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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\CLAVULANATE: 15,434 Adverse Event Reports & Safety Profile

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15,434
Total FAERS Reports
998 (6.5%)
Deaths Reported
6,376
Hospitalizations
15,434
As Primary/Secondary Suspect
1,275
Life-Threatening
299
Disabilities

Active Ingredient: AMOXICILLIN\CLAVULANATE POTASSIUM ·

First Report: 19420123 · Latest Report: 20250914

What Are the Most Common AMOXICILLIN\CLAVULANATE Side Effects?

#1 Most Reported
Drug hypersensitivity
1,746 reports (11.3%)
#2 Most Reported
Diarrhoea
1,301 reports (8.4%)
#3 Most Reported
Vomiting
812 reports (5.3%)

All AMOXICILLIN\CLAVULANATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 1,746 11.3% 8 162
Diarrhoea 1,301 8.4% 75 483
Vomiting 812 5.3% 70 318
Nausea 766 5.0% 36 266
Rash 760 4.9% 35 284
Drug-induced liver injury 751 4.9% 32 191
Dyspnoea 750 4.9% 102 427
Drug ineffective 712 4.6% 88 267
Pruritus 645 4.2% 26 287
Pyrexia 597 3.9% 77 396
Condition aggravated 552 3.6% 80 387
Urticaria 491 3.2% 6 158
Cholestasis 480 3.1% 21 341
Acute kidney injury 459 3.0% 66 364
Hypersensitivity 434 2.8% 1 123
Drug reaction with eosinophilia and systemic symptoms 429 2.8% 18 307
Fatigue 403 2.6% 19 190
Erythema 402 2.6% 14 182
Malaise 388 2.5% 51 187
Asthma 364 2.4% 28 262

Who Reports AMOXICILLIN\CLAVULANATE Side Effects? Age & Gender Data

Gender: 55.9% female, 44.1% male. Average age: 55.7 years. Most reports from: US. View detailed demographics →

Is AMOXICILLIN\CLAVULANATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 9 1 2
2001 16 0 15
2002 17 12 2
2003 18 1 16
2004 10 1 7
2005 7 1 3
2006 5 0 2
2007 36 18 27
2008 23 4 14
2009 30 0 16
2010 50 2 25
2011 58 3 33
2012 72 4 49
2013 106 7 55
2014 442 24 249
2015 579 32 291
2016 534 52 285
2017 950 76 510
2018 1,194 99 653
2019 1,031 101 507
2020 798 47 372
2021 622 62 323
2022 635 23 319
2023 749 34 371
2024 712 29 371
2025 313 12 136

View full timeline →

What Is AMOXICILLIN\CLAVULANATE Used For?

IndicationReports
Product used for unknown indication 4,774
Infection 705
Sinusitis 607
Pneumonia 532
Lung disorder 393
Antibiotic prophylaxis 370
Bronchitis 351
Antibiotic therapy 324
Urinary tract infection 324
Pyrexia 217

AMOXICILLIN\CLAVULANATE vs Alternatives: Which Is Safer?

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

Official FDA Label for AMOXICILLIN\CLAVULANATE

Official prescribing information from the FDA-approved drug label.