What the label lists and what reports show
Amoxicillin side effects
Amoxicillin's FDA label: “The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea.” FAERS holds 75,926 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 chronic kidney disease (4,668 reports).
- Generic listed
Check it at the source: the amoxicillin FDA label on DailyMed (effective February 22, 2024, Sandoz Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea.
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 )] • Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea. ( 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 Trials 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 common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). …
Source: FDA drug label, Sandoz Inc, effective February 22, 2024 (SPL set 13bd4214-9b7f-425b-af5f-fc1ddc678230), via openFDA; the full label on DailyMed
What do FAERS reports show?
75,926 reports list amoxicillin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,023 are coded as a death and 27,897 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, 9 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: 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