Ceftriaxone: adverse event reports filed with FDA

17,155

reports as suspect product

0.1% of all reports · about 763 a year

1,294

reports, 12 months to June 2026

1,546 in the 12 months before

93.7%

marked serious by the reporter

89.1% across the class

15.4%

record death among outcomes, as reported

2,646 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 Ceftriaxone reports recording the termmedian drug in cephalosporin antibacterial

1. Off label useused for a purpose or in a way not on the label12.5%2,143
2. Drug ineffectivethe medicine did not work as expected11.5%1,979
3. Condition aggravatedthe condition being treated got worse5.4%920
4. Pyrexiafever4.4%755
5. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement4%683
6. Dyspnoeashortness of breath3.7%637
7. Rashskin rash3.6%613
8. Acute kidney injurysudden loss of kidney function3.6%610
9. Vomitingbeing sick3.2%554
10. Nauseafeeling sick2.8%486
11. Hypotensionlow blood pressure2.6%453
12. Product use in unapproved indicationused for a purpose not on the label2.6%452
13. Pruritusitching2.6%440
14. Diarrhoealoose or frequent stools2.5%434
15. Drug hypersensitivityan allergic-type reaction to a medicine2.5%434
16. Multiple organ dysfunction syndromeseveral organs failing2.5%434
17. Drug interactionan interaction between medicines2.5%430
18. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.4%414
19. Abdominal painstomach or belly pain2.4%404
20. Sepsisa severe body-wide response to infection2.2%376
21. Anaphylactic reactiona severe, sudden allergic reaction2.2%370
22. Neutropenialow neutrophils, a type of white blood cell2.1%362
23. Thrombocytopenialow platelets2.1%359
24. Anaemialow red blood cells2.1%354
25. Urticariahives2%341
26. Toxic epidermal necrolysisa severe skin reaction with peeling1.9%333
27. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.9%332
28. Pneumonialung infection1.9%326
29. Exposure during pregnancythe medicine was taken during pregnancy1.9%325
30. Rash maculo-papulara rash of flat and raised spots1.9%324

Top 30 of 1,937 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. 29.7% 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 17,155 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ceftriaxone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Ceftriaxone as a suspect or interacting product; reports listing it only as a concomitant medication (15,925) 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.