Amoxicillin: adverse event reports filed with FDA

31,984

reports as suspect product

0.2% of all reports · about 1,422 a year

2,311

reports, 12 months to June 2026

2,377 in the 12 months before

83.8%

marked serious by the reporter

81% across the class

4.5%

record death among outcomes, as reported

1,438 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 Amoxicillin reports recording the termmedian drug in penicillin-class antibacterial

1. Drug hypersensitivityan allergic-type reaction to a medicine10.9%3,475
2. Rashskin rash7.6%2,423
3. Pruritusitching6.1%1,944
4. Diarrhoealoose or frequent stools5.4%1,727
5. Urticariahives5.4%1,720
6. Drug ineffectivethe medicine did not work as expected5%1,588
7. Dyspnoeashortness of breath4.8%1,532
8. Nauseafeeling sick4.4%1,395
9. Erythemaskin redness4.1%1,305
10. Hypersensitivityan allergic-type reaction4%1,271
11. Pyrexiafever4%1,269
12. Vomitingbeing sick4%1,265
13. Malaisegeneral feeling of being unwell3.6%1,162
14. Acute kidney injurysudden loss of kidney function3.6%1,154
15. Off label useused for a purpose or in a way not on the label3.6%1,152
16. Headachehead pain3.1%1,000
17. Painpain, site not specified2.8%906
18. Anaphylactic reactiona severe, sudden allergic reaction2.8%892
19. Angioedemadeep swelling of skin or mucous membranes2.7%873
20. Abdominal painstomach or belly pain2.7%872
21. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.7%871
22. Rash maculo-papulara rash of flat and raised spots2.6%831
23. Drug interactionan interaction between medicines2.5%793
24. Anaphylactic shocka severe allergic reaction with collapse2.3%747
25. Dizzinesslight-headedness or unsteadiness2.2%709
26. Fatiguetiredness2.2%690
27. Condition aggravatedthe condition being treated got worse2%644
28. Astheniaweakness or lack of energy1.8%587
29. Swelling facea swollen face1.8%574
30. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.8%572

Top 30 of 2,728 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. 25.6% 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 31,984 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amoxicillin 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 Amoxicillin as a suspect or interacting product; reports listing it only as a concomitant medication (44,818) 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.