PRAVASTATIN

Pravastatin Adverse Events Reported to the FDA Over Time

How are Pravastatin adverse event reports trending over time?

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

Most Common Pravastatin Adverse Events Reported to the FDA

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

Myalgia	498 (3.54%)
Pain In Extremity	202 (1.43%)
Rhabdomyolysis	199 (1.41%)
Fatigue	185 (1.31%)
Asthenia	173 (1.23%)
Arthralgia	169 (1.2%)
Drug Interaction	166 (1.18%)
Dizziness	155 (1.1%)
Muscular Weakness	149 (1.06%)
Drug Ineffective	147 (1.04%)
Nausea	146 (1.04%)
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Muscle Spasms	144 (1.02%)
Blood Creatine Phosphokinase Increa...	136 (.97%)
Renal Failure Acute	115 (.82%)
Dyspnoea	114 (.81%)
Death	109 (.77%)
Pain	108 (.77%)
Headache	107 (.76%)
Diarrhoea	99 (.7%)
Blood Cholesterol Increased	94 (.67%)
Malaise	92 (.65%)
Rash	90 (.64%)
Oedema Peripheral	81 (.58%)
Renal Failure	81 (.58%)
Alanine Aminotransferase Increased	80 (.57%)
Weight Decreased	74 (.53%)
Chest Pain	72 (.51%)
Gait Disturbance	72 (.51%)
Back Pain	71 (.5%)
Abdominal Pain Upper	69 (.49%)
Aspartate Aminotransferase Increase...	68 (.48%)
Fall	68 (.48%)
Interstitial Lung Disease	67 (.48%)
Vomiting	65 (.46%)
Alopecia	64 (.45%)
Hepatic Enzyme Increased	64 (.45%)
Pruritus	64 (.45%)
Pyrexia	64 (.45%)
Insomnia	59 (.42%)
Amnesia	57 (.4%)
Anaemia	55 (.39%)
Myocardial Infarction	54 (.38%)
Depression	53 (.38%)
Pneumonia	52 (.37%)
Neuropathy Peripheral	51 (.36%)
Confusional State	50 (.36%)
Liver Function Test Abnormal	49 (.35%)
Hypoaesthesia	48 (.34%)
Pancreatitis Acute	48 (.34%)
Gamma-glutamyltransferase Increased	46 (.33%)
International Normalised Ratio Incr...	46 (.33%)
Liver Disorder	46 (.33%)
Paraesthesia	46 (.33%)
Dehydration	45 (.32%)
Feeling Abnormal	45 (.32%)
Musculoskeletal Pain	45 (.32%)
Vision Blurred	45 (.32%)
Abdominal Pain	44 (.31%)
Drug Hypersensitivity	44 (.31%)
Rectal Haemorrhage	44 (.31%)
Sleep Disorder	44 (.31%)
Decreased Appetite	43 (.31%)
Abasia	41 (.29%)
Tendon Rupture	41 (.29%)
Hyperhidrosis	40 (.28%)
Hypertension	40 (.28%)
Influenza Like Illness	40 (.28%)
Musculoskeletal Stiffness	40 (.28%)
Anxiety	39 (.28%)
Myopathy	38 (.27%)
Palpitations	38 (.27%)
Dyspepsia	37 (.26%)
Thrombocytopenia	37 (.26%)
Weight Increased	37 (.26%)
Colitis	36 (.26%)
Condition Aggravated	36 (.26%)
Guillain-barre Syndrome	36 (.26%)
Loss Of Consciousness	36 (.26%)
Abnormal Dreams	35 (.25%)
Blood Alkaline Phosphatase Increase...	35 (.25%)
Blood Pressure Increased	35 (.25%)
Cough	35 (.25%)
Asthma	34 (.24%)
Atrial Fibrillation	34 (.24%)
Blood Creatinine Increased	34 (.24%)
Haemoglobin Decreased	34 (.24%)
Muscle Disorder	34 (.24%)
Somnolence	34 (.24%)
Flatulence	33 (.23%)
High Density Lipoprotein Decreased	33 (.23%)
Urticaria	33 (.23%)
Erythema	32 (.23%)
Low Density Lipoprotein Increased	32 (.23%)
Abdominal Discomfort	31 (.22%)
Completed Suicide	31 (.22%)
Muscle Atrophy	31 (.22%)
Myositis	31 (.22%)
C-reactive Protein Increased	30 (.21%)
Hepatitis	30 (.21%)
Diplopia	29 (.21%)
Gastrointestinal Haemorrhage	29 (.21%)

