Cefepime hydrochloride: adverse event reports filed with FDA

1,021

reports as suspect product

0% of all reports · about 45 a year

51

reports, 12 months to June 2026

102 in the 12 months before

86.6%

marked serious by the reporter

89.1% across the class

16.7%

record death among outcomes, as reported

170 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 Cefepime hydrochloride reports recording the termmedian drug in cephalosporin antibacterial

1. Acute kidney injurysudden loss of kidney function9.2%94
2. Drug ineffectivethe medicine did not work as expected9.2%94
3. Drug hypersensitivityan allergic-type reaction to a medicine8.4%86
4. Encephalopathy5.3%54
5. Off label useused for a purpose or in a way not on the label4.8%49
6. Rashskin rash4.6%47
7. Confusional stateconfusion4.5%46
8. Neurotoxicity4%41
9. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement3.5%36
10. Pyrexiafever3.3%34
11. Febrile neutropeniafever with low white blood cells3.2%33
12. Neutropenialow neutrophils, a type of white blood cell2.7%28
13. Thrombocytopenialow platelets2.4%24
14. Pneumonialung infection2.2%22
15. Septic shockshock arising from infection2%20
16. Condition aggravatedthe condition being treated got worse1.9%19
17. Tubulointerstitial nephritis1.9%19
18. Deliriumsudden confusion1.8%18
19. Mental status changes1.8%18
20. Renal failurekidney failure1.8%18
21. Acute generalised exanthematous pustulosis1.7%17
22. Hypotensionlow blood pressure1.7%17
23. Status epilepticus1.7%17
24. Pruritusitching1.6%16
25. Toxicity to various agentspoisoning or toxic effect of one or more substances1.6%16
26. Blood creatinine increasedraised creatinine, a kidney test1.5%15
27. Clostridium difficile colitisa bowel infection with C. difficile1.5%15
28. Agranulocytosis1.3%13
29. Seizurea fit or convulsion1.3%13
30. Drug ineffective for unapproved indication1.2%12

Top 30 of 272 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 17 drugs in the cephalosporin 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 57,006 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. 59.5% 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 1,021 reports.

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 cephalosporin 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 Cefepime hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,079) 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.