GENTAMICIN SULFATE

Gentamicin Sulfate Adverse Events Reported to the FDA Over Time

How are Gentamicin Sulfate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Gentamicin Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Gentamicin Sulfate is flagged as the suspect drug causing the adverse event.

Most Common Gentamicin Sulfate Adverse Events Reported to the FDA

What are the most common Gentamicin Sulfate adverse events reported to the FDA?

Renal Failure Acute	73 (5.22%)
Balance Disorder	17 (1.22%)
Drug Rash With Eosinophilia And Sys...	16 (1.14%)
Dizziness	13 (.93%)
Drug Interaction	13 (.93%)
Renal Failure	13 (.93%)
Renal Tubular Necrosis	12 (.86%)
Vision Blurred	12 (.86%)
Condition Aggravated	11 (.79%)
Multi-organ Failure	11 (.79%)
Toxic Epidermal Necrolysis	11 (.79%)
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Fall	10 (.72%)
Rash	10 (.72%)
Anaphylactic Reaction	9 (.64%)
Deafness	9 (.64%)
Metabolic Acidosis	9 (.64%)
Pyrexia	9 (.64%)
Vestibular Disorder	9 (.64%)
Cataract	8 (.57%)
Eye Irritation	8 (.57%)
Haematoma	8 (.57%)
Hypotension	8 (.57%)
Myocardial Infarction	8 (.57%)
Ototoxicity	8 (.57%)
Vomiting	8 (.57%)
Clostridial Infection	7 (.5%)
Contusion	7 (.5%)
Disorientation	7 (.5%)
Drug Hypersensitivity	7 (.5%)
Dry Eye	7 (.5%)
Erythema	7 (.5%)
Haemodialysis	7 (.5%)
Impaired Driving Ability	7 (.5%)
Inner Ear Disorder	7 (.5%)
Vertigo	7 (.5%)
Visual Acuity Reduced	7 (.5%)
Amnesia	6 (.43%)
Anaemia	6 (.43%)
Drug Exposure During Pregnancy	6 (.43%)
Gait Disturbance	6 (.43%)
Haemoglobin Decreased	6 (.43%)
Medication Error	6 (.43%)
Tubulointerstitial Nephritis	6 (.43%)
Alanine Aminotransferase Increased	5 (.36%)
Aphasia	5 (.36%)
Ataxia	5 (.36%)
Blood Bilirubin Increased	5 (.36%)
Brain Oedema	5 (.36%)
Cellulitis	5 (.36%)
Drug Ineffective	5 (.36%)
Drug Level Increased	5 (.36%)
Encephalopathy	5 (.36%)
Eye Pain	5 (.36%)
Foreign Body Sensation In Eyes	5 (.36%)
Hepatic Function Abnormal	5 (.36%)
Hypersensitivity	5 (.36%)
Hypoaesthesia	5 (.36%)
International Normalised Ratio Abno...	5 (.36%)
Melaena	5 (.36%)
Neutropenia	5 (.36%)
Ocular Discomfort	5 (.36%)
Overdose	5 (.36%)
Pain	5 (.36%)
Post Procedural Complication	5 (.36%)
Sepsis	5 (.36%)
Septic Shock	5 (.36%)
Stevens-johnson Syndrome	5 (.36%)
Wound	5 (.36%)
Wrong Drug Administered	5 (.36%)
Activities Of Daily Living Impaired	4 (.29%)
Agranulocytosis	4 (.29%)
Blood Creatinine Increased	4 (.29%)
Cerebrovascular Accident	4 (.29%)
Cholestasis	4 (.29%)
Cognitive Disorder	4 (.29%)
Corneal Deposits	4 (.29%)
Dermatitis Contact	4 (.29%)
Diarrhoea	4 (.29%)
Disturbance In Attention	4 (.29%)
Drug Administration Error	4 (.29%)
Drug Dispensing Error	4 (.29%)
Encephalitis	4 (.29%)
Eye Disorder	4 (.29%)
Gamma-glutamyltransferase Increased	4 (.29%)
General Physical Health Deteriorati...	4 (.29%)
Head Injury	4 (.29%)
Heart Rate Increased	4 (.29%)
Hypokalaemia	4 (.29%)
Hypotonia	4 (.29%)
Incorrect Route Of Drug Administrat...	4 (.29%)
Insomnia	4 (.29%)
International Normalised Ratio Incr...	4 (.29%)
Lacrimation Increased	4 (.29%)
Lethargy	4 (.29%)
Leukocyturia	4 (.29%)
Liver Abscess	4 (.29%)
Malaise	4 (.29%)
Malignant Neoplasm Of Eye	4 (.29%)
Maternal Drugs Affecting Foetus	4 (.29%)
Movement Disorder	4 (.29%)
Nausea	4 (.29%)

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This graph shows the top adverse events submitted to the FDA for Gentamicin Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gentamicin Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Gentamicin Sulfate

What are the most common Gentamicin Sulfate adverse events reported to the FDA?

