AMIKACIN

N/A

Manufactured by Insmed Incorporated

37,285 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMIKACIN

AMIKACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Insmed Incorporated. The most commonly reported adverse reactions for AMIKACIN include OFF LABEL USE, DRUG INEFFECTIVE, COUGH, DYSPNOEA, HOSPITALISATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMIKACIN.

Top Adverse Reactions

OFF LABEL USE1,908 reports
DRUG INEFFECTIVE1,673 reports
COUGH1,620 reports
DYSPNOEA1,556 reports
HOSPITALISATION1,360 reports
THERAPY INTERRUPTED1,348 reports
DEATH1,103 reports
DYSPHONIA977 reports
PRODUCT DOSE OMISSION ISSUE730 reports
NAUSEA721 reports
FATIGUE702 reports
PNEUMONIA649 reports
DIARRHOEA634 reports
PYREXIA632 reports
PRODUCTIVE COUGH598 reports
CONDITION AGGRAVATED565 reports
DRUG RESISTANCE554 reports
PRODUCT USE IN UNAPPROVED INDICATION507 reports
APHONIA491 reports
VOMITING465 reports
ASTHENIA451 reports
HAEMOPTYSIS448 reports
THROMBOCYTOPENIA439 reports
MALAISE433 reports
ACUTE KIDNEY INJURY419 reports
SEPTIC SHOCK402 reports
WEIGHT DECREASED400 reports
DRUG INTOLERANCE398 reports
DEAFNESS341 reports
TINNITUS333 reports
MYCOBACTERIUM AVIUM COMPLEX INFECTION332 reports
OXYGEN SATURATION DECREASED330 reports
HEADACHE328 reports
INTENTIONAL DOSE OMISSION323 reports
SEPSIS323 reports
DRUG INTERACTION318 reports
OROPHARYNGEAL PAIN317 reports
DECREASED APPETITE314 reports
ANAEMIA313 reports
RASH304 reports
DIZZINESS297 reports
ADVERSE DRUG REACTION296 reports
DEVICE ISSUE290 reports
NEUTROPENIA270 reports
ILLNESS267 reports
FEBRILE NEUTROPENIA257 reports
RESPIRATORY FAILURE251 reports
LUNG DISORDER250 reports
CHEST DISCOMFORT242 reports
RENAL FAILURE239 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS237 reports
PATHOGEN RESISTANCE237 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME234 reports
DRUG DOSE OMISSION BY DEVICE233 reports
ELECTROCARDIOGRAM QT PROLONGED233 reports
HYPOTENSION226 reports
TREATMENT FAILURE218 reports
DYSGEUSIA211 reports
PANCYTOPENIA210 reports
NEUROPATHY PERIPHERAL208 reports
UNEVALUABLE EVENT206 reports
SPUTUM INCREASED204 reports
THROAT IRRITATION200 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION199 reports
CHEST PAIN188 reports
ABDOMINAL PAIN187 reports
HYPOACUSIS179 reports
GENERAL PHYSICAL HEALTH DETERIORATION176 reports
PRURITUS172 reports
COVID 19171 reports
GASTROINTESTINAL DISORDER171 reports
OTOTOXICITY170 reports
DISEASE PROGRESSION168 reports
LEUKOPENIA168 reports
RASH MACULO PAPULAR165 reports
RENAL IMPAIRMENT165 reports
BRONCHOSPASM164 reports
INFECTION160 reports
TACHYCARDIA155 reports
MYCOBACTERIUM ABSCESSUS INFECTION154 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE153 reports
CANDIDA INFECTION152 reports
FEELING ABNORMAL149 reports
PAIN149 reports
SPUTUM DISCOLOURED149 reports
PSEUDOMONAS INFECTION148 reports
ABDOMINAL DISCOMFORT146 reports
HEPATOTOXICITY146 reports
ABDOMINAL PAIN UPPER142 reports
RESPIRATORY DISTRESS141 reports
SECRETION DISCHARGE141 reports
TOXICITY TO VARIOUS AGENTS137 reports
PRODUCT DOSE OMISSION136 reports
INSOMNIA135 reports
WHEEZING134 reports
ARTHRALGIA132 reports
CONFUSIONAL STATE130 reports
EOSINOPHILIA127 reports
DRUG HYPERSENSITIVITY126 reports
DYSPNOEA EXERTIONAL125 reports

Report Outcomes

Out of 16,231 classified reports for AMIKACIN:

Serious 82.2%Non-Serious 17.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female8,077 (54.2%)
Male6,794 (45.6%)
Unknown41 (0.3%)

Reports by Age

Age 64238 reports
Age 68235 reports
Age 70235 reports
Age 72230 reports
Age 65221 reports
Age 69215 reports
Age 58211 reports
Age 76200 reports
Age 55195 reports
Age 62194 reports
Age 71189 reports
Age 61188 reports
Age 75184 reports
Age 73182 reports
Age 67179 reports
Age 77178 reports
Age 57176 reports
Age 60175 reports
Age 66163 reports
Age 59160 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AMIKACIN?

This profile reflects 37,285 FDA FAERS reports that mention AMIKACIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMIKACIN?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, COUGH, DYSPNOEA, HOSPITALISATION, THERAPY INTERRUPTED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMIKACIN?

Labeling and FAERS entries often list Insmed Incorporated in connection with AMIKACIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.