AUGMENTIN: 224 Adverse Event Reports & Safety Profile
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224
Total FAERS Reports
19 (8.5%)
Deaths Reported
111
Hospitalizations
224
As Primary/Secondary Suspect
21
Life-Threatening
3
Disabilities
First Report: 19960602 · Latest Report: 20140619
What Are the Most Common AUGMENTIN Side Effects?
#1 Most Reported
Drug hypersensitivity
54 reports (24.1%)
#2 Most Reported
Rash
18 reports (8.0%)
#3 Most Reported
Diarrhoea
15 reports (6.7%)
All AUGMENTIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 54 | 24.1% | 1 | 4 |
| Rash | 18 | 8.0% | 0 | 12 |
| Diarrhoea | 15 | 6.7% | 0 | 9 |
| Drug reaction with eosinophilia and systemic symptoms | 13 | 5.8% | 5 | 9 |
| Pruritus | 11 | 4.9% | 0 | 8 |
| Renal failure acute | 11 | 4.9% | 1 | 11 |
| Vomiting | 10 | 4.5% | 0 | 5 |
| Jaundice | 9 | 4.0% | 0 | 8 |
| Malaise | 9 | 4.0% | 0 | 8 |
| Cholestasis | 8 | 3.6% | 0 | 6 |
| Drug-induced liver injury | 8 | 3.6% | 0 | 5 |
| Eosinophilia | 8 | 3.6% | 0 | 8 |
| Nausea | 8 | 3.6% | 0 | 3 |
| Pain in extremity | 8 | 3.6% | 0 | 6 |
| Pallor | 8 | 3.6% | 0 | 7 |
| Pyrexia | 8 | 3.6% | 0 | 8 |
| Rash maculo-papular | 8 | 3.6% | 0 | 7 |
| Urticaria | 8 | 3.6% | 0 | 1 |
| Hepatitis | 7 | 3.1% | 4 | 7 |
| Abdominal pain | 5 | 2.2% | 0 | 3 |
Who Reports AUGMENTIN Side Effects? Age & Gender Data
Average age: 58.8 years. Most reports from: US. View detailed demographics →
Is AUGMENTIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 1 |
| 2007 | 2 | 0 | 2 |
| 2008 | 3 | 1 | 2 |
| 2009 | 3 | 1 | 1 |
| 2010 | 3 | 0 | 2 |
| 2011 | 3 | 0 | 2 |
| 2012 | 10 | 0 | 8 |
| 2013 | 64 | 10 | 46 |
| 2014 | 64 | 2 | 39 |
What Is AUGMENTIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 28 |
| Pneumonia | 9 |
| Pyrexia | 8 |
| Infection | 7 |
| Lung disorder | 7 |
| Sinusitis | 6 |
| Bronchitis | 5 |
| Multiple injuries | 5 |
AUGMENTIN vs Alternatives: Which Is Safer?
AUGMENTIN vs AUTOLOGOUS CULTURED CHONDROCYTES
AUGMENTIN vs AUTOLOGOUS CULTURED CHONDROCYTES\SUS SCROFA COLLAGEN
AUGMENTIN vs AVACINCAPTAD PEGOL
AUGMENTIN vs AVACOPAN
AUGMENTIN vs AVALGLUCOSIDASE ALFA-NGPT
AUGMENTIN vs AVANAFIL
AUGMENTIN vs AVANDAMET
AUGMENTIN vs AVANDIA
AUGMENTIN vs AVAPRITINIB
AUGMENTIN vs AVASTIN
Official FDA Label for AUGMENTIN
Official prescribing information from the FDA-approved drug label.