GENTAMICIN SULFATE

N/A

Manufactured by Fresenius Kabi USA, LLC

27,380 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GENTAMICIN SULFATE

GENTAMICIN SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for GENTAMICIN SULFATE include DRUG INEFFECTIVE, ACUTE KIDNEY INJURY, PYREXIA, OFF LABEL USE, RENAL FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GENTAMICIN SULFATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,182 reports
ACUTE KIDNEY INJURY1,162 reports
PYREXIA881 reports
OFF LABEL USE823 reports
RENAL FAILURE690 reports
DIARRHOEA543 reports
SEPSIS495 reports
CONDITION AGGRAVATED480 reports
HYPOTENSION474 reports
NAUSEA468 reports
RENAL FAILURE ACUTE463 reports
RASH433 reports
CHRONIC KIDNEY DISEASE422 reports
PNEUMONIA421 reports
PRODUCT USE IN UNAPPROVED INDICATION413 reports
DYSPNOEA412 reports
DRUG INTERACTION410 reports
FATIGUE404 reports
FOETAL EXPOSURE DURING PREGNANCY396 reports
MATERNAL EXPOSURE DURING PREGNANCY392 reports
VOMITING381 reports
PREMATURE BABY379 reports
PAIN357 reports
SEPTIC SHOCK352 reports
THROMBOCYTOPENIA348 reports
NEUTROPENIA344 reports
DEATH338 reports
RENAL IMPAIRMENT336 reports
ANAEMIA330 reports
PREMATURE DELIVERY288 reports
DRUG HYPERSENSITIVITY273 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS267 reports
PRURITUS265 reports
RENAL TUBULAR NECROSIS246 reports
MALAISE241 reports
ANXIETY240 reports
BLOOD CREATININE INCREASED240 reports
DIZZINESS240 reports
ANAPHYLACTIC REACTION234 reports
END STAGE RENAL DISEASE224 reports
ABDOMINAL PAIN222 reports
URINARY TRACT INFECTION219 reports
HEADACHE214 reports
DISEASE PROGRESSION212 reports
TACHYCARDIA212 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME211 reports
ARTHRALGIA203 reports
TOXIC EPIDERMAL NECROLYSIS203 reports
DRUG RESISTANCE200 reports
ERYTHEMA196 reports
SEIZURE196 reports
ASTHENIA195 reports
RESPIRATORY FAILURE195 reports
FEBRILE NEUTROPENIA193 reports
PATHOGEN RESISTANCE193 reports
TOXICITY TO VARIOUS AGENTS191 reports
EOSINOPHILIA189 reports
DECREASED APPETITE185 reports
PLATELET COUNT DECREASED185 reports
METABOLIC ACIDOSIS183 reports
PANCYTOPENIA182 reports
MUCOSAL INFLAMMATION179 reports
MULTI ORGAN FAILURE178 reports
NEPHROPATHY TOXIC176 reports
CONFUSIONAL STATE173 reports
OVERDOSE172 reports
CHEST PAIN171 reports
HYPERTENSION171 reports
CELLULITIS168 reports
COUGH165 reports
TUBULOINTERSTITIAL NEPHRITIS162 reports
CARDIAC ARREST161 reports
HYPERSENSITIVITY161 reports
TREATMENT FAILURE161 reports
GENERAL PHYSICAL HEALTH DETERIORATION158 reports
INFECTION158 reports
LEUKOPENIA157 reports
RASH MACULO PAPULAR157 reports
CHILLS155 reports
RENAL INJURY153 reports
WEIGHT DECREASED152 reports
INJURY149 reports
ALOPECIA148 reports
HYPOKALAEMIA145 reports
DEHYDRATION144 reports
HAEMOGLOBIN DECREASED144 reports
NEUROPATHY PERIPHERAL144 reports
PRODUCT USE ISSUE144 reports
BACK PAIN141 reports
PULMONARY EMBOLISM141 reports
BALANCE DISORDER139 reports
OEDEMA PERIPHERAL137 reports
PERITONITIS137 reports
OTOTOXICITY135 reports
ALANINE AMINOTRANSFERASE INCREASED132 reports
STAPHYLOCOCCAL INFECTION132 reports
URTICARIA132 reports
INCORRECT DOSE ADMINISTERED128 reports
ATRIAL FIBRILLATION127 reports
COVID 19127 reports

Report Outcomes

Out of 15,299 classified reports for GENTAMICIN SULFATE:

Serious 92.0%Non-Serious 8.0%

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

Male6,919 (50.7%)
Female6,631 (48.6%)
Unknown102 (0.7%)

Reports by Age

Age 59274 reports
Age 71262 reports
Age 66242 reports
Age 67241 reports
Age 65233 reports
Age 63229 reports
Age 70227 reports
Age 62223 reports
Age 68215 reports
Age 61211 reports
Age 69211 reports
Age 57208 reports
Age 75208 reports
Age 72203 reports
Age 77203 reports
Age 74202 reports
Age 64198 reports
Age 58187 reports
Age 60183 reports
Age 53182 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 GENTAMICIN SULFATE?

This profile reflects 27,380 FDA FAERS reports that mention GENTAMICIN SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GENTAMICIN SULFATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, ACUTE KIDNEY INJURY, PYREXIA, OFF LABEL USE, RENAL FAILURE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GENTAMICIN SULFATE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with GENTAMICIN SULFATE. 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.