Imipenem and cilastatin sodium: adverse event reports filed with FDA

1,276

reports as suspect product

0% of all reports · about 57 a year

10

reports, 12 months to June 2026

8 in the 12 months before

96.2%

marked serious by the reporter

94.1% across the class

25.6%

record death among outcomes, as reported

327 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 Imipenem and cilastatin sodium reports recording the termmedian drug in penem antibacterial

1. Convulsion13.6%173
2. Drug ineffectivethe medicine did not work as expected6.4%82
3. Pyrexiafever4.5%58
4. Deaththe patient died; cause not stated by this term4.5%57
5. Sepsisa severe body-wide response to infection4.1%52
6. Rashskin rash3.4%43
7. Multi-organ failure3.3%42
8. Pneumonialung infection3.1%40
9. Septic shockshock arising from infection3.1%39
10. Thrombocytopenialow platelets3.1%39
11. Grand mal convulsion2.7%34
12. Renal failurekidney failure2.6%33
13. Renal failure acute2.3%29
14. Pruritusitching2.2%28
15. Drug interactionan interaction between medicines1.9%24
16. Pancytopenialow counts of all blood cells1.7%22
17. Aspartate aminotransferase increasedraised liver enzyme (AST)1.6%21
18. Condition aggravatedthe condition being treated got worse1.6%21
19. Drug rash with eosinophilia and systemic symptoms1.6%21
20. Erythemaskin redness1.6%21
21. Respiratory failurethe lungs could not supply enough oxygen1.6%21
22. Stevens-Johnson syndromea severe skin and mucous-membrane reaction1.6%21
23. Alanine aminotransferase increasedraised liver enzyme (ALT)1.6%20
24. Toxic epidermal necrolysisa severe skin reaction with peeling1.6%20
25. Gamma-glutamyltransferase increased1.5%19
26. Epilepsy1.4%18
27. Anaemialow red blood cells1.3%17
28. Cytolytic hepatitis1.3%16
29. Diarrhoealoose or frequent stools1.3%16
30. Agranulocytosis1.2%15

Top 30 of 275 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. 20.2% 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 1,276 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 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 Imipenem and cilastatin sodium as a suspect or interacting product; reports listing it only as a concomitant medication (529) 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.