What the label lists and what reports show
Cefuroxime side effects
Cefuroxime's FDA label: “The most common adverse reactions (≥3%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease).” FAERS holds 15,670 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 dyspnoea (1,030 reports).
- Generic listed
Check it at the source: the cefuroxime FDA label on DailyMed (effective April 29, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥3%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease).
Table 5. Adverse Reactions (≥1%) after Multiple-Dose Regimens with Cefuroxime Axetil Tablets
| Adverse Reaction | Cefuroxime Axetil (n = 912) |
|---|---|
| Eosinophilia | 1% |
| Diarrhea | 4% |
| Nausea/Vomiting | 3% |
| Transient elevation in AST | 2% |
| Transient elevation in ALT | 2% |
| Transient elevation in LDH | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label: Anaphylactic Reactions [see Warnings and Precautions (5.1)]. The most common adverse reactions (≥3%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tablets Multiple-Dose Dosing Regimens with 7 to 10 Days’ Duration: In multiple-dose clinical trials, 912 subjects were treated with cefuroxime axetil (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. …
Source: FDA drug label, Aurobindo Pharma Limited, effective April 29, 2024 (SPL set faef39e9-d793-4191-a728-310f6fab759d), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,670 reports list cefuroxime among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,686 are coded as a death and 6,881 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 20 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?
- Cefuroxime: 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