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

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

Muscle	1198 (8.51%)
Neurological	592 (4.2%)
Epidermal And Dermal Conditions	540 (3.83%)
Gastrointestinal Signs	489 (3.47%)
Musculoskeletal And Connective Tiss...	402 (2.85%)
Therapeutic And Nontherapeutic Effe...	381 (2.71%)
Respiratory	378 (2.68%)
Hepatobiliary	362 (2.57%)
Hepatic And Hepatobiliary	360 (2.56%)
Injuries	265 (1.88%)
Renal Disorders	260 (1.85%)
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Joint	251 (1.78%)
Hematology Investigations	234 (1.66%)
Enzyme	207 (1.47%)
Infections - Pathogen Unspecified	204 (1.45%)
Lipid Analyses	204 (1.45%)
Cardiac Arrhythmias	181 (1.29%)
Cardiac And Vascular Investigations	158 (1.12%)
Sleep Disorders	156 (1.11%)
Skin Appendage Conditions	154 (1.09%)
Lower Respiratory Tract Disorders	151 (1.07%)
Physical Examination Topics	151 (1.07%)
Gastrointestinal Motility And Defec...	148 (1.05%)
Peripheral Neuropathies	127 (.9%)
Fatal Outcomes	117 (.83%)
Urinary Tract Signs	117 (.83%)
Headaches	115 (.82%)
Mental Impairment	115 (.82%)
Coronary Artery	111 (.79%)
Renal And Urinary Tract Investigati...	105 (.75%)
Electrolyte And Fluid Balance Condi...	104 (.74%)
Gastrointestinal Hemorrhages	104 (.74%)
Anemias Nonhemolytic And Marrow Dep...	102 (.72%)
Vision	99 (.7%)
Anxiety Disorders	90 (.64%)
Medication Errors	90 (.64%)
Appetite And General Nutritional	88 (.62%)
White Blood Cell	87 (.62%)
Bronchial Disorders	86 (.61%)
Movement Disorders	86 (.61%)
Metabolic, Nutritional And Blood Ga...	85 (.6%)
Exocrine Pancreas Conditions	82 (.58%)
Cardiac Disorder Signs	81 (.58%)
Suicidal And Self-injurious Behavio...	80 (.57%)
Allergic Conditions	79 (.56%)
Body Temperature Conditions	77 (.55%)
Central Nervous System Vascular	69 (.49%)
Depressed Mood Disorders	67 (.48%)
Deliria	66 (.47%)
Lifestyle Issues	66 (.47%)
Gastrointestinal Inflammatory Condi...	65 (.46%)
Bacterial Infectious	63 (.45%)
Gastrointestinal Ulceration And Per...	63 (.45%)
Oral Soft Tissue Conditions	58 (.41%)
Platelet	58 (.41%)
Cardiac Valve	52 (.37%)
Mood Disorders	50 (.36%)
Product Quality Issues	50 (.36%)
Protein And Chemistry Analyses	50 (.36%)
Bone And Joint Injuries	49 (.35%)
Vascular	49 (.35%)
Upper Respiratory Tract Disorders	48 (.34%)
Viral Infectious	48 (.34%)
Decreased And Nonspecific Blood Pre...	47 (.33%)
Angiedema And Urticaria	46 (.33%)
Gastrointestinal	46 (.33%)
Glucose Metabolism Disorders	45 (.32%)
Vascular Hemorrhagic	45 (.32%)
Disturbances In Thinking	43 (.31%)
Neuromuscular	43 (.31%)
Water, Electrolyte And Mineral	42 (.3%)
Heart Failures	41 (.29%)
Inner Ear And Viiith Cranial Nerve	41 (.29%)
Pulmonary Vascular	41 (.29%)
Vascular Hypertensive	41 (.29%)
Chemical Injury And Poisoning	37 (.26%)
Skin Vascular Abnormalities	37 (.26%)
Tendon, Ligament And Cartilage	35 (.25%)
Bone Disorders	33 (.23%)
Immunology And Allergy	33 (.23%)
Psychiatric	32 (.23%)
Sexual Function And Fertility	31 (.22%)
Arteriosclerosis, Stenosis, Vascula...	30 (.21%)
Tongue Conditions	30 (.21%)
Eye	28 (.2%)
Personality Disorders	28 (.2%)
Coagulopathies And Bleeding Diathes...	27 (.19%)
Skin And Subcutaneous Tissue	27 (.19%)
Gastrointestinal Neoplasms Malignan...	26 (.18%)
Lipid Metabolism	26 (.18%)
Tissue	25 (.18%)
Acid-base	24 (.17%)
Ocular Neuromuscular	24 (.17%)
Procedural And Device Related Injur...	24 (.17%)
Myocardial	23 (.16%)
Dental And Gingival Conditions	22 (.16%)
Musculoskeletal And Connective Tiss...	22 (.16%)
Seizures	22 (.16%)
Cornification And Dystrophic Skin	21 (.15%)
Ocular Infections, Irritations And ...	21 (.15%)
Therapeutic Procedures And Supporti...	21 (.15%)

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