FLUCONAZOLE

Fluconazole Adverse Events Reported to the FDA Over Time

How are Fluconazole adverse event reports trending over time?

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

Most Common Fluconazole Adverse Events Reported to the FDA

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

Drug Interaction	496 (3.32%)
Pyrexia	221 (1.48%)
Renal Failure Acute	198 (1.32%)
Drug Ineffective	151 (1.01%)
Rhabdomyolysis	149 (1%)
Nausea	124 (.83%)
Vomiting	112 (.75%)
Thrombocytopenia	104 (.7%)
Torsade De Pointes	101 (.68%)
Headache	99 (.66%)
Septic Shock	92 (.62%)
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Dyspnoea	89 (.59%)
Toxic Epidermal Necrolysis	89 (.59%)
Renal Failure	87 (.58%)
International Normalised Ratio Incr...	84 (.56%)
Neutropenia	84 (.56%)
Candidiasis	81 (.54%)
Electrocardiogram Qt Prolonged	81 (.54%)
Loss Of Consciousness	81 (.54%)
Rash	80 (.53%)
Multi-organ Failure	79 (.53%)
Pruritus	78 (.52%)
Dehydration	77 (.51%)
Dizziness	74 (.49%)
Stevens-johnson Syndrome	74 (.49%)
Diarrhoea	72 (.48%)
Renal Impairment	72 (.48%)
Alanine Aminotransferase Increased	71 (.47%)
Pancytopenia	70 (.47%)
Sepsis	69 (.46%)
Haemoglobin Decreased	68 (.45%)
Hepatotoxicity	68 (.45%)
Malaise	68 (.45%)
Drug Rash With Eosinophilia And Sys...	66 (.44%)
Liver Function Test Abnormal	66 (.44%)
Respiratory Failure	66 (.44%)
Atrial Fibrillation	64 (.43%)
Hypotension	64 (.43%)
Drug Level Increased	62 (.41%)
Blood Creatinine Increased	61 (.41%)
Death	60 (.4%)
Febrile Neutropenia	60 (.4%)
Metabolic Acidosis	58 (.39%)
Drug Eruption	56 (.37%)
Erythema	56 (.37%)
Immune Reconstitution Syndrome	56 (.37%)
Asthenia	55 (.37%)
Fatigue	55 (.37%)
Hypokalaemia	55 (.37%)
White Blood Cell Count Decreased	55 (.37%)
Pneumonia	54 (.36%)
Blood Alkaline Phosphatase Increase...	52 (.35%)
Drug Resistance	52 (.35%)
Gamma-glutamyltransferase Increased	52 (.35%)
Blood Bilirubin Increased	51 (.34%)
Drug Toxicity	51 (.34%)
Aspartate Aminotransferase Increase...	50 (.33%)
Fungal Infection	50 (.33%)
Leukopenia	50 (.33%)
General Physical Health Deteriorati...	48 (.32%)
Pain	48 (.32%)
Urticaria	48 (.32%)
Gastrointestinal Haemorrhage	47 (.31%)
Hypoglycaemia	47 (.31%)
Platelet Count Decreased	46 (.31%)
Confusional State	45 (.3%)
Dysphagia	44 (.29%)
Drug Exposure During Pregnancy	43 (.29%)
Mental Status Changes	43 (.29%)
Anaemia	42 (.28%)
Jaundice	42 (.28%)
Acute Generalised Exanthematous Pus...	41 (.27%)
Grand Mal Convulsion	41 (.27%)
Haemorrhage	40 (.27%)
Idiosyncratic Drug Reaction	40 (.27%)
Condition Aggravated	39 (.26%)
Agranulocytosis	38 (.25%)
Hyponatraemia	38 (.25%)
Meningitis Cryptococcal	38 (.25%)
Rash Maculo-papular	38 (.25%)
Alopecia	37 (.25%)
Blister	37 (.25%)
Convulsion	37 (.25%)
Drug Hypersensitivity	37 (.25%)
Muscular Weakness	37 (.25%)
Rash Erythematous	37 (.25%)
Abdominal Pain	36 (.24%)
Hepatic Failure	36 (.24%)
Tuberculosis	36 (.24%)
Cardiac Arrest	35 (.23%)
Oral Candidiasis	35 (.23%)
Acute Hepatic Failure	34 (.23%)
Arrhythmia	34 (.23%)
Coagulopathy	34 (.23%)
Cytomegalovirus Infection	34 (.23%)
Infection	34 (.23%)
Vision Blurred	34 (.23%)
Weight Decreased	34 (.23%)
Back Pain	33 (.22%)
Cytolytic Hepatitis	33 (.22%)
Oedema Peripheral	33 (.22%)

