Cefazolin sodium: adverse event reports filed with FDA

1,331

reports as suspect product

0% of all reports · about 59 a year

191

reports, 12 months to June 2026

221 in the 12 months before

95.5%

marked serious by the reporter

89.1% across the class

6%

record death among outcomes, as reported

80 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 Cefazolin sodium reports recording the termmedian drug in cephalosporin antibacterial

1. Anaphylactic shocka severe allergic reaction with collapse15.8%210
2. Anaphylactic reactiona severe, sudden allergic reaction9.7%129
3. Hypotensionlow blood pressure7.2%96
4. Rashskin rash5.3%70
5. Tachycardiafast heart rate4%53
6. Urticariahives3.7%49
7. Erythemaskin redness2.9%39
8. Pruritusitching2.9%39
9. Hypersensitivityan allergic-type reaction2.8%37
10. Cardiac arrestthe heart stopped2.7%36
11. Back painback pain2.3%31
12. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.3%31
13. Blood pressure increaseda raised blood pressure reading2.1%28
14. Bronchospasmtightening of the airways2%27
15. Face oedemaswelling of the face2%27
16. Rash maculo-papulara rash of flat and raised spots2%27
17. Haemorrhagebleeding2%26
18. Angiopathy1.9%25
19. Hypovolaemia1.9%25
20. Pneumothoraxa collapsed lung1.9%25
21. Shock haemorrhagic1.9%25
22. Acute generalised exanthematous pustulosis1.8%24
23. Adverse reaction1.8%24
24. Emphysema1.8%24
25. Epistaxisnosebleed1.8%24
26. Flatulencewind1.8%24
27. Haemothorax1.8%24
28. Hepatic cytolysis1.8%24
29. Inspiratory capacity decreased1.8%24
30. Mechanical ventilation complication1.8%24

Top 30 of 347 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. 11.5% 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 1,331 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 Cefazolin sodium as a suspect or interacting product; reports listing it only as a concomitant medication (1,707) 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.