SIMVASTATIN

Simvastatin Adverse Events Reported to the FDA Over Time

How are Simvastatin adverse event reports trending over time?

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

Most Common Simvastatin Adverse Events Reported to the FDA

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

Rhabdomyolysis	1983 (4.43%)
Myalgia	1368 (3.06%)
Drug Interaction	1253 (2.8%)
Renal Failure Acute	783 (1.75%)
Blood Creatine Phosphokinase Increa...	712 (1.59%)
Muscular Weakness	632 (1.41%)
Asthenia	515 (1.15%)
Fatigue	493 (1.1%)
Pain In Extremity	484 (1.08%)
Alanine Aminotransferase Increased	406 (.91%)
Arthralgia	405 (.91%)
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Nausea	405 (.91%)
Diarrhoea	363 (.81%)
Pain	358 (.8%)
Dyspnoea	347 (.78%)
Malaise	347 (.78%)
Muscle Spasms	338 (.76%)
Vomiting	323 (.72%)
Dizziness	316 (.71%)
Myopathy	302 (.67%)
Gait Disturbance	295 (.66%)
Myositis	291 (.65%)
Fall	288 (.64%)
Liver Function Test Abnormal	288 (.64%)
Renal Failure	285 (.64%)
Headache	264 (.59%)
Weight Decreased	262 (.59%)
Aspartate Aminotransferase Increase...	257 (.57%)
Completed Suicide	243 (.54%)
Depression	234 (.52%)
Rash	224 (.5%)
Blood Creatinine Increased	216 (.48%)
Amnesia	209 (.47%)
Abdominal Pain	205 (.46%)
Oedema Peripheral	204 (.46%)
Confusional State	196 (.44%)
International Normalised Ratio Incr...	191 (.43%)
Decreased Appetite	184 (.41%)
Hypotension	180 (.4%)
Drug Ineffective	172 (.38%)
Pyrexia	169 (.38%)
Abdominal Pain Upper	168 (.38%)
Overdose	167 (.37%)
Insomnia	165 (.37%)
Chest Pain	164 (.37%)
Atrial Fibrillation	161 (.36%)
Memory Impairment	156 (.35%)
Dehydration	154 (.34%)
Hepatic Enzyme Increased	152 (.34%)
Pneumonia	151 (.34%)
Chromaturia	150 (.34%)
Anxiety	149 (.33%)
Myocardial Infarction	148 (.33%)
Blood Cholesterol Increased	146 (.33%)
Tendon Rupture	145 (.32%)
Feeling Abnormal	143 (.32%)
Interstitial Lung Disease	143 (.32%)
Renal Impairment	143 (.32%)
Pruritus	142 (.32%)
Condition Aggravated	141 (.32%)
Cough	140 (.31%)
Abasia	139 (.31%)
Back Pain	134 (.3%)
Syncope	128 (.29%)
Alopecia	127 (.28%)
Lethargy	127 (.28%)
Loss Of Consciousness	126 (.28%)
Blood Alkaline Phosphatase Increase...	125 (.28%)
Blood Bilirubin Increased	125 (.28%)
Musculoskeletal Pain	125 (.28%)
Cerebrovascular Accident	124 (.28%)
Haemoglobin Decreased	123 (.27%)
Hypoaesthesia	121 (.27%)
Jaundice	120 (.27%)
Respiratory Failure	114 (.25%)
White Blood Cell Count Increased	114 (.25%)
Hyperhidrosis	113 (.25%)
Suicidal Ideation	109 (.24%)
Blood Pressure Increased	108 (.24%)
Hyperkalaemia	108 (.24%)
Urinary Tract Infection	108 (.24%)
Palpitations	103 (.23%)
Agitation	102 (.23%)
Blood Glucose Increased	101 (.23%)
Mobility Decreased	101 (.23%)
Paraesthesia	101 (.23%)
Haemodialysis	100 (.22%)
Nightmare	100 (.22%)
Contusion	98 (.22%)
Gamma-glutamyltransferase Increased	97 (.22%)
Musculoskeletal Stiffness	97 (.22%)
Death	96 (.21%)
Muscle Atrophy	96 (.21%)
Acute Respiratory Distress Syndrome	95 (.21%)
Somnolence	95 (.21%)
Cardiac Arrest	93 (.21%)
Tremor	93 (.21%)
Asthma	88 (.2%)
Convulsion	87 (.19%)
Hepatotoxicity	87 (.19%)
Pulmonary Fibrosis	87 (.19%)

