GEMFIBROZIL

Gemfibrozil Adverse Events Reported to the FDA Over Time

How are Gemfibrozil adverse event reports trending over time?

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

Most Common Gemfibrozil Adverse Events Reported to the FDA

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

Rhabdomyolysis	248 (7.68%)
Renal Failure Acute	122 (3.78%)
Myalgia	96 (2.97%)
Drug Interaction	93 (2.88%)
Completed Suicide	78 (2.41%)
Blood Creatine Phosphokinase Increa...	75 (2.32%)
Asthenia	71 (2.2%)
Nausea	47 (1.45%)
Blood Creatinine Increased	34 (1.05%)
Muscular Weakness	34 (1.05%)
Aspartate Aminotransferase Increase...	33 (1.02%)
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Alanine Aminotransferase Increased	32 (.99%)
Fatigue	32 (.99%)
Vomiting	32 (.99%)
Dizziness	30 (.93%)
Confusional State	26 (.8%)
Gait Disturbance	26 (.8%)
Arthralgia	25 (.77%)
Cardiac Arrest	24 (.74%)
Abdominal Pain	23 (.71%)
Hepatic Enzyme Increased	23 (.71%)
Muscle Spasms	23 (.71%)
Myopathy	23 (.71%)
Pain In Extremity	23 (.71%)
Renal Failure	23 (.71%)
Blood Triglycerides Increased	22 (.68%)
Diarrhoea	22 (.68%)
Pain	22 (.68%)
Fall	21 (.65%)
Respiratory Arrest	21 (.65%)
Loss Of Consciousness	20 (.62%)
Cardio-respiratory Arrest	18 (.56%)
Chromaturia	18 (.56%)
Haemodialysis	18 (.56%)
Medication Error	18 (.56%)
Pruritus	18 (.56%)
Liver Function Test Abnormal	16 (.5%)
Malaise	16 (.5%)
Myositis	16 (.5%)
Rash	16 (.5%)
Vision Blurred	16 (.5%)
Headache	15 (.46%)
Death	14 (.43%)
Dehydration	14 (.43%)
Drug Toxicity	14 (.43%)
Hypotension	14 (.43%)
Abasia	13 (.4%)
Back Pain	13 (.4%)
Blood Cholesterol Increased	13 (.4%)
Chest Pain	13 (.4%)
Dyspnoea	13 (.4%)
Hyperkalaemia	13 (.4%)
Renal Impairment	13 (.4%)
Convulsion	12 (.37%)
Dysstasia	12 (.37%)
International Normalised Ratio Incr...	12 (.37%)
Decreased Appetite	11 (.34%)
Drug Dispensing Error	11 (.34%)
Insomnia	11 (.34%)
Paraesthesia	11 (.34%)
Abdominal Pain Upper	10 (.31%)
Blood Urea Increased	10 (.31%)
Diabetes Mellitus	10 (.31%)
Dialysis	10 (.31%)
Anaemia	9 (.28%)
Anxiety	9 (.28%)
Condition Aggravated	9 (.28%)
Constipation	9 (.28%)
Haematuria	9 (.28%)
Hepatitis	9 (.28%)
Metabolic Acidosis	9 (.28%)
Oedema Peripheral	9 (.28%)
Overdose	9 (.28%)
Pyrexia	9 (.28%)
Depression	8 (.25%)
Drug Ineffective	8 (.25%)
Musculoskeletal Stiffness	8 (.25%)
Pancreatitis	8 (.25%)
Agitation	7 (.22%)
Blood Alkaline Phosphatase Increase...	7 (.22%)
Circumstance Or Information Capable...	7 (.22%)
Coronary Artery Occlusion	7 (.22%)
Drug Hypersensitivity	7 (.22%)
Dysphagia	7 (.22%)
Hepatic Function Abnormal	7 (.22%)
Hypoaesthesia	7 (.22%)
Intentional Drug Misuse	7 (.22%)
Mood Swings	7 (.22%)
Myocardial Infarction	7 (.22%)
Poisoning	7 (.22%)
Suicidal Ideation	7 (.22%)
Weight Decreased	7 (.22%)
Anorexia	6 (.19%)
Bundle Branch Block Right	6 (.19%)
Concussion	6 (.19%)
Drug Level Increased	6 (.19%)
Dyspnoea Exertional	6 (.19%)
Facial Bones Fracture	6 (.19%)
Haemorrhage	6 (.19%)
Hepatitis Cholestatic	6 (.19%)
Ileus	6 (.19%)

