Ampicillin sodium, sulbactam sodium: adverse event reports filed with FDA

567

reports as suspect product

0% of all reports · about 40 a year

77

reports, 12 months to June 2026

128 in the 12 months before

92.9%

marked serious by the reporter

81% across the class

18.9%

record death among outcomes, as reported

107 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 Ampicillin sodium, sulbactam sodium reports recording the termmedian drug in penicillin-class antibacterial

1. Drug ineffectivethe medicine did not work as expected24.7%140
2. Off label useused for a purpose or in a way not on the label10.6%60
3. Condition aggravatedthe condition being treated got worse6.2%35
4. Diarrhoealoose or frequent stools5.6%32
5. Pneumonialung infection4.8%27
6. Acute kidney injurysudden loss of kidney function4.6%26
7. Drug ineffective for unapproved indication4.6%26
8. Rashskin rash3.7%21
9. Pyrexiafever3.5%20
10. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement3.4%19
11. Candida infectionthrush, a yeast infection2.5%14
12. Drug eruption2.5%14
13. Multiple organ dysfunction syndromeseveral organs failing2.5%14
14. Hypokalaemialow blood potassium2.3%13
15. Premature babya baby born early2.3%13
16. Treatment failurethe treatment did not work2.3%13
17. Drug resistance2.1%12
18. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.1%12
19. Stevens-Johnson syndromea severe skin and mucous-membrane reaction2.1%12
20. Drug-induced liver injury1.9%11
21. Foetal exposure during pregnancythe unborn baby was exposed to the medicine1.9%11
22. Deaththe patient died; cause not stated by this term1.8%10
23. Erythemaskin redness1.8%10
24. Pruritusitching1.8%10
25. Respiratory failurethe lungs could not supply enough oxygen1.8%10
26. Toxic epidermal necrolysisa severe skin reaction with peeling1.8%10
27. Product use in unapproved indicationused for a purpose not on the label1.6%9
28. Vomitingbeing sick1.6%9
29. Exposure during pregnancythe medicine was taken during pregnancy1.4%8
30. Renal failurekidney failure1.4%8

Top 30 of 193 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 15 drugs in the penicillin-class 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 64,409 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. 39.9% 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 567 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 penicillin-class 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 Ampicillin sodium, sulbactam sodium as a suspect or interacting product; reports listing it only as a concomitant medication (711) 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.