Renal Disorders	108 (7.73%)
Epidermal And Dermal Conditions	98 (7.01%)
Neurological	73 (5.22%)
Infections - Pathogen Unspecified	51 (3.65%)
Bacterial Infectious	43 (3.08%)
Injuries	40 (2.86%)
Ocular Infections, Irritations And ...	32 (2.29%)
Eye	31 (2.22%)
Medication Errors	30 (2.15%)
Hematology Investigations	29 (2.07%)
Inner Ear And Viiith Cranial Nerve	29 (2.07%)
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Vision	28 (2%)
Hepatic And Hepatobiliary	25 (1.79%)
Allergic Conditions	22 (1.57%)
Therapeutic And Nontherapeutic Effe...	22 (1.57%)
Lifestyle Issues	20 (1.43%)
Movement Disorders	20 (1.43%)
Gastrointestinal Signs	19 (1.36%)
Hepatobiliary	19 (1.36%)
Anterior Eye Structural Change, Dep...	18 (1.29%)
Hearing	18 (1.29%)
Nephropathies	15 (1.07%)
White Blood Cell	15 (1.07%)
Aural	14 (1%)
Chemical Injury And Poisoning	14 (1%)
Mental Impairment	14 (1%)
Retina, Choroid And Vitreous Hemorr...	13 (.93%)
Deliria	12 (.86%)
Respiratory	12 (.86%)
Acid-base	11 (.79%)
Body Temperature Conditions	11 (.79%)
Seizures	11 (.79%)
Anemias Nonhemolytic And Marrow Dep...	10 (.72%)
Cardiac And Vascular Investigations	10 (.72%)
Central Nervous System Vascular	10 (.72%)
Coronary Artery	10 (.72%)
Decreased And Nonspecific Blood Pre...	10 (.72%)
Gastrointestinal Motility And Defec...	10 (.72%)
Hematological And Lymphoid Tissue T...	10 (.72%)
Electrolyte And Fluid Balance Condi...	9 (.64%)
Procedural And Device Related Injur...	9 (.64%)
Urinary Tract Signs	9 (.64%)
Anxiety Disorders	8 (.57%)
Increased Intracranial Pressure And...	8 (.57%)
Musculoskeletal And Connective Tiss...	8 (.57%)
Neurological, Special Senses And Ps...	8 (.57%)
Vascular Hemorrhagic	8 (.57%)
Cardiac Arrhythmias	7 (.5%)
Joint	7 (.5%)
Ocular Neuromuscular	7 (.5%)
Fungal Infectious	6 (.43%)
Gastrointestinal Hemorrhages	6 (.43%)
Immune	6 (.43%)
Microbiology And Serology	6 (.43%)
Muscle	6 (.43%)
Obstetric And Gynecological Therape...	6 (.43%)
Ocular Sensory Symptoms	6 (.43%)
Platelet	6 (.43%)
Renal And Urinary Tract Investigati...	6 (.43%)
Toxicology And Therapeutic Drug Mon...	6 (.43%)
Administration Site Reactions	5 (.36%)
Central Nervous System Infections A...	5 (.36%)
Encephalopathies	5 (.36%)
Lower Respiratory Tract Disorders	5 (.36%)
Neuromuscular	5 (.36%)
Peripheral Neuropathies	5 (.36%)
Physical Examination Topics	5 (.36%)
Sleep Disorders	5 (.36%)
Spleen, Lymphatic And Reticulendoth...	5 (.36%)
Vascular	5 (.36%)
Adrenal Gland	4 (.29%)
Angiedema And Urticaria	4 (.29%)
Appetite And General Nutritional	4 (.29%)
Cognitive And Attention Disorders	4 (.29%)
Enzyme	4 (.29%)
Gastrointestinal Inflammatory Condi...	4 (.29%)
Ocular Neoplasms	4 (.29%)
Ocular Structural Change, Deposit A...	4 (.29%)
Placental, Amniotic And Cavity Diso...	4 (.29%)
Pleural	4 (.29%)
Structural Brain	4 (.29%)
Viral Infectious	4 (.29%)
Abdominal Hernias And Other Abdomin...	3 (.21%)
Bronchial Disorders	3 (.21%)
Coagulopathies And Bleeding Diathes...	3 (.21%)
Embolism And Thrombosis	3 (.21%)
Fetal Complications	3 (.21%)
Miscellaneous And Site Unspecified ...	3 (.21%)
Pericardial	3 (.21%)
Protein And Chemistry Analyses	3 (.21%)
Skin And Subcutaneous Tissue Disord...	3 (.21%)
Tissue	3 (.21%)
Water, Electrolyte And Mineral	3 (.21%)
Bone, Calcium, Magnesium And Phosph...	2 (.14%)
Cranial Nerve Disorders	2 (.14%)
Disturbances In Thinking	2 (.14%)
Diverticular	2 (.14%)
Fetal And Neonatal	2 (.14%)
Gastrointestinal Ulceration And Per...	2 (.14%)
Hematopoietic Neoplasms	2 (.14%)
Metabolic, Nutritional And Blood Ga...	2 (.14%)

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This graph shows the top categories of adverse events submitted to the FDA for Gentamicin Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gentamicin Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.