GENTAMICIN

Gentamicin Adverse Events Reported to the FDA Over Time

How are Gentamicin adverse event reports trending over time?

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

Most Common Gentamicin Adverse Events Reported to the FDA

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

Renal Failure Acute	273 (4.11%)
Renal Failure	94 (1.41%)
Pyrexia	93 (1.4%)
Blood Creatinine Increased	82 (1.23%)
Renal Tubular Necrosis	69 (1.04%)
Dizziness	64 (.96%)
Drug Interaction	63 (.95%)
Balance Disorder	60 (.9%)
Drug Rash With Eosinophilia And Sys...	56 (.84%)
Toxic Epidermal Necrolysis	55 (.83%)
Condition Aggravated	48 (.72%)
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Metabolic Acidosis	46 (.69%)
Rash	43 (.65%)
Drug Ineffective	37 (.56%)
Myocardial Infarction	37 (.56%)
Nephropathy Toxic	37 (.56%)
Anaphylactic Reaction	36 (.54%)
Drug Exposure During Pregnancy	36 (.54%)
Multi-organ Failure	36 (.54%)
Hypotension	35 (.53%)
Vestibular Disorder	34 (.51%)
Drug Toxicity	33 (.5%)
Gait Disturbance	32 (.48%)
Disorientation	31 (.47%)
Neutropenia	31 (.47%)
Sepsis	31 (.47%)
Nausea	30 (.45%)
Renal Impairment	30 (.45%)
Septic Shock	30 (.45%)
General Physical Health Deteriorati...	29 (.44%)
Ototoxicity	29 (.44%)
Haemodialysis	28 (.42%)
Tinnitus	28 (.42%)
Vomiting	28 (.42%)
Dialysis	27 (.41%)
Pruritus	27 (.41%)
Dyspnoea	26 (.39%)
Thrombocytopenia	26 (.39%)
Brain Oedema	25 (.38%)
Aphasia	24 (.36%)
Eosinophilia	24 (.36%)
Face Oedema	24 (.36%)
Vision Blurred	24 (.36%)
Erythema	23 (.35%)
Staphylococcal Infection	23 (.35%)
Drug Hypersensitivity	22 (.33%)
Encephalopathy	22 (.33%)
Endocarditis	22 (.33%)
Hypotonia	22 (.33%)
Leukopenia	22 (.33%)
Status Epilepticus	22 (.33%)
Aspergillosis	21 (.32%)
Rash Maculo-papular	21 (.32%)
Tubulointerstitial Nephritis	21 (.32%)
Anaemia	20 (.3%)
Cognitive Disorder	20 (.3%)
Diarrhoea	20 (.3%)
Drug Level Increased	20 (.3%)
Dystonia	20 (.3%)
Generalised Oedema	20 (.3%)
Hypokalaemia	20 (.3%)
Premature Baby	20 (.3%)
Vertigo	20 (.3%)
Convulsion	19 (.29%)
Disseminated Intravascular Coagulat...	19 (.29%)
Learning Disorder	19 (.29%)
Medication Error	19 (.29%)
Movement Disorder	19 (.29%)
Somnolence	19 (.29%)
Toxic Skin Eruption	19 (.29%)
Akinesia	18 (.27%)
Deafness	18 (.27%)
Fall	18 (.27%)
Hypersensitivity	18 (.27%)
Respiratory Distress	18 (.27%)
Treatment Failure	18 (.27%)
Anuria	17 (.26%)
Application Site Erythema	17 (.26%)
Blood Urea Increased	17 (.26%)
Cholestasis	17 (.26%)
Confusional State	17 (.26%)
Dehydration	17 (.26%)
Haematoma	17 (.26%)
Overdose	17 (.26%)
Pain	17 (.26%)
Urticaria	17 (.26%)
Abdominal Pain	16 (.24%)
Alanine Aminotransferase Increased	16 (.24%)
Cytomegalovirus Infection	16 (.24%)
Deafness Neurosensory	16 (.24%)
Eyelid Oedema	16 (.24%)
Haemoglobin Decreased	16 (.24%)
Hypoacusis	16 (.24%)
Hypomagnesaemia	16 (.24%)
International Normalised Ratio Incr...	16 (.24%)
Neurotoxicity	16 (.24%)
Rash Pruritic	16 (.24%)
Stevens-johnson Syndrome	16 (.24%)
Hypocalcaemia	15 (.23%)
Lung Disorder	15 (.23%)
Arthralgia	14 (.21%)

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This graph shows the top adverse events submitted to the FDA for Gentamicin, 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 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