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

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

Epidermal And Dermal Conditions	1036 (6.93%)
Therapeutic And Nontherapeutic Effe...	863 (5.77%)
Neurological	572 (3.82%)
Infections - Pathogen Unspecified	551 (3.68%)
Fungal Infectious	526 (3.52%)
Cardiac Arrhythmias	459 (3.07%)
Hepatic And Hepatobiliary	458 (3.06%)
Renal Disorders	419 (2.8%)
Gastrointestinal Signs	396 (2.65%)
Hematology Investigations	374 (2.5%)
Respiratory	373 (2.49%)
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Hepatobiliary	357 (2.39%)
White Blood Cell	283 (1.89%)
Muscle	245 (1.64%)
Bacterial Infectious	238 (1.59%)
Body Temperature Conditions	229 (1.53%)
Electrolyte And Fluid Balance Condi...	213 (1.42%)
Cardiac And Vascular Investigations	171 (1.14%)
Anemias Nonhemolytic And Marrow Dep...	161 (1.08%)
Oral Soft Tissue Conditions	155 (1.04%)
Injuries	133 (.89%)
Gastrointestinal Motility And Defec...	125 (.84%)
Toxicology And Therapeutic Drug Mon...	124 (.83%)
Platelet	120 (.8%)
Lower Respiratory Tract Disorders	117 (.78%)
Chemical Injury And Poisoning	115 (.77%)
Renal And Urinary Tract Investigati...	113 (.76%)
Seizures	109 (.73%)
Headaches	108 (.72%)
Viral Infectious	106 (.71%)
Musculoskeletal And Connective Tiss...	104 (.7%)
Enzyme	103 (.69%)
Vision	100 (.67%)
Water, Electrolyte And Mineral	100 (.67%)
Central Nervous System Vascular	97 (.65%)
Decreased And Nonspecific Blood Pre...	97 (.65%)
Gastrointestinal Hemorrhages	94 (.63%)
Deliria	91 (.61%)
Physical Examination Topics	91 (.61%)
Medication Errors	90 (.6%)
Glucose Metabolism Disorders	89 (.59%)
Allergic Conditions	84 (.56%)
Fatal Outcomes	83 (.55%)
Movement Disorders	83 (.55%)
Vulvovaginal Disorders	78 (.52%)
Ocular Neuromuscular	74 (.49%)
Appetite And General Nutritional	73 (.49%)
Acid-base	69 (.46%)
Immunodeficiency Syndromes	69 (.46%)
Microbiology And Serology	68 (.45%)
Ocular Infections, Irritations And ...	68 (.45%)
Anxiety Disorders	65 (.43%)
Angiedema And Urticaria	64 (.43%)
Skin Appendage Conditions	63 (.42%)
Urinary Tract Signs	63 (.42%)
Metabolic, Nutritional And Blood Ga...	62 (.41%)
Hematological And Lymphoid Tissue T...	61 (.41%)
Psychiatric	59 (.39%)
Immune	58 (.39%)
Procedural And Device Related Injur...	58 (.39%)
Upper Respiratory Tract Disorders	57 (.38%)
Lifestyle Issues	55 (.37%)
Bone, Calcium, Magnesium And Phosph...	53 (.35%)
Musculoskeletal And Connective Tiss...	51 (.34%)
Gastrointestinal Inflammatory Condi...	50 (.33%)
Neuromuscular	50 (.33%)
Mycobacterial Infectious	48 (.32%)
Peritoneal And Retroperitoneal Cond...	48 (.32%)
Gastrointestinal Ulceration And Per...	47 (.31%)
Vascular Hemorrhagic	47 (.31%)
Encephalopathies	46 (.31%)
Protein And Chemistry Analyses	46 (.31%)
Joint	45 (.3%)
Skin Vascular Abnormalities	44 (.29%)
Nephropathies	43 (.29%)
Coagulopathies And Bleeding Diathes...	41 (.27%)
Depressed Mood Disorders	40 (.27%)
Tongue Conditions	38 (.25%)
Adrenal Gland	37 (.25%)
Vascular	36 (.24%)
Cardiac Disorder Signs	35 (.23%)
Congenital And Hereditary	35 (.23%)
Pleural	34 (.23%)
Hearing	33 (.22%)
Exocrine Pancreas Conditions	32 (.21%)
Bronchial Disorders	30 (.2%)
Myocardial	30 (.2%)
Neurological, Special Senses And Ps...	30 (.2%)
Hemolyses And Related Conditions	29 (.19%)
Embolism And Thrombosis	28 (.19%)
Increased Intracranial Pressure And...	28 (.19%)
Mental Impairment	28 (.19%)
Abortions And Stillbirth	27 (.18%)
Spleen, Lymphatic And Reticulendoth...	27 (.18%)
Heart Failures	26 (.17%)
Arteriosclerosis, Stenosis, Vascula...	25 (.17%)
Disturbances In Thinking	25 (.17%)
Peripheral Neuropathies	25 (.17%)
Ocular Structural Change, Deposit A...	24 (.16%)
Eye	23 (.15%)
Investigations, Imaging And Histopa...	23 (.15%)

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