vs AMPHOTERICIN B\DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-\DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- AMOXICILLIN\CLAVULANIC ACID vs AMPICILLIN AMOXICILLIN\CLAVULANIC ACID vs AMPICILLIN\SULBACTAM AMOXICILLIN\CLAVULANIC ACID vs AMPRENAVIR

Official FDA Label for AMOXICILLIN\CLAVULANIC ACID

Official prescribing information from the FDA-approved drug label.