Amikacin: adverse event reports filed with FDA

5,380

reports as suspect product

0% of all reports · about 239 a year

531

reports, 12 months to June 2026

516 in the 12 months before

91.9%

marked serious by the reporter

80.3% across the class

19.7%

record death among outcomes, as reported

1,061 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 reports recording the termmedian drug in aminoglycoside antibacterial

1. Drug ineffectivethe medicine did not work as expected17.4%936
2. Off label useused for a purpose or in a way not on the label9%483
3. Drug resistance6.9%369
4. Condition aggravatedthe condition being treated got worse5.8%314
5. Acute kidney injurysudden loss of kidney function5.2%278
6. Nauseafeeling sick4.3%233
7. Product use in unapproved indicationused for a purpose not on the label4.1%223
8. Thrombocytopenialow platelets4.1%222
9. Septic shockshock arising from infection3.7%201
10. Deafnesshearing loss3.5%188
11. Pyrexiafever3.4%185
12. Drug intolerancethe medicine was not tolerated3.2%172
13. Treatment failurethe treatment did not work3.1%168
14. Diarrhoealoose or frequent stools3%159
15. Electrocardiogram QT prolongeda QT prolongation on the ECG2.9%157
16. Pathogen resistance2.9%156
17. Ototoxicity2.9%154
18. Vomitingbeing sick2.7%147
19. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.7%145
20. Multiple organ dysfunction syndromeseveral organs failing2.6%142
21. Dyspnoeashortness of breath2.6%138
22. Drug interactionan interaction between medicines2.5%136
23. Anaemialow red blood cells2.5%132
24. Pneumonialung infection2.3%125
25. Coughcough2.3%123
26. Drug ineffective for unapproved indication2.2%119
27. Renal failurekidney failure2.2%118
28. Mycobacterium avium complex infection2.1%114
29. Rashskin rash2.1%112
30. Sepsisa severe body-wide response to infection2%106

Top 30 of 968 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. 28.6% 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 5,380 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amikacin 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."

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 as a suspect or interacting product; reports listing it only as a concomitant medication (5,194) 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.