amikacin Side Effects
Also known as: Amikin
Analysis of 16,238 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
16,238
Death-Related
3,283
20.2% of reports
Hospitalizations
6,935
42.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 3,283 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,103 |
| DRUG INEFFECTIVE | 553 |
| OFF LABEL USE | 330 |
| DYSPNOEA | 277 |
| SEPTIC SHOCK | 266 |
| THERAPY INTERRUPTED | 220 |
| PNEUMONIA | 214 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 203 |
| HOSPITALISATION | 189 |
| COUGH | 188 |
| SEPSIS | 162 |
| RESPIRATORY FAILURE | 157 |
| PYREXIA | 141 |
| CONDITION AGGRAVATED | 113 |
| PRODUCT DOSE OMISSION ISSUE | 109 |
| ASTHENIA | 105 |
| CARDIAC ARREST | 97 |
| DRUG RESISTANCE | 97 |
| THROMBOCYTOPENIA | 95 |
| FATIGUE | 94 |
Reactions in Hospitalization Reports
Top reactions in 6,935 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 1,360 |
| THERAPY INTERRUPTED | 1,038 |
| OFF LABEL USE | 826 |
| DYSPNOEA | 821 |
| DRUG INEFFECTIVE | 799 |
| COUGH | 741 |
| PNEUMONIA | 519 |
| PRODUCT DOSE OMISSION ISSUE | 465 |
| PYREXIA | 423 |
| DEATH | 401 |
| DYSPHONIA | 362 |
| NAUSEA | 348 |
| DIARRHOEA | 334 |
| FATIGUE | 303 |
| PRODUCTIVE COUGH | 277 |
| ASTHENIA | 274 |
| MALAISE | 269 |
| ACUTE KIDNEY INJURY | 264 |
| CONDITION AGGRAVATED | 262 |
| THROMBOCYTOPENIA | 256 |
Nearby — Related Medications
What the FAERS Data Reveals About amikacin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 16,238 voluntary reports linked to amikacin and its brand equivalents (Amikin), spanning 2004 through 2025. Of those, 3,283 (20.2%) listed death as an outcome and 6,935 (42.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 54% were female and 46% male; age distribution skews toward 45-64, with 2,877 reports in that bracket. The single most reported reaction is off label use with 1,908 submissions, followed by drug ineffective and cough.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.