FENOFIBRATE

Fenofibrate Adverse Events Reported to the FDA Over Time

How are Fenofibrate adverse event reports trending over time?

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

Most Common Fenofibrate Adverse Events Reported to the FDA

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

Rhabdomyolysis	186 (2.74%)
Drug Interaction	174 (2.57%)
Renal Failure Acute	168 (2.48%)
Hepatic Function Abnormal	120 (1.77%)
Myalgia	110 (1.62%)
High Density Lipoprotein Decreased	108 (1.59%)
Blood Creatine Phosphokinase Increa...	107 (1.58%)
Alanine Aminotransferase Increased	95 (1.4%)
Aspartate Aminotransferase Increase...	89 (1.31%)
Liver Disorder	89 (1.31%)
Renal Failure	71 (1.05%)
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Completed Suicide	70 (1.03%)
Gamma-glutamyltransferase Increased	61 (.9%)
Blood Creatinine Increased	60 (.89%)
Pyrexia	58 (.86%)
Jaundice	53 (.78%)
Renal Impairment	53 (.78%)
Pancreatitis Acute	49 (.72%)
Liver Function Test Abnormal	48 (.71%)
Arthralgia	46 (.68%)
Malaise	42 (.62%)
Asthenia	40 (.59%)
Fatigue	40 (.59%)
Hepatitis	40 (.59%)
International Normalised Ratio Incr...	40 (.59%)
Headache	38 (.56%)
Blood Triglycerides Increased	37 (.55%)
Dyspnoea	37 (.55%)
Pain	37 (.55%)
Anaemia	36 (.53%)
Vomiting	36 (.53%)
Nausea	35 (.52%)
Cytolytic Hepatitis	33 (.49%)
Pain In Extremity	33 (.49%)
Accidental Exposure	32 (.47%)
Weight Decreased	32 (.47%)
Muscle Spasms	31 (.46%)
Rash	31 (.46%)
Pruritus	29 (.43%)
Abdominal Pain	28 (.41%)
Fall	28 (.41%)
Muscular Weakness	28 (.41%)
Blood Lactate Dehydrogenase Increas...	27 (.4%)
Diarrhoea	27 (.4%)
Drug Ineffective	27 (.4%)
Hypertension	27 (.4%)
Hepatic Failure	26 (.38%)
Somnolence	26 (.38%)
Toxic Epidermal Necrolysis	26 (.38%)
Chest Pain	25 (.37%)
Cholestasis	25 (.37%)
Gait Disturbance	25 (.37%)
Haematoma	25 (.37%)
Metabolic Acidosis	25 (.37%)
Myopathy	25 (.37%)
Oedema Peripheral	25 (.37%)
Transaminases Increased	24 (.35%)
General Physical Health Deteriorati...	23 (.34%)
Thrombocytopenia	23 (.34%)
Cardiac Arrest	22 (.32%)
Drug Eruption	22 (.32%)
Erythema Multiforme	22 (.32%)
Haematuria	22 (.32%)
Hyponatraemia	22 (.32%)
Overdose	21 (.31%)
Pancreatitis	21 (.31%)
Abdominal Pain Upper	20 (.3%)
Blood Urea Increased	20 (.3%)
Sepsis	20 (.3%)
Blood Bilirubin Increased	19 (.28%)
Cholelithiasis	19 (.28%)
Dizziness	19 (.28%)
Gastrointestinal Haemorrhage	19 (.28%)
Hepatic Steatosis	19 (.28%)
Hypertriglyceridaemia	19 (.28%)
Back Pain	18 (.27%)
Constipation	18 (.27%)
Melaena	18 (.27%)
Pulmonary Embolism	18 (.27%)
Cardiac Disorder	17 (.25%)
Confusional State	17 (.25%)
Hyperkalaemia	17 (.25%)
Neutrophil Count Decreased	17 (.25%)
White Blood Cell Count Decreased	17 (.25%)
Dehydration	16 (.24%)
Drug Rash With Eosinophilia And Sys...	16 (.24%)
Haemoglobin Decreased	16 (.24%)
Inflammation	16 (.24%)
Influenza Like Illness	16 (.24%)
Myocardial Infarction	16 (.24%)
Purpura	16 (.24%)
Tremor	16 (.24%)
Anorexia	15 (.22%)
Cardiac Failure	15 (.22%)
Blood Alkaline Phosphatase Increase...	14 (.21%)
Hypoglycaemia	14 (.21%)
Hypothyroidism	14 (.21%)
Leukocytoclastic Vasculitis	14 (.21%)
Multi-organ Failure	14 (.21%)
Myositis	14 (.21%)
Agranulocytosis	13 (.19%)