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

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

Muscle	459 (14.21%)
Renal Disorders	177 (5.48%)
Gastrointestinal Signs	146 (4.52%)
Neurological	130 (4.02%)
Hepatobiliary	120 (3.71%)
Therapeutic And Nontherapeutic Effe...	118 (3.65%)
Enzyme	93 (2.88%)
Suicidal And Self-injurious Behavio...	87 (2.69%)
Medication Errors	72 (2.23%)
Respiratory	68 (2.1%)
Cardiac Arrhythmias	67 (2.07%)
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Hepatic And Hepatobiliary	61 (1.89%)
Renal And Urinary Tract Investigati...	58 (1.8%)
Epidermal And Dermal Conditions	57 (1.76%)
Musculoskeletal And Connective Tiss...	56 (1.73%)
Injuries	50 (1.55%)
Lipid Analyses	50 (1.55%)
Hematology Investigations	45 (1.39%)
Urinary Tract Signs	45 (1.39%)
Electrolyte And Fluid Balance Condi...	41 (1.27%)
Joint	39 (1.21%)
Gastrointestinal Motility And Defec...	37 (1.15%)
Deliria	30 (.93%)
Infections - Pathogen Unspecified	30 (.93%)
Hematological And Lymphoid Tissue T...	29 (.9%)
Chemical Injury And Poisoning	25 (.77%)
Coronary Artery	24 (.74%)
Cardiac And Vascular Investigations	23 (.71%)
Physical Examination Topics	23 (.71%)
Anemias Nonhemolytic And Marrow Dep...	21 (.65%)
Appetite And General Nutritional	21 (.65%)
Headaches	20 (.62%)
Vision	20 (.62%)
Anxiety Disorders	19 (.59%)
Lifestyle Issues	19 (.59%)
Decreased And Nonspecific Blood Pre...	18 (.56%)
Glucose Metabolism Disorders	18 (.56%)
Movement Disorders	18 (.56%)
Sleep Disorders	18 (.56%)
Metabolic, Nutritional And Blood Ga...	16 (.5%)
Water, Electrolyte And Mineral	15 (.46%)
Fatal Outcomes	14 (.43%)
Mood Disorders	14 (.43%)
Seizures	14 (.43%)
Central Nervous System Vascular	13 (.4%)
Depressed Mood Disorders	13 (.4%)
Product Quality Issues	13 (.4%)
Toxicology And Therapeutic Drug Mon...	13 (.4%)
Acid-base	12 (.37%)
Allergic Conditions	12 (.37%)
Psychiatric	12 (.37%)
Angiedema And Urticaria	11 (.34%)
Gastrointestinal Hemorrhages	11 (.34%)
Bone And Joint Injuries	10 (.31%)
Exocrine Pancreas Conditions	10 (.31%)
Musculoskeletal And Connective Tiss...	10 (.31%)
Personality Disorders	10 (.31%)
Viral Infectious	10 (.31%)
Body Temperature Conditions	9 (.28%)
Mental Impairment	9 (.28%)
Cardiac Valve	8 (.25%)
Gastrointestinal Ulceration And Per...	8 (.25%)
Lipid Metabolism	8 (.25%)
Skin Appendage Conditions	7 (.22%)
Bacterial Infectious	6 (.19%)
Gastrointestinal Stenosis And Obstr...	6 (.19%)
Hearing	6 (.19%)
Inner Ear And Viiith Cranial Nerve	6 (.19%)
Upper Respiratory Tract Disorders	6 (.19%)
Vascular	6 (.19%)
Vascular Hemorrhagic	6 (.19%)
White Blood Cell	6 (.19%)
Cardiac Disorder Signs	5 (.15%)
Gastrointestinal	5 (.15%)
Gastrointestinal Conditions	5 (.15%)
Gastrointestinal Inflammatory Condi...	5 (.15%)
Investigations, Imaging And Histopa...	5 (.15%)
Respiratory And Mediastinal Neoplas...	5 (.15%)
Therapeutic Procedures And Supporti...	5 (.15%)
Benign Neoplasms Gastrointestinal	4 (.12%)
Bone, Calcium, Magnesium And Phosph...	4 (.12%)
Disturbances In Thinking	4 (.12%)
Economic And Housing Issues	4 (.12%)
Eye	4 (.12%)
Gallbladder	4 (.12%)
Immunology And Allergy	4 (.12%)
Ocular Infections, Irritations And ...	4 (.12%)
Oral Soft Tissue Conditions	4 (.12%)
Tissue	4 (.12%)
Vascular Hypertensive	4 (.12%)
Bone Disorders	3 (.09%)
Changes In Physical Activity	3 (.09%)
Dental And Gingival Conditions	3 (.09%)
Embolism And Thrombosis	3 (.09%)
Genitourinary Tract	3 (.09%)
Microbiology And Serology	3 (.09%)
Neuromuscular	3 (.09%)
Ocular Structural Change, Deposit A...	3 (.09%)
Procedural And Device Related Injur...	3 (.09%)
Red Blood Cell	3 (.09%)
Renal And Urinary Tract Neoplasms M...	3 (.09%)

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