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

Renal Disorders	524 (7.88%)
Epidermal And Dermal Conditions	486 (7.31%)
Neurological	320 (4.81%)
Infections - Pathogen Unspecified	280 (4.21%)
Bacterial Infectious	221 (3.32%)
Therapeutic And Nontherapeutic Effe...	137 (2.06%)
Renal And Urinary Tract Investigati...	128 (1.93%)
Hematology Investigations	119 (1.79%)
Respiratory	116 (1.74%)
White Blood Cell	110 (1.65%)
Hepatic And Hepatobiliary	108 (1.62%)
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Body Temperature Conditions	100 (1.5%)
Gastrointestinal Signs	98 (1.47%)
Inner Ear And Viiith Cranial Nerve	96 (1.44%)
Nephropathies	91 (1.37%)
Ocular Infections, Irritations And ...	91 (1.37%)
Administration Site Reactions	88 (1.32%)
Movement Disorders	87 (1.31%)
Allergic Conditions	86 (1.29%)
Chemical Injury And Poisoning	82 (1.23%)
Injuries	79 (1.19%)
Medication Errors	78 (1.17%)
Electrolyte And Fluid Balance Condi...	75 (1.13%)
Vision	68 (1.02%)
Acid-base	66 (.99%)
Hepatobiliary	66 (.99%)
Hearing	65 (.98%)
Fungal Infectious	63 (.95%)
Urinary Tract Signs	59 (.89%)
Seizures	58 (.87%)
Hematological And Lymphoid Tissue T...	57 (.86%)
Cardiac Arrhythmias	56 (.84%)
Lifestyle Issues	54 (.81%)
Deliria	52 (.78%)
Bone, Calcium, Magnesium And Phosph...	51 (.77%)
Cardiac And Vascular Investigations	50 (.75%)
Anemias Nonhemolytic And Marrow Dep...	49 (.74%)
Decreased And Nonspecific Blood Pre...	49 (.74%)
Muscle	48 (.72%)
Eye	47 (.71%)
Coronary Artery	43 (.65%)
Aural	42 (.63%)
Lower Respiratory Tract Disorders	40 (.6%)
Mental Impairment	39 (.59%)
Viral Infectious	39 (.59%)
Gastrointestinal Motility And Defec...	38 (.57%)
Platelet	35 (.53%)
Coagulopathies And Bleeding Diathes...	32 (.48%)
Increased Intracranial Pressure And...	31 (.47%)
Angiedema And Urticaria	30 (.45%)
Musculoskeletal And Connective Tiss...	29 (.44%)
Neonatal And Perinatal Conditions	29 (.44%)
Neuromuscular	29 (.44%)
Physical Examination Topics	28 (.42%)
Toxicology And Therapeutic Drug Mon...	28 (.42%)
Vascular Hemorrhagic	28 (.42%)
Water, Electrolyte And Mineral	28 (.42%)
Central Nervous System Vascular	27 (.41%)
Procedural And Device Related Injur...	27 (.41%)
Anterior Eye Structural Change, Dep...	26 (.39%)
Retina, Choroid And Vitreous Hemorr...	26 (.39%)
Appetite And General Nutritional	25 (.38%)
Encephalopathies	25 (.38%)
Microbiology And Serology	25 (.38%)
Anxiety Disorders	24 (.36%)
Bone And Joint Therapeutic Procedur...	24 (.36%)
Joint	24 (.36%)
Gastrointestinal Hemorrhages	23 (.35%)
Cardiac Valve	22 (.33%)
Protein And Chemistry Analyses	21 (.32%)
Upper Respiratory Tract Disorders	21 (.32%)
Cognitive And Attention Disorders	20 (.3%)
Structural Brain	20 (.3%)
Immune	18 (.27%)
Metabolic, Nutritional And Blood Ga...	18 (.27%)
Enzyme	17 (.26%)
Heart Failures	17 (.26%)
Obstetric And Gynecological Therape...	17 (.26%)
Skin Vascular Abnormalities	17 (.26%)
Fatal Outcomes	16 (.24%)
Gastrointestinal Inflammatory Condi...	16 (.24%)
Gastrointestinal Ulceration And Per...	16 (.24%)
Vascular	16 (.24%)
Protein And Amino Acid Metabolism	15 (.23%)
Embolism And Thrombosis	14 (.21%)
Myocardial	14 (.21%)
Neurological, Special Senses And Ps...	14 (.21%)
Ocular Neuromuscular	14 (.21%)
Pleural	14 (.21%)
Arteriosclerosis, Stenosis, Vascula...	13 (.2%)
Oral Soft Tissue Conditions	13 (.2%)
Exocrine Pancreas Conditions	12 (.18%)
Tissue	12 (.18%)
Tongue Conditions	12 (.18%)
Vascular Hypertensive	12 (.18%)
Bronchial Disorders	11 (.17%)
Disturbances In Thinking	11 (.17%)
Neonatal Respiratory	11 (.17%)
Ocular Sensory Symptoms	11 (.17%)
Ocular Structural Change, Deposit A...	11 (.17%)
Peripheral Neuropathies	11 (.17%)

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This graph shows the top categories of adverse events submitted to the FDA for Gentamicin, 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 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.