ATORVASTATIN

Atorvastatin Adverse Events Reported to the FDA Over Time

How are Atorvastatin adverse event reports trending over time?

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

Most Common Atorvastatin Adverse Events Reported to the FDA

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

Myalgia	5383 (3.74%)
Pain In Extremity	2613 (1.82%)
Muscle Spasms	2092 (1.45%)
Arthralgia	1995 (1.39%)
Blood Cholesterol Increased	1961 (1.36%)
Muscular Weakness	1911 (1.33%)
Death	1865 (1.3%)
Rhabdomyolysis	1824 (1.27%)
Fatigue	1789 (1.24%)
Asthenia	1770 (1.23%)
Pain	1666 (1.16%)
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Blood Creatine Phosphokinase Increa...	1493 (1.04%)
Malaise	1236 (.86%)
Myocardial Infarction	1227 (.85%)
Drug Interaction	1145 (.8%)
Drug Ineffective	1124 (.78%)
Gait Disturbance	1087 (.76%)
Amnesia	1057 (.73%)
Nausea	1027 (.71%)
Dizziness	1005 (.7%)
Headache	985 (.68%)
Weight Decreased	921 (.64%)
Back Pain	914 (.64%)
Dyspnoea	914 (.64%)
Cerebrovascular Accident	906 (.63%)
Hypertension	874 (.61%)
Fall	844 (.59%)
Insomnia	821 (.57%)
Alanine Aminotransferase Increased	811 (.56%)
Aspartate Aminotransferase Increase...	778 (.54%)
Depression	729 (.51%)
Diarrhoea	726 (.5%)
Oedema Peripheral	723 (.5%)
Feeling Abnormal	722 (.5%)
Rash	695 (.48%)
Chest Pain	684 (.48%)
Neuropathy Peripheral	646 (.45%)
Hypoaesthesia	637 (.44%)
Pruritus	630 (.44%)
Diabetes Mellitus	625 (.43%)
Blood Triglycerides Increased	615 (.43%)
Renal Failure Acute	610 (.42%)
Muscle Disorder	586 (.41%)
Liver Disorder	576 (.4%)
Abasia	571 (.4%)
Paraesthesia	564 (.39%)
Memory Impairment	562 (.39%)
Abdominal Pain Upper	560 (.39%)
Weight Increased	543 (.38%)
Renal Failure	541 (.38%)
Hepatic Enzyme Increased	534 (.37%)
Cardiac Disorder	529 (.37%)
Muscle Atrophy	514 (.36%)
Constipation	507 (.35%)
Blood Glucose Increased	498 (.35%)
Liver Function Test Abnormal	497 (.35%)
Pyrexia	493 (.34%)
Vomiting	476 (.33%)
Arthritis	462 (.32%)
Low Density Lipoprotein Increased	456 (.32%)
Musculoskeletal Pain	456 (.32%)
Myopathy	442 (.31%)
Alopecia	441 (.31%)
Balance Disorder	437 (.3%)
Musculoskeletal Stiffness	435 (.3%)
Confusional State	434 (.3%)
Hypersensitivity	426 (.3%)
Abdominal Pain	402 (.28%)
Anxiety	395 (.27%)
Blood Pressure Increased	390 (.27%)
Pneumonia	379 (.26%)
Condition Aggravated	370 (.26%)
Dysphagia	365 (.25%)
Wrong Technique In Drug Usage Proce...	365 (.25%)
High Density Lipoprotein Decreased	364 (.25%)
Flatulence	355 (.25%)
Blood Alkaline Phosphatase Increase...	345 (.24%)
Hepatic Function Abnormal	344 (.24%)
Gamma-glutamyltransferase Increased	337 (.23%)
Abdominal Discomfort	327 (.23%)
Tremor	327 (.23%)
Dysstasia	322 (.22%)
Cough	315 (.22%)
Blood Creatinine Increased	312 (.22%)
Jaundice	309 (.21%)
Dyspepsia	306 (.21%)
Dehydration	304 (.21%)
Hepatitis	302 (.21%)
Somnolence	300 (.21%)
Coronary Artery Occlusion	299 (.21%)
Atrial Fibrillation	295 (.21%)
Activities Of Daily Living Impaired	293 (.2%)
Cognitive Disorder	293 (.2%)
Hypotension	291 (.2%)
Neck Pain	290 (.2%)
No Adverse Event	290 (.2%)
Arthropathy	283 (.2%)
Chromaturia	279 (.19%)
Renal Disorder	277 (.19%)
Erythema	275 (.19%)
Burning Sensation	274 (.19%)

