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PRAVASTATIN SODIUM

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Pravastatin Sodium Adverse Events Reported to the FDA Over Time

How are Pravastatin Sodium adverse event reports trending over time?

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

Most Common Pravastatin Sodium Adverse Events Reported to the FDA

What are the most common Pravastatin Sodium 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 Sodium, 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 Sodium 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 Sodium

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

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

Common Uses of Pravastatin Sodium According to Those Reporting Adverse Events

Why are people taking Pravastatin Sodium, according to those reporting adverse events to the FDA?

Blood Cholesterol Increased
2584
Product Used For Unknown Indication
1465
Hyperlipidaemia
1138
Hypercholesterolaemia
1110
Drug Use For Unknown Indication
1012
Blood Cholesterol
649
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Dyslipidaemia
329
Blood Cholesterol Abnormal
198
Prophylaxis
87
Ill-defined Disorder
83
Hypertension
80
Coronary Artery Disease
60
Lipids Increased
48
Blood Triglycerides Increased
43
Cardiac Disorder
38
Lipid Metabolism Disorder
37
Low Density Lipoprotein Increased
35
Myocardial Infarction
29
Lipids Abnormal
22
Myocardial Ischaemia
15
Diabetes Mellitus
15
Cardiovascular Event Prophylaxis
14
Hypertriglyceridaemia
14
Blood Cholesterol Decreased
14
Metabolic Disorder
12
Angina Pectoris
12
Cardiovascular Disorder
11
Atrial Fibrillation
10
Acute Myocardial Infarction
9
Hypocholesterolaemia
8
Blood Pressure
7
Cerebrovascular Accident
7
Type Iia Hyperlipidaemia
7
Lipids
7
Arteriosclerosis
7
Transient Ischaemic Attack
6
Acute Myeloid Leukaemia
5
Stent Placement
5
Coronary Arterial Stent Insertion
5
Unevaluable Event
5
Hiv Infection
5
Type 2 Diabetes Mellitus
5
Thrombosis Prophylaxis
5
Rhabdomyolysis
5
Cerebrovascular Accident Prophylaxi...
5
Coronary Artery Bypass
5
Low Density Lipoprotein
5
Gout
5
Acute Coronary Syndrome
4
Depression
4
Rheumatoid Arthritis
4

Drug Labels

LabelLabelerEffective
Pravastatin SodiumMylan Pharmaceuticals Inc.11-SEP-08
Pravastatin SodiumPhysicians Total Care, Inc.12-JAN-10
Pravastatin SodiumState of Florida DOH Central Pharmacy01-JUN-10
Pravastatin SodiumState of Florida DOH Central Pharmacy01-JUN-10
Pravastatin SodiumState of Florida DOH Central Pharmacy01-JUN-10
Pravastatin SodiumMajor Pharmaceuticals30-JUL-10
Pravastatin SodiumRebel Distributors Corp10-NOV-10
PravastatinNCS HealthCare of KY, Inc dba Vangard Labs19-NOV-10
Pravastatin SodiumREMEDYREPACK INC. 08-JUN-11
Pravastatin SodiumREMEDYREPACK INC. 20-SEP-11
Pravastatin SodiumREMEDYREPACK INC. 17-NOV-11
Pravastatin SodiumREMEDYREPACK INC. 30-NOV-11
Pravastatin SodiumApotex Corp.04-JAN-12
Pravastatin SodiumGolden State Medical Supply, Inc.09-JAN-12
Pravastatin SodiumRebel Distributors Corp24-JAN-12
Pravastatin SodiumNCS HealthCare of KY, Inc dba Vangard Labs15-FEB-12
Pravastatin SodiumLegacy Pharmaceutical Packaging27-FEB-12
Pravastatin SodiumCobalt Laboratories Inc.01-MAR-12
Pravastatin SodiumDr.Reddy's Laboratories Limited02-APR-12
Pravastatin SodiumPD-Rx Pharmaceuticals, Inc.02-APR-12
Pravastatin SodiumPD-Rx Pharmaceuticals, Inc.02-APR-12
Pravastatin SodiumMylan Institutional Inc.06-APR-12
Pravastatin SodiumRebel Distributors Corp11-APR-12
Pravastatin SodiumGlenmark Generics Inc., USA30-APR-12
Pravastatin SodiumCardinal Health09-MAY-12
Pravastatin SodiumAmerican Health Packaging09-JUL-12
Pravastatin SodiumMylan Pharmaceuticals Inc.31-JUL-12
Pravastatin SodiumInternational Labs, Inc.19-SEP-12
Pravastatin SodiumMajor Pharmaceuticals05-OCT-12
Pravastatin SodiumZydus Pharmaceuticals (USA) Inc.20-OCT-12
Pravastatin SodiumPD-Rx Pharmaceuticals, Inc.20-OCT-12
Pravastatin SodiumPD-Rx Pharmaceuticals, Inc.20-OCT-12
PravacholE.R. Squibb & Sons, L.L.C.31-OCT-12
Pravastatin SodiumAphena Pharma Solutions - Tennessee, Inc.07-NOV-12
Pravastatin SodiumCadila Healthcare Limited22-NOV-12
Pravastatin SodiumInternational Labs, Inc.03-DEC-12
Pravastatin SodiumTeva Pharmaceuticals USA Inc07-DEC-12
Pravastatin SodiumNCS HealthCare of KY, Inc dba Vangard Labs20-DEC-12
Pravastatin SodiumApotex Corp.01-JAN-13
Pravastatin SodiumLupin Pharmaceuticals, Inc.04-JAN-13
Pravastatin SodiumPreferred Pharmaceuticals, Inc.07-JAN-13
Pravastatin SodiumTeva Pharmaceuticals USA Inc08-JAN-13
Pravastatin SodiumBryant Ranch Prepack21-JAN-13
Pravastatin SodiumBryant Ranch Prepack13-FEB-13
Pravastatin SodiumBryant Ranch Prepack13-FEB-13
Pravastatin SodiumCardinal Health19-MAR-13
Pravastatin SodiumMcKesson Contract Packaging12-APR-13
Pravastatin SodiumLupin Pharmaceuticals, Inc.15-APR-13
Pravastatin SodiumInternational Labs, Inc.03-MAY-13

Pravastatin Sodium Case Reports

What Pravastatin Sodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Pravastatin Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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