Augmentin: adverse event reports filed with FDA

9,436

reports as suspect product

0.1% of all reports · about 419 a year

412

reports, 12 months to June 2026

526 in the 12 months before

72.2%

marked serious by the reporter

81% across the class

6.4%

record death among outcomes, as reported

603 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Augmentin reports recording the termmedian drug in penicillin-class antibacterial

1. Drug hypersensitivityan allergic-type reaction to a medicine16.2%1,529
2. Diarrhoealoose or frequent stools7.8%736
3. Rashskin rash4.9%460
4. Cholestasis4.6%431
5. Vomitingbeing sick4.4%412
6. Nauseafeeling sick4.2%393
7. Pruritusitching4.1%387
8. Pyrexiafever3.7%346
9. Rash maculo-papulara rash of flat and raised spots3.4%317
10. Acute kidney injurysudden loss of kidney function3.2%298
11. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement3%287
12. Dyspnoeashortness of breath2.9%275
13. Urticariahives2.9%272
14. Erythemaskin redness2.8%260
15. Hepatocellular injury2.7%256
16. Drug ineffectivethe medicine did not work as expected2.6%250
17. Drug interactionan interaction between medicines2.6%250
18. Hypersensitivityan allergic-type reaction2.6%250
19. Thrombocytopenialow platelets2.2%204
20. Jaundiceyellowing of the skin or eyes2.1%195
21. Fatiguetiredness2%192
22. Hepatic cytolysis2%185
23. Hypotensionlow blood pressure1.9%183
24. Condition aggravatedthe condition being treated got worse1.9%180
25. Malaisegeneral feeling of being unwell1.9%180
26. Astheniaweakness or lack of energy1.9%176
27. Toxic skin eruption1.8%174
28. Off label useused for a purpose or in a way not on the label1.8%168
29. Eosinophilia1.8%167
30. Dizzinesslight-headedness or unsteadiness1.8%166

Top 30 of 1,141 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 15 drugs in the penicillin-class antibacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 64,409 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,436 reports.

Drugs most often listed in the same reports

Other products listed in reports where Augmentin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the penicillin-class antibacterial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Augmentin as a suspect or interacting product; reports listing it only as a concomitant medication (13,688) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.