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

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

Muscle	13802 (9.6%)
Neurological	6061 (4.21%)
Musculoskeletal And Connective Tiss...	5740 (3.99%)
Gastrointestinal Signs	4347 (3.02%)
Lipid Analyses	4035 (2.81%)
Epidermal And Dermal Conditions	3823 (2.66%)
Joint	3642 (2.53%)
Hepatobiliary	3456 (2.4%)
Hepatic And Hepatobiliary	3422 (2.38%)
Therapeutic And Nontherapeutic Effe...	2881 (2%)
Injuries	2709 (1.88%)
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Respiratory	2576 (1.79%)
Mental Impairment	2342 (1.63%)
Enzyme	2304 (1.6%)
Infections - Pathogen Unspecified	2302 (1.6%)
Coronary Artery	2242 (1.56%)
Renal Disorders	1964 (1.37%)
Fatal Outcomes	1913 (1.33%)
Physical Examination Topics	1834 (1.28%)
Central Nervous System Vascular	1637 (1.14%)
Gastrointestinal Motility And Defec...	1566 (1.09%)
Hematology Investigations	1538 (1.07%)
Cardiac And Vascular Investigations	1439 (1%)
Cardiac Arrhythmias	1358 (.94%)
Sleep Disorders	1276 (.89%)
Medication Errors	1256 (.87%)
Movement Disorders	1138 (.79%)
Urinary Tract Signs	1133 (.79%)
Lifestyle Issues	1126 (.78%)
Headaches	1079 (.75%)
Glucose Metabolism Disorders	1076 (.75%)
Peripheral Neuropathies	1072 (.75%)
Vascular Hypertensive	1038 (.72%)
Metabolic, Nutritional And Blood Ga...	1021 (.71%)
Anxiety Disorders	980 (.68%)
Renal And Urinary Tract Investigati...	898 (.62%)
Cardiac Disorder Signs	888 (.62%)
Skin Appendage Conditions	884 (.61%)
Depressed Mood Disorders	880 (.61%)
Allergic Conditions	799 (.56%)
Vision	761 (.53%)
Arteriosclerosis, Stenosis, Vascula...	751 (.52%)
Bone And Joint Injuries	748 (.52%)
Lower Respiratory Tract Disorders	741 (.52%)
Deliria	727 (.51%)
Electrolyte And Fluid Balance Condi...	704 (.49%)
Appetite And General Nutritional	684 (.48%)
Bone Disorders	578 (.4%)
Water, Electrolyte And Mineral	544 (.38%)
Therapeutic Procedures And Supporti...	535 (.37%)
Body Temperature Conditions	531 (.37%)
Viral Infectious	517 (.36%)
Vascular	508 (.35%)
Procedural And Device Related Injur...	507 (.35%)
Upper Respiratory Tract Disorders	503 (.35%)
Decreased And Nonspecific Blood Pre...	494 (.34%)
Anemias Nonhemolytic And Marrow Dep...	482 (.34%)
Heart Failures	467 (.32%)
Eye	438 (.3%)
Musculoskeletal And Connective Tiss...	429 (.3%)
Neuromuscular	416 (.29%)
Vascular Therapeutic Procedures	409 (.28%)
Hearing	400 (.28%)
Exocrine Pancreas Conditions	395 (.27%)
Gastrointestinal Conditions	383 (.27%)
Gastrointestinal Hemorrhages	377 (.26%)
Tendon, Ligament And Cartilage	370 (.26%)
Bronchial Disorders	360 (.25%)
Bacterial Infectious	354 (.25%)
Inner Ear And Viiith Cranial Nerve	342 (.24%)
Seizures	340 (.24%)
Angiedema And Urticaria	334 (.23%)
Mood Disorders	334 (.23%)
Oral Soft Tissue Conditions	331 (.23%)
Embolism And Thrombosis	324 (.23%)
Suicidal And Self-injurious Behavio...	324 (.23%)
Bone And Joint Therapeutic Procedur...	322 (.22%)
Thyroid Gland	316 (.22%)
Gallbladder	312 (.22%)
Sexual Function And Fertility	311 (.22%)
Product Quality Issues	309 (.21%)
Tongue Conditions	306 (.21%)
Immunology And Allergy	304 (.21%)
Disturbances In Thinking	302 (.21%)
White Blood Cell	298 (.21%)
Chemical Injury And Poisoning	286 (.2%)
Gastrointestinal Neoplasms Malignan...	283 (.2%)
Cardiac Therapeutic Procedures	279 (.19%)
Hematological And Lymphoid Tissue T...	266 (.18%)
Myocardial	265 (.18%)
Protein And Chemistry Analyses	264 (.18%)
Psychiatric	262 (.18%)
Tissue	249 (.17%)
Skin Vascular Abnormalities	248 (.17%)
Vascular Hemorrhagic	243 (.17%)
Platelet	239 (.17%)
Personality Disorders	231 (.16%)
Miscellaneous And Site Unspecified ...	224 (.16%)
Lipid Metabolism	223 (.16%)
Investigations, Imaging And Histopa...	222 (.15%)
Salivary Gland Conditions	218 (.15%)

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