Neomycin sulfate: adverse event reports filed with FDA

770

reports as suspect product

0% of all reports · about 47 a year

57

reports, 12 months to June 2026

115 in the 12 months before

59.4%

marked serious by the reporter

80.3% across the class

22.1%

record death among outcomes, as reported

170 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 Neomycin sulfate reports recording the termmedian drug in aminoglycoside antibacterial

1. Drug hypersensitivityan allergic-type reaction to a medicine51.6%397
2. Drug ineffectivethe medicine did not work as expected43.8%337
3. Off label useused for a purpose or in a way not on the label28.3%218
4. Painpain, site not specified28.2%217
5. Nauseafeeling sick27.5%212
6. Infusion related reactiona reaction during or soon after an infusion27.1%209
7. Therapeutic product effect incomplete25.2%194
8. Macular degenerationa disease of the central retina22.9%176
9. Rashskin rash20.8%160
10. Dyspnoeashortness of breath20.1%155
11. Type 2 diabetes mellitustype 2 diabetes19.9%153
12. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease19.5%150
13. Swellingswelling18.6%143
14. Therapeutic product effect decreased18.6%143
15. Product use in unapproved indicationused for a purpose not on the label17.8%137
16. Systemic lupus erythematosuslupus, an autoimmune disease17.4%134
17. C-reactive protein increased17.3%133
18. Psoriatic arthropathy17.3%133
19. Treatment failurethe treatment did not work16.8%129
20. Malaisegeneral feeling of being unwell16.5%127
21. Contraindicated product administered16.2%125
22. Confusional stateconfusion16.1%124
23. Sleep disordera sleep problem16.1%124
24. Headachehead pain16%123
25. Product use issuea problem in how the product was used16%123
26. Synovitis16%123
27. Wound16%123
28. C-reactive protein abnormal15.7%121
29. Pemphigus15.7%121
30. Pericarditisinflammation of the sac around the heart15.7%121

Top 30 of 341 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 aminoglycoside 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 37,840 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. 43% 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 770 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 aminoglycoside 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 Neomycin sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (438) 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.