What the label lists and what reports show
Ceftaroline side effects
Ceftaroline's FDA label: “The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.” FAERS holds 808 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 neutropenia (74 reports).
- Generic listed
Check it at the source: the ceftaroline FDA label on DailyMed (effective May 29, 2026, Apotex Corp.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Adverse Reactions Ceftaroline Fosamil for Injection (N=1,300) | Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP) Pooled Comparators a (N=1,297) |
|---|---|---|
| Diarrhea | 5 % | 3 % |
| Nausea | 4 % | 4 % |
| Constipation | 2 % | 2 % |
| Vomiting | 2 % | 2 % |
| Increased transaminases | 2% | 3 % |
| Hypokalemia | 2 % | 3 % |
| Rash | 3% | 2% |
| Phlebitis | 2% | 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, continuedADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated diarrhea [see Warnings and Precautions ( 5.2 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.3 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash. Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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 clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. …
Source: FDA drug label, Apotex Corp., effective May 29, 2026 (SPL set 3cee3c08-ed60-06c5-ac49-103b7ad2ef5f), via openFDA; the full label on DailyMed
What do FAERS reports show?
808 reports list ceftaroline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 151 are coded as a death and 312 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, 13 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?
- Ceftaroline: 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