KETOCONAZOLE

Ketoconazole Adverse Events Reported to the FDA Over Time

How are Ketoconazole adverse event reports trending over time?

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

Most Common Ketoconazole Adverse Events Reported to the FDA

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

Drug Interaction	83 (3.4%)
Rhabdomyolysis	68 (2.79%)
Off Label Use	48 (1.97%)
Nausea	39 (1.6%)
Renal Failure Acute	35 (1.44%)
Vomiting	33 (1.35%)
Asthenia	31 (1.27%)
Dehydration	31 (1.27%)
Fatigue	31 (1.27%)
Rash	29 (1.19%)
Drug Ineffective	27 (1.11%)
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Diarrhoea	25 (1.03%)
Pruritus	25 (1.03%)
Prostatic Specific Antigen Increase...	21 (.86%)
Aspartate Aminotransferase Increase...	20 (.82%)
Dizziness	20 (.82%)
Renal Failure	20 (.82%)
Alanine Aminotransferase Increased	19 (.78%)
Hepatotoxicity	19 (.78%)
Hepatitis	18 (.74%)
Malaise	18 (.74%)
Alopecia	17 (.7%)
Fall	17 (.7%)
Jaundice	16 (.66%)
Liver Disorder	15 (.62%)
Pyrexia	15 (.62%)
Erythema	14 (.57%)
Abdominal Pain	13 (.53%)
Confusional State	13 (.53%)
Myalgia	13 (.53%)
Drug Ineffective For Unapproved Ind...	12 (.49%)
Febrile Neutropenia	12 (.49%)
Hepatic Enzyme Increased	12 (.49%)
Pain	12 (.49%)
Thrombocytopenia	12 (.49%)
Condition Aggravated	11 (.45%)
Cough	11 (.45%)
Neutropenia	11 (.45%)
Urticaria	11 (.45%)
Anaemia	10 (.41%)
Back Pain	10 (.41%)
Deep Vein Thrombosis	10 (.41%)
Dyspnoea	10 (.41%)
Headache	10 (.41%)
Hepatic Failure	10 (.41%)
Hypotension	10 (.41%)
Liver Function Test Abnormal	10 (.41%)
Loss Of Consciousness	10 (.41%)
Blood Alkaline Phosphatase Increase...	9 (.37%)
Convulsion	9 (.37%)
Depression	9 (.37%)
Mental Status Changes	9 (.37%)
Mucosal Inflammation	9 (.37%)
Skin Exfoliation	9 (.37%)
Tremor	9 (.37%)
Weight Decreased	9 (.37%)
Atrioventricular Block Complete	8 (.33%)
Blister	8 (.33%)
Decreased Appetite	8 (.33%)
Disease Progression	8 (.33%)
Drug Hypersensitivity	8 (.33%)
Hepatitis Cholestatic	8 (.33%)
Hyperkalaemia	8 (.33%)
Hypokalaemia	8 (.33%)
Muscular Weakness	8 (.33%)
Neurotoxicity	8 (.33%)
Skin Burning Sensation	8 (.33%)
Suicidal Ideation	8 (.33%)
Swelling Face	8 (.33%)
Weight Increased	8 (.33%)
Blood Creatinine Increased	7 (.29%)
Cholestasis	7 (.29%)
Erectile Dysfunction	7 (.29%)
Fluid Retention	7 (.29%)
Hepatic Necrosis	7 (.29%)
Hypersensitivity	7 (.29%)
Hypoglycaemia	7 (.29%)
Oedema Peripheral	7 (.29%)
Pulmonary Embolism	7 (.29%)
Renal Impairment	7 (.29%)
Septic Shock	7 (.29%)
Atrial Fibrillation	6 (.25%)
Cardiac Failure Congestive	6 (.25%)
Constipation	6 (.25%)
Dermatitis	6 (.25%)
Dry Skin	6 (.25%)
Electrocardiogram Qt Prolonged	6 (.25%)
Haemoglobin Decreased	6 (.25%)
Hepatitis Acute	6 (.25%)
Hydronephrosis	6 (.25%)
Hypocalcaemia	6 (.25%)
Hypoxia	6 (.25%)
Ileus	6 (.25%)
Leukopenia	6 (.25%)
Neutrophil Count Decreased	6 (.25%)
Pain In Extremity	6 (.25%)
Prostate Cancer	6 (.25%)
Rash Erythematous	6 (.25%)
Rash Pruritic	6 (.25%)
White Blood Cell Count Decreased	6 (.25%)
Abdominal Distension	5 (.21%)

