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Aprovel Adverse Events Reported to the FDA Over Time

How are Aprovel adverse event reports trending over time?

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

Most Common Aprovel Adverse Events Reported to the FDA

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

Renal Failure Acute
107 (3.94%)
Hyponatraemia
69 (2.54%)
Hyperkalaemia
54 (1.99%)
Renal Failure
49 (1.8%)
Fall
42 (1.55%)
Diarrhoea
39 (1.43%)
Anaemia
35 (1.29%)
Confusional State
34 (1.25%)
Hypotension
34 (1.25%)
Dehydration
33 (1.21%)
Asthenia
29 (1.07%)
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Lactic Acidosis
27 (.99%)
Blood Creatine Phosphokinase Increa...
26 (.96%)
Nausea
26 (.96%)
Blood Creatinine Increased
25 (.92%)
Drug Interaction
25 (.92%)
Malaise
24 (.88%)
Vomiting
23 (.85%)
Hypoglycaemia
22 (.81%)
Rhabdomyolysis
20 (.74%)
Metabolic Acidosis
19 (.7%)
Pyrexia
18 (.66%)
Dyspnoea
17 (.63%)
Hepatitis
17 (.63%)
Vertigo
17 (.63%)
Cytolytic Hepatitis
16 (.59%)
General Physical Health Deteriorati...
15 (.55%)
Loss Of Consciousness
15 (.55%)
Anorexia
14 (.52%)
Hyperhidrosis
14 (.52%)
Myalgia
14 (.52%)
Renal Impairment
14 (.52%)
Thrombocytopenia
14 (.52%)
Aspartate Aminotransferase Increase...
13 (.48%)
Bradycardia
13 (.48%)
Deep Vein Thrombosis
13 (.48%)
Overdose
13 (.48%)
Pruritus
13 (.48%)
Septic Shock
13 (.48%)
Visual Acuity Reduced
13 (.48%)
Convulsion
12 (.44%)
Dermatitis Exfoliative
12 (.44%)
Hypertension
12 (.44%)
Interstitial Lung Disease
12 (.44%)
Jaundice
12 (.44%)
Memory Impairment
12 (.44%)
Alanine Aminotransferase Increased
11 (.4%)
Drug Exposure During Pregnancy
11 (.4%)
Orthostatic Hypotension
11 (.4%)
Abortion Induced
10 (.37%)
Blood Alkaline Phosphatase Increase...
10 (.37%)
Cholestasis
10 (.37%)
Cough
10 (.37%)
Dizziness
10 (.37%)
Hypersensitivity
10 (.37%)
Neutropenia
10 (.37%)
Oedema Peripheral
10 (.37%)
Pancreatitis Acute
10 (.37%)
Weight Decreased
10 (.37%)
Abdominal Pain
9 (.33%)
Cataract
9 (.33%)
Depressed Level Of Consciousness
9 (.33%)
Gamma-glutamyltransferase Increased
9 (.33%)
Haemodialysis
9 (.33%)
Myelodysplastic Syndrome
9 (.33%)
Urinary Retention
9 (.33%)
Urinary Tract Infection
9 (.33%)
Anaphylactic Shock
8 (.29%)
Blood Pressure Increased
8 (.29%)
Cardiac Failure
8 (.29%)
Feeling Abnormal
8 (.29%)
Gastroenteritis
8 (.29%)
Hallucination
8 (.29%)
Hypovolaemia
8 (.29%)
Metastases To Liver
8 (.29%)
Myocardial Infarction
8 (.29%)
Pancytopenia
8 (.29%)
Pregnancy
8 (.29%)
Psoriasis
8 (.29%)
Rash
8 (.29%)
Syncope
8 (.29%)
Cardio-respiratory Arrest
7 (.26%)
Chest Pain
7 (.26%)
Disorientation
7 (.26%)
Erythema
7 (.26%)
Gastrointestinal Haemorrhage
7 (.26%)
Hallucination, Auditory
7 (.26%)
Hypokalaemia
7 (.26%)
Pain In Extremity
7 (.26%)
Anuria
6 (.22%)
Arrhythmia
6 (.22%)
Blood Pressure Decreased
6 (.22%)
Cardiac Arrest
6 (.22%)
Cerebrovascular Accident
6 (.22%)
Death
6 (.22%)
Decreased Appetite
6 (.22%)
Drug Ineffective
6 (.22%)
Dysstasia
6 (.22%)
Eczema
6 (.22%)
Eosinophilia
6 (.22%)
Fatigue
6 (.22%)

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

What are the most common Aprovel 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, 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 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 According to Those Reporting Adverse Events

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

Hypertension
627
Drug Use For Unknown Indication
101
Essential Hypertension
67
Product Used For Unknown Indication
35
Blood Pressure
18
Cardiac Disorder
5
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Blood Pressure Increased
5
Ill-defined Disorder
4
Unevaluable Event
4
Cardiac Failure
4
Coronary Artery Disease
4
Renal Failure Chronic
3
Diabetic Nephropathy
3
Hypertensive Heart Disease
3
Proteinuria
3
Diabetes Mellitus
3
Blood Pressure Management
3
Hypertensive Nephropathy
2
Myocardial Ischaemia
2
Malignant Hypertension
2
Ischaemic Cardiomyopathy
2
Breast Cancer
2
Myocardial Infarction
2
Acquired Immunodeficiency Syndrome
2
Renal Disorder
2
Secondary Hypertension
2
Atrial Fibrillation
2
Hypercholesterolaemia
1
Retinopathy
1
Pulmonary Hypertension
1
Maternal Hypertension Affecting Foe...
1
Nephropathy
1
Angina Pectoris
1
Renal Pain
1
Renal Hypertension
1
Infarction
1
Oedema
1
Intermittent Claudication
1
Prophylaxis
1
Hypertonia
1
Tinnitus
1
Systemic Lupus Erythematosus
1

Aprovel Case Reports

What Aprovel 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. 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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