Ertapenem sodium: adverse event reports filed with FDA

1,073

reports as suspect product

0% of all reports · about 56 a year

36

reports, 12 months to June 2026

48 in the 12 months before

96.2%

marked serious by the reporter

94.1% across the class

3.6%

record death among outcomes, as reported

39 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 Ertapenem sodium reports recording the termmedian drug in penem antibacterial

1. Drug ineffectivethe medicine did not work as expected64%687
2. Macular degenerationa disease of the central retina61.6%661
3. Pyrexiafever17.6%189
4. Off label useused for a purpose or in a way not on the label16%172
5. Painpain, site not specified15.8%169
6. Therapeutic product effect incomplete15.8%169
7. Chronic sinusitis15.6%167
8. Malaisegeneral feeling of being unwell15.6%167
9. Nauseafeeling sick15.6%167
10. Paraesthesia oral15.6%167
11. Weight decreasedweight loss15.6%167
12. Infusion related reactiona reaction during or soon after an infusion15.2%163
13. Dyspepsiaindigestion14.5%156
14. Procedural painpain from a procedure14.4%155
15. Anaemialow red blood cells12.4%133
16. Erythemaskin redness11.4%122
17. Constipationconstipation11.3%121
18. Female genital tract fistula11.3%121
19. Abdominal painstomach or belly pain11.2%120
20. Colitisinflamed bowel11.2%120
21. Frequent bowel movements11.2%120
22. Haematocheziablood in the stool11.2%120
23. Headachehead pain11.2%120
24. Oral candidiasisoral thrush11.1%119
25. Radiculopathy11.1%119
26. Rectal haemorrhage11.1%119
27. Vaginal discharge11.1%119
28. Vaginal flatulence11.1%119
29. Colitis ulcerative11%118
30. Proctitis11%118

Top 30 of 179 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 6 drugs in the penem 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 23,429 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. 6.4% 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 1,073 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ertapenem sodium 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 penem 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 Ertapenem sodium as a suspect or interacting product; reports listing it only as a concomitant medication (103) 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.