Amikacin sulfate: adverse event reports filed with FDA

828

reports as suspect product

0% of all reports · about 37 a year

49

reports, 12 months to June 2026

68 in the 12 months before

93.5%

marked serious by the reporter

80.3% across the class

19.4%

record death among outcomes, as reported

161 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 Amikacin sulfate reports recording the termmedian drug in aminoglycoside antibacterial

1. Drug ineffectivethe medicine did not work as expected14.3%118
2. Off label useused for a purpose or in a way not on the label9.1%75
3. Pyrexiafever8.9%74
4. Drug resistance6.2%51
5. Acute kidney injurysudden loss of kidney function5.2%43
6. Condition aggravatedthe condition being treated got worse5.1%42
7. Nauseafeeling sick5.1%42
8. Vomitingbeing sick3.9%32
9. Thrombocytopenialow platelets3.7%31
10. Dyspnoeashortness of breath3.6%30
11. Product use in unapproved indicationused for a purpose not on the label3.4%28
12. Ototoxicity3%25
13. Diarrhoealoose or frequent stools2.9%24
14. Drug interactionan interaction between medicines2.9%24
15. Sepsisa severe body-wide response to infection2.9%24
16. Somnolencedrowsiness2.9%24
17. Pathogen resistance2.7%22
18. Cardiovascular disorder2.5%21
19. Deafnesshearing loss2.5%21
20. General physical health deteriorationgeneral decline in health2.5%21
21. Heart rate increaseda fast heart rate reading2.5%21
22. Performance status decreased2.5%21
23. Multiple organ dysfunction syndromeseveral organs failing2.4%20
24. C-reactive protein increased2.3%19
25. Deaththe patient died; cause not stated by this term2.3%19
26. Dizzinesslight-headedness or unsteadiness2.3%19
27. Rashskin rash2.3%19
28. Neutropenialow neutrophils, a type of white blood cell2.2%18
29. Astheniaweakness or lack of energy2.1%17
30. Chest painchest pain2.1%17

Top 30 of 328 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. 19.6% 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 828 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 Amikacin sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (880) 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.