Piperacillin sodium,tazobactam sodium: adverse event reports filed with FDA

7,533

reports as suspect product

0% of all reports · about 429 a year

1,389

reports, 12 months to June 2026

1,304 in the 12 months before

98.2%

marked serious by the reporter

57.4% across all reports

17.9%

record death among outcomes, as reported

1,347 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 Piperacillin sodium,tazobactam sodium reports recording the termall reports in the database

1. Drug ineffectivethe medicine did not work as expected14%1,056
2. Off label useused for a purpose or in a way not on the label11.1%838
3. Acute kidney injurysudden loss of kidney function8.6%645
4. Condition aggravatedthe condition being treated got worse5.9%442
5. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement5.6%425
6. Rashskin rash4.1%312
7. Pyrexiafever4%305
8. Thrombocytopenialow platelets3.5%266
9. Rash maculo-papulara rash of flat and raised spots3.3%251
10. Diarrhoealoose or frequent stools3.2%241
11. Neutropenialow neutrophils, a type of white blood cell2.9%220
12. Eosinophilia2.9%216
13. Drug ineffective for unapproved indication2.7%205
14. Multiple organ dysfunction syndromeseveral organs failing2.7%204
15. Hepatic cytolysis2.7%201
16. Toxic epidermal necrolysisa severe skin reaction with peeling2.6%193
17. Cholestasis2.4%179
18. Dyspnoeashortness of breath2.3%172
19. Septic shockshock arising from infection2.3%172
20. Clostridium difficile colitisa bowel infection with C. difficile2.2%168
21. Nauseafeeling sick2.2%166
22. Respiratory failurethe lungs could not supply enough oxygen1.9%143
23. Pruritusitching1.9%142
24. Drug interactionan interaction between medicines1.9%141
25. Pancytopenialow counts of all blood cells1.8%133
26. Pneumonialung infection1.8%133
27. Sepsisa severe body-wide response to infection1.7%128
28. Vomitingbeing sick1.7%127
29. Hypotensionlow blood pressure1.6%123
30. Drug hypersensitivityan allergic-type reaction to a medicine1.5%116

Top 30 of 1,049 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 share of all reports in the database; 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 20,646,523 reports. 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. 14.1% 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 7,533 reports.

Drugs most often listed in the same reports

Other products listed in reports where Piperacillin sodium,tazobactam 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."

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 Piperacillin sodium,tazobactam sodium as a suspect or interacting product; reports listing it only as a concomitant medication (6,221) 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.