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

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

Hepatic And Hepatobiliary	464 (6.85%)
Muscle	418 (6.17%)
Hepatobiliary	355 (5.24%)
Renal Disorders	331 (4.88%)
Epidermal And Dermal Conditions	294 (4.34%)
Therapeutic And Nontherapeutic Effe...	216 (3.19%)
Hematology Investigations	179 (2.64%)
Lipid Analyses	175 (2.58%)
Gastrointestinal Signs	174 (2.57%)
Neurological	164 (2.42%)
Enzyme	157 (2.32%)
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Respiratory	116 (1.71%)
Renal And Urinary Tract Investigati...	113 (1.67%)
Infections - Pathogen Unspecified	108 (1.59%)
Joint	90 (1.33%)
Cardiac Arrhythmias	89 (1.31%)
Musculoskeletal And Connective Tiss...	84 (1.24%)
Exocrine Pancreas Conditions	81 (1.2%)
Medication Errors	76 (1.12%)
Electrolyte And Fluid Balance Condi...	75 (1.11%)
Urinary Tract Signs	73 (1.08%)
Suicidal And Self-injurious Behavio...	72 (1.06%)
Skin Vascular Abnormalities	71 (1.05%)
Anemias Nonhemolytic And Marrow Dep...	69 (1.02%)
Injuries	69 (1.02%)
White Blood Cell	66 (.97%)
Body Temperature Conditions	58 (.86%)
Physical Examination Topics	54 (.8%)
Gastrointestinal Motility And Defec...	53 (.78%)
Gastrointestinal Hemorrhages	52 (.77%)
Movement Disorders	50 (.74%)
Lower Respiratory Tract Disorders	48 (.71%)
Cardiac And Vascular Investigations	46 (.68%)
Coronary Artery	44 (.65%)
Glucose Metabolism Disorders	44 (.65%)
Decreased And Nonspecific Blood Pre...	43 (.63%)
Bacterial Infectious	40 (.59%)
Headaches	40 (.59%)
Water, Electrolyte And Mineral	40 (.59%)
Metabolic, Nutritional And Blood Ga...	39 (.58%)
Acid-base	38 (.56%)
Central Nervous System Vascular	38 (.56%)
Peripheral Neuropathies	36 (.53%)
Viral Infectious	36 (.53%)
Appetite And General Nutritional	32 (.47%)
Gallbladder	32 (.47%)
Myocardial	31 (.46%)
Vascular	31 (.46%)
Vascular Hemorrhagic	31 (.46%)
Immunology And Allergy	30 (.44%)
Thyroid Gland	29 (.43%)
Cardiac Disorder Signs	28 (.41%)
Lipid Metabolism	28 (.41%)
Vascular Hypertensive	28 (.41%)
Vision	28 (.41%)
Platelet	27 (.4%)
Allergic Conditions	24 (.35%)
Spinal Cord And Nerve Root	24 (.35%)
Chemical Injury And Poisoning	23 (.34%)
Angiedema And Urticaria	22 (.32%)
Arteriosclerosis, Stenosis, Vascula...	22 (.32%)
Heart Failures	21 (.31%)
Hematological And Lymphoid Tissue T...	21 (.31%)
Pulmonary Vascular	21 (.31%)
Deliria	19 (.28%)
Depressed Mood Disorders	18 (.27%)
Fatal Outcomes	18 (.27%)
Procedural And Device Related Injur...	18 (.27%)
Protein And Chemistry Analyses	18 (.27%)
Renal And Urinary Tract Neoplasms M...	18 (.27%)
Seizures	18 (.27%)
Embolism And Thrombosis	17 (.25%)
Gastrointestinal Inflammatory Condi...	17 (.25%)
Gastrointestinal Ulceration And Per...	17 (.25%)
Lifestyle Issues	17 (.25%)
Nephropathies	17 (.25%)
Mental Impairment	16 (.24%)
Tendon, Ligament And Cartilage	16 (.24%)
Toxicology And Therapeutic Drug Mon...	15 (.22%)
Cardiac Valve	14 (.21%)
Neuromuscular	14 (.21%)
Peritoneal And Retroperitoneal Cond...	14 (.21%)
Gastrointestinal	13 (.19%)
Musculoskeletal And Soft Tissue Inv...	13 (.19%)
Ocular Neuromuscular	13 (.19%)
Sleep Disorders	13 (.19%)
Upper Respiratory Tract Disorders	13 (.19%)
Ocular Infections, Irritations And ...	12 (.18%)
Skin Appendage Conditions	12 (.18%)
Anxiety Disorders	11 (.16%)
Tongue Conditions	11 (.16%)
Endocrine Investigations	10 (.15%)
Oral Soft Tissue Conditions	10 (.15%)
Psychiatric	10 (.15%)
Urolithiases	10 (.15%)
Coagulopathies And Bleeding Diathes...	9 (.13%)
Connective Tissue Disorders	9 (.13%)
Disturbances In Thinking	9 (.13%)
Neurological Disorders Congenital	9 (.13%)
Therapeutic Procedures And Supporti...	9 (.13%)
Encephalopathies	8 (.12%)

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