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

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

Muscle	5403 (12.08%)
Neurological	1751 (3.91%)
Therapeutic And Nontherapeutic Effe...	1622 (3.62%)
Renal Disorders	1478 (3.3%)
Hepatobiliary	1454 (3.25%)
Gastrointestinal Signs	1443 (3.22%)
Epidermal And Dermal Conditions	1430 (3.2%)
Respiratory	1192 (2.66%)
Musculoskeletal And Connective Tiss...	1111 (2.48%)
Enzyme	956 (2.14%)
Hepatic And Hepatobiliary	843 (1.88%)
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Injuries	765 (1.71%)
Hematology Investigations	756 (1.69%)
Infections - Pathogen Unspecified	747 (1.67%)
Cardiac Arrhythmias	697 (1.56%)
Joint	649 (1.45%)
Mental Impairment	540 (1.21%)
Renal And Urinary Tract Investigati...	524 (1.17%)
Lower Respiratory Tract Disorders	523 (1.17%)
Gastrointestinal Motility And Defec...	520 (1.16%)
Medication Errors	506 (1.13%)
Urinary Tract Signs	488 (1.09%)
Sleep Disorders	454 (1.01%)
Cardiac And Vascular Investigations	428 (.96%)
Electrolyte And Fluid Balance Condi...	428 (.96%)
Suicidal And Self-injurious Behavio...	421 (.94%)
Movement Disorders	418 (.93%)
Anxiety Disorders	390 (.87%)
Physical Examination Topics	389 (.87%)
Lipid Analyses	383 (.86%)
Coronary Artery	362 (.81%)
Central Nervous System Vascular	355 (.79%)
Skin Appendage Conditions	338 (.76%)
Appetite And General Nutritional	333 (.74%)
Depressed Mood Disorders	291 (.65%)
Decreased And Nonspecific Blood Pre...	284 (.63%)
Headaches	279 (.62%)
Deliria	255 (.57%)
Metabolic, Nutritional And Blood Ga...	249 (.56%)
Glucose Metabolism Disorders	216 (.48%)
Peripheral Neuropathies	202 (.45%)
Vision	201 (.45%)
Lifestyle Issues	192 (.43%)
Water, Electrolyte And Mineral	191 (.43%)
Neuromuscular	190 (.42%)
Hematological And Lymphoid Tissue T...	188 (.42%)
Oral Soft Tissue Conditions	187 (.42%)
Cardiac Disorder Signs	186 (.42%)
Body Temperature Conditions	180 (.4%)
Bacterial Infectious	174 (.39%)
Gastrointestinal Hemorrhages	174 (.39%)
Exocrine Pancreas Conditions	170 (.38%)
Bronchial Disorders	160 (.36%)
White Blood Cell	157 (.35%)
Heart Failures	153 (.34%)
Allergic Conditions	150 (.34%)
Mood Disorders	144 (.32%)
Platelet	144 (.32%)
Vascular	144 (.32%)
Anemias Nonhemolytic And Marrow Dep...	142 (.32%)
Personality Disorders	136 (.3%)
Seizures	132 (.3%)
Eye	130 (.29%)
Product Quality Issues	128 (.29%)
Angiedema And Urticaria	120 (.27%)
Chemical Injury And Poisoning	116 (.26%)
Pleural	116 (.26%)
Psychiatric	116 (.26%)
Fatal Outcomes	115 (.26%)
Protein And Chemistry Analyses	108 (.24%)
Upper Respiratory Tract Disorders	106 (.24%)
Gastrointestinal Inflammatory Condi...	100 (.22%)
Vascular Hypertensive	96 (.21%)
Skin Vascular Abnormalities	95 (.21%)
Ocular Infections, Irritations And ...	91 (.2%)
Tendon, Ligament And Cartilage	91 (.2%)
Arteriosclerosis, Stenosis, Vascula...	90 (.2%)
Tongue Conditions	90 (.2%)
Disturbances In Thinking	86 (.19%)
Viral Infectious	85 (.19%)
Procedural And Device Related Injur...	79 (.18%)
Pulmonary Vascular	78 (.17%)
Immunology And Allergy	76 (.17%)
Inner Ear And Viiith Cranial Nerve	74 (.17%)
Sexual Function And Fertility	71 (.16%)
Tissue	69 (.15%)
Aneurysms And Artery Dissections	64 (.14%)
Thyroid Gland	62 (.14%)
Acid-base	61 (.14%)
Gastrointestinal Ulceration And Per...	61 (.14%)
Toxicology And Therapeutic Drug Mon...	61 (.14%)
Coagulopathies And Bleeding Diathes...	60 (.13%)
Myocardial	59 (.13%)
Vascular Hemorrhagic	58 (.13%)
Bone And Joint Injuries	57 (.13%)
Bone Disorders	57 (.13%)
Pericardial	57 (.13%)
Gallbladder	56 (.13%)
Psychiatric And Behavioural Symptom...	56 (.13%)
Respiratory Tract Therapeutic Proce...	56 (.13%)
Connective Tissue Disorders	55 (.12%)

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