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FLUVASTATIN SODIUM

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Fluvastatin Sodium Adverse Events Reported to the FDA Over Time

How are Fluvastatin Sodium adverse event reports trending over time?

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

Most Common Fluvastatin Sodium Adverse Events Reported to the FDA

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

Myalgia
227 (3%)
Blood Creatine Phosphokinase Increa...
150 (1.98%)
Rhabdomyolysis
130 (1.72%)
Alanine Aminotransferase Increased
113 (1.49%)
Aspartate Aminotransferase Increase...
110 (1.45%)
Muscular Weakness
108 (1.43%)
Nausea
91 (1.2%)
Arthralgia
81 (1.07%)
Vomiting
79 (1.04%)
Fatigue
75 (.99%)
Pain In Extremity
75 (.99%)
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Pyrexia
73 (.96%)
Drug Interaction
71 (.94%)
Asthenia
69 (.91%)
Gamma-glutamyltransferase Increased
66 (.87%)
Chest Pain
65 (.86%)
Headache
65 (.86%)
Renal Failure Acute
64 (.84%)
Malaise
62 (.82%)
Blood Creatinine Increased
61 (.8%)
Dyspnoea
58 (.77%)
Diarrhoea
54 (.71%)
Blood Alkaline Phosphatase Increase...
53 (.7%)
Death
53 (.7%)
Abdominal Pain
50 (.66%)
Dizziness
47 (.62%)
Hypoaesthesia
47 (.62%)
Hepatic Enzyme Increased
44 (.58%)
C-reactive Protein Increased
43 (.57%)
Muscle Spasms
42 (.55%)
Gait Disturbance
41 (.54%)
Blood Pressure Increased
40 (.53%)
Myopathy
40 (.53%)
Abdominal Pain Upper
39 (.51%)
Blood Cholesterol Increased
37 (.49%)
Fall
37 (.49%)
Liver Disorder
37 (.49%)
Back Pain
36 (.48%)
Chromaturia
36 (.48%)
Oedema Peripheral
36 (.48%)
Blood Bilirubin Increased
35 (.46%)
Cough
34 (.45%)
Hypertension
34 (.45%)
Loss Of Consciousness
33 (.44%)
Pruritus
33 (.44%)
Dehydration
32 (.42%)
Interstitial Lung Disease
32 (.42%)
Jaundice
31 (.41%)
Paraesthesia
31 (.41%)
Condition Aggravated
30 (.4%)
Blood Lactate Dehydrogenase Increas...
29 (.38%)
Pain
29 (.38%)
Syncope
29 (.38%)
International Normalised Ratio Incr...
28 (.37%)
Rash
27 (.36%)
Feeling Abnormal
26 (.34%)
Hepatitis
26 (.34%)
Renal Failure
26 (.34%)
Blood Urea Increased
25 (.33%)
Cardiac Disorder
25 (.33%)
Coronary Artery Disease
25 (.33%)
Drug Ineffective
25 (.33%)
Liver Function Test Abnormal
25 (.33%)
Pneumonia
25 (.33%)
Amyotrophic Lateral Sclerosis
24 (.32%)
Blood Glucose Increased
24 (.32%)
Depression
24 (.32%)
Hypoxia
24 (.32%)
Insomnia
24 (.32%)
Myoglobin Blood Increased
24 (.32%)
Tendon Rupture
24 (.32%)
Transaminases Increased
24 (.32%)
Cerebrovascular Accident
23 (.3%)
Hyperkalaemia
23 (.3%)
Polyneuropathy
23 (.3%)
Angina Pectoris
22 (.29%)
Musculoskeletal Stiffness
22 (.29%)
Abasia
21 (.28%)
Cholelithiasis
21 (.28%)
Hypersensitivity
21 (.28%)
Weight Decreased
21 (.28%)
Cholestasis
20 (.26%)
Haemoglobin Decreased
20 (.26%)
Anorexia
19 (.25%)
General Physical Health Deteriorati...
19 (.25%)
Muscle Disorder
19 (.25%)
Cytolytic Hepatitis
18 (.24%)
Hepatomegaly
18 (.24%)
Lung Disorder
18 (.24%)
Restless Legs Syndrome
18 (.24%)
Autoimmune Hepatitis
17 (.22%)
Face Oedema
17 (.22%)
Flushing
17 (.22%)
Liver Injury
17 (.22%)
Muscle Atrophy
17 (.22%)
Myocardial Infarction
17 (.22%)
Renal Impairment
17 (.22%)
Surgery
17 (.22%)
Antinuclear Antibody Positive
16 (.21%)
Arrhythmia
16 (.21%)
Blood Pressure Decreased
16 (.21%)

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This graph shows the top adverse events submitted to the FDA for Fluvastatin 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 Fluvastatin 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 Fluvastatin Sodium

What are the most common Fluvastatin 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 Fluvastatin 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 Fluvastatin 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 Fluvastatin Sodium According to Those Reporting Adverse Events

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

Hypercholesterolaemia
521
Hyperlipidaemia
316
Blood Cholesterol Increased
239
Dyslipidaemia
157
Drug Use For Unknown Indication
131
Product Used For Unknown Indication
112
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Blood Cholesterol
73
Lipid Metabolism Disorder
27
Prophylaxis
26
Renal Transplant
24
Blood Cholesterol Abnormal
17
Coronary Artery Disease
16
Hypertension
16
Ill-defined Disorder
14
Type Iia Hyperlipidaemia
12
Low Density Lipoprotein Increased
11
Acute Myocardial Infarction
10
Cardiovascular Event Prophylaxis
9
Lipids Abnormal
8
Lipids Increased
8
Heart Transplant
8
Osteoporosis Postmenopausal
6
Blood Cholesterol Decreased
5
Mixed Hyperlipidaemia
5
Metabolic Disorder
4
Diarrhoea
4
Blood Triglycerides
3
Myocardial Infarction
3
Diabetes Mellitus
3
Ischaemic Heart Disease Prophylaxis
3
Neoplasm
3
Cerebrovascular Spasm
3
Lipids
3
Cardiovascular Disorder
2
Heart Rate Increased
2
Hepatitis C
2
Stent Placement
2
Unevaluable Event
2
Insomnia
2
Prostate Cancer
2
Myocardial Ischaemia
2
Transient Ischaemic Attack
2
Blood Triglycerides Increased
2
Colorectal Cancer Metastatic
2
Diastolic Dysfunction
2
Metabolic Syndrome
1
Cardiac Disorder
1
Gout
1
Liver Injury
1
Xanthelasma
1
Nephrotic Syndrome
1

Drug Labels

LabelLabelerEffective
Fluvastatin SodiumerSandoz Inc22-MAY-12
LescolNovartis Pharmaceuticals Corporation31-OCT-12
LescolxlNovartis Pharmaceuticals Corporation31-OCT-12
Fluvastatin SodiumMylan Pharmaceuticals Inc.25-JAN-13

Fluvastatin Sodium Case Reports

What Fluvastatin 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 Fluvastatin 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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