What the label lists and what reports show
Amoxicillin and clavulanate side effects
Amoxicillin and clavulanate's FDA label: “The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).” FAERS holds 27,019 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,880 reports).
- Generic listed
Check it at the source: the amoxicillin and clavulanate FDA label on DailyMed (effective May 1, 2025, Sandoz Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).
From the label: adverse reactions, continuedThe following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] • Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] • Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions. …
Source: FDA drug label, Sandoz Inc, effective May 1, 2025 (SPL set 7cba82f0-9886-46e9-8dbd-43a448aade29), via openFDA; the full label on DailyMed
What do FAERS reports show?
27,019 reports list amoxicillin and clavulanate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,605 are coded as a death and 13,277 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amoxicillin and clavulanate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions