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Aprovel Tabs Adverse Events Reported to the FDA Over Time

How are Aprovel Tabs adverse event reports trending over time?

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

Most Common Aprovel Tabs Adverse Events Reported to the FDA

What are the most common Aprovel Tabs adverse events reported to the FDA?

Renal Failure Acute
32 (2.99%)
Confusional State
24 (2.24%)
Hyponatraemia
24 (2.24%)
Fall
23 (2.15%)
Diarrhoea
22 (2.06%)
Hyperkalaemia
22 (2.06%)
Renal Failure
21 (1.96%)
Blood Creatine Phosphokinase Increa...
18 (1.68%)
Hypoglycaemia
15 (1.4%)
Asthenia
13 (1.21%)
Anaemia
12 (1.12%)
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Dehydration
12 (1.12%)
Malaise
12 (1.12%)
Lactic Acidosis
11 (1.03%)
Hypotension
10 (.93%)
Vertigo
10 (.93%)
Vomiting
10 (.93%)
Anorexia
9 (.84%)
Depressed Level Of Consciousness
9 (.84%)
Dyspnoea
8 (.75%)
Myalgia
8 (.75%)
Pancreatitis Acute
8 (.75%)
Chest Pain
7 (.65%)
Cholestasis
7 (.65%)
Deep Vein Thrombosis
7 (.65%)
Drug Interaction
7 (.65%)
Hepatitis
7 (.65%)
Hyperhidrosis
7 (.65%)
Interstitial Lung Disease
7 (.65%)
Metastases To Liver
7 (.65%)
Nausea
7 (.65%)
Overdose
7 (.65%)
Rhabdomyolysis
7 (.65%)
Septic Shock
7 (.65%)
Aspartate Aminotransferase Increase...
6 (.56%)
Blood Pressure Increased
6 (.56%)
Feeling Abnormal
6 (.56%)
Hypertension
6 (.56%)
Metabolic Acidosis
6 (.56%)
Myocardial Infarction
6 (.56%)
Pruritus
6 (.56%)
Rash
6 (.56%)
Rectosigmoid Cancer
6 (.56%)
Abdominal Pain
5 (.47%)
Anuria
5 (.47%)
Blood Creatinine Increased
5 (.47%)
Cytolytic Hepatitis
5 (.47%)
General Physical Health Deteriorati...
5 (.47%)
Loss Of Consciousness
5 (.47%)
Paraesthesia
5 (.47%)
Pyrexia
5 (.47%)
Speech Disorder
5 (.47%)
Toxic Skin Eruption
5 (.47%)
Agranulocytosis
4 (.37%)
Alanine Aminotransferase Increased
4 (.37%)
Arrhythmia
4 (.37%)
Blood Alkaline Phosphatase Increase...
4 (.37%)
Bradycardia
4 (.37%)
Cardiac Failure
4 (.37%)
Coma
4 (.37%)
Cutaneous Vasculitis
4 (.37%)
Dizziness
4 (.37%)
Eosinophilia
4 (.37%)
Fatigue
4 (.37%)
Gamma-glutamyltransferase Increased
4 (.37%)
Gastrointestinal Disorder
4 (.37%)
Memory Impairment
4 (.37%)
Myelodysplastic Syndrome
4 (.37%)
Neuropathy Peripheral
4 (.37%)
Neutropenia
4 (.37%)
Orthostatic Hypotension
4 (.37%)
Psoriasis
4 (.37%)
Renal Failure Chronic
4 (.37%)
Respiratory Failure
4 (.37%)
Syncope
4 (.37%)
Thrombocytopenia
4 (.37%)
Urinary Tract Infection
4 (.37%)
Visual Acuity Reduced
4 (.37%)
Acidosis
3 (.28%)
Amnesia
3 (.28%)
Anaphylactic Shock
3 (.28%)
Aphasia
3 (.28%)
Autoimmune Hepatitis
3 (.28%)
Blindness Transient
3 (.28%)
Blood Pressure Decreased
3 (.28%)
Caesarean Section
3 (.28%)
Cardiac Arrest
3 (.28%)
Cardiac Disorder
3 (.28%)
Convulsion
3 (.28%)
Death
3 (.28%)
Decreased Appetite
3 (.28%)
Depression
3 (.28%)
Dermatitis Exfoliative
3 (.28%)
Disorientation
3 (.28%)
Drug Ineffective
3 (.28%)
Drug Rash With Eosinophilia And Sys...
3 (.28%)
Dyspepsia
3 (.28%)
Eating Disorder
3 (.28%)
Eczema
3 (.28%)
Gastroenteritis
3 (.28%)
Haemodialysis
3 (.28%)

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

What are the most common Aprovel Tabs adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Aprovel Tabs, 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 Aprovel Tabs 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 Aprovel Tabs According to Those Reporting Adverse Events

Why are people taking Aprovel Tabs, according to those reporting adverse events to the FDA?

Hypertension
179
Essential Hypertension
12
Blood Pressure Management
3
Diabetic Nephropathy
3
Renal Failure Chronic
3
Ischaemic Cardiomyopathy
2
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Cardiac Failure
2
Acquired Immunodeficiency Syndrome
2
Cardiac Disorder
2
Hypertensive Nephropathy
2
Myocardial Infarction
1
Infarction
1
Intermittent Claudication
1
Maternal Hypertension Affecting Foe...
1
Atrial Fibrillation
1
Blood Pressure
1
Diabetes Mellitus
1
Blood Pressure Increased
1

Aprovel Tabs Case Reports

What Aprovel Tabs 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 Aprovel Tabs. 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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