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

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

Epidermal And Dermal Conditions	174 (7.14%)
Therapeutic And Nontherapeutic Effe...	141 (5.78%)
Hepatic And Hepatobiliary	127 (5.21%)
Muscle	103 (4.22%)
Gastrointestinal Signs	96 (3.94%)
Neurological	82 (3.36%)
Hepatobiliary	75 (3.08%)
Renal Disorders	70 (2.87%)
Electrolyte And Fluid Balance Condi...	65 (2.67%)
Therapeutic Procedures And Supporti...	53 (2.17%)
Hematology Investigations	51 (2.09%)
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Cardiac Arrhythmias	49 (2.01%)
Respiratory	49 (2.01%)
Infections - Pathogen Unspecified	46 (1.89%)
Gastrointestinal Motility And Defec...	37 (1.52%)
White Blood Cell	35 (1.44%)
Skin Appendage Conditions	30 (1.23%)
Allergic Conditions	29 (1.19%)
Bacterial Infectious	27 (1.11%)
Injuries	27 (1.11%)
Medication Errors	26 (1.07%)
Immunology And Allergy	23 (.94%)
Physical Examination Topics	23 (.94%)
Anemias Nonhemolytic And Marrow Dep...	20 (.82%)
Musculoskeletal And Connective Tiss...	20 (.82%)
Enzyme	19 (.78%)
Cardiac And Vascular Investigations	18 (.74%)
Decreased And Nonspecific Blood Pre...	18 (.74%)
Lower Respiratory Tract Disorders	18 (.74%)
Body Temperature Conditions	17 (.7%)
Glucose Metabolism Disorders	17 (.7%)
Fungal Infectious	16 (.66%)
Urinary Tract Signs	16 (.66%)
Psychiatric	15 (.62%)
Deliria	14 (.57%)
Renal And Urinary Tract Investigati...	14 (.57%)
Angiedema And Urticaria	13 (.53%)
Depressed Mood Disorders	13 (.53%)
Oral Soft Tissue Conditions	13 (.53%)
Anxiety Disorders	12 (.49%)
Bone, Calcium, Magnesium And Phosph...	12 (.49%)
Embolism And Thrombosis	12 (.49%)
Gastrointestinal Stenosis And Obstr...	12 (.49%)
Joint	12 (.49%)
Platelet	12 (.49%)
Suicidal And Self-injurious Behavio...	12 (.49%)
Appetite And General Nutritional	11 (.45%)
Cardiac Disorder Signs	11 (.45%)
Microbiology And Serology	11 (.45%)
Movement Disorders	11 (.45%)
Peripheral Neuropathies	11 (.45%)
Endocrine Investigations	10 (.41%)
Headaches	10 (.41%)
Heart Failures	10 (.41%)
Miscellaneous And Site Unspecified ...	10 (.41%)
Seizures	10 (.41%)
Bone Disorders	9 (.37%)
Metabolic, Nutritional And Blood Ga...	9 (.37%)
Reproductive Neoplasms Male Maligna...	9 (.37%)
Skin And Subcutaneous Tissue	9 (.37%)
Adrenal Gland	8 (.33%)
Coronary Artery	8 (.33%)
Lifestyle Issues	8 (.33%)
Pulmonary Vascular	8 (.33%)
Vision	8 (.33%)
Water, Electrolyte And Mineral	8 (.33%)
Acid-base	7 (.29%)
Bone And Joint Injuries	7 (.29%)
Chemical Injury And Poisoning	7 (.29%)
Mental Impairment	7 (.29%)
Sexual Function And Fertility	7 (.29%)
Vulvovaginal Disorders	7 (.29%)
Arteriosclerosis, Stenosis, Vascula...	6 (.25%)
Aural	6 (.25%)
Fatal Outcomes	6 (.25%)
Administration Site Reactions	5 (.21%)
Anterior Eye Structural Change, Dep...	5 (.21%)
Diverticular	5 (.21%)
Eye	5 (.21%)
Hearing	5 (.21%)
Increased Intracranial Pressure And...	5 (.21%)
Investigations, Imaging And Histopa...	5 (.21%)
Nephropathies	5 (.21%)
Peritoneal And Retroperitoneal Cond...	5 (.21%)
Skin Vascular Abnormalities	5 (.21%)
Toxicology And Therapeutic Drug Mon...	5 (.21%)
Vascular Hypertensive	5 (.21%)
Abortions And Stillbirth	4 (.16%)
Bronchial Disorders	4 (.16%)
Cardiac And Vascular Disorders Cong...	4 (.16%)
Coagulopathies And Bleeding Diathes...	4 (.16%)
Gastrointestinal Ulceration And Per...	4 (.16%)
Gastrointestinal Vascular Condition...	4 (.16%)
Hypothalamus And Pituitary Gland	4 (.16%)
Injuries By Physical Agents	4 (.16%)
Musculoskeletal And Connective Tiss...	4 (.16%)
Myocardial	4 (.16%)
Neonatal And Perinatal Conditions	4 (.16%)
Nervous System Neoplasms Benign	4 (.16%)
Ocular Infections, Irritations And ...	4 (.16%)
Pleural	4 (.16%)

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