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Vasotec Adverse Events Reported to the FDA Over Time

How are Vasotec adverse event reports trending over time?

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

Most Common Vasotec Adverse Events Reported to the FDA

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

Renal Failure Acute
466 (2.34%)
Hyperkalaemia
359 (1.8%)
Hypotension
314 (1.58%)
Drug Interaction
286 (1.43%)
Dyspnoea
259 (1.3%)
Angioedema
222 (1.11%)
Cardiac Failure
220 (1.1%)
Diarrhoea
213 (1.07%)
Renal Failure
199 (1%)
Dehydration
198 (.99%)
Dizziness
185 (.93%)
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Vomiting
170 (.85%)
Blood Creatinine Increased
165 (.83%)
Nausea
164 (.82%)
Blood Pressure Increased
162 (.81%)
Hyponatraemia
161 (.81%)
Condition Aggravated
148 (.74%)
Fall
142 (.71%)
Malaise
134 (.67%)
Hypoglycaemia
128 (.64%)
Cough
127 (.64%)
Renal Impairment
124 (.62%)
Asthenia
123 (.62%)
Hypertension
118 (.59%)
Bradycardia
117 (.59%)
Drug Ineffective
114 (.57%)
Concomitant Disease Progression
113 (.57%)
Lactic Acidosis
112 (.56%)
Oedema Peripheral
112 (.56%)
Atrial Fibrillation
107 (.54%)
Headache
102 (.51%)
Syncope
101 (.51%)
Fatigue
99 (.5%)
Loss Of Consciousness
99 (.5%)
Chest Pain
95 (.48%)
Completed Suicide
94 (.47%)
Anaemia
93 (.47%)
Disease Progression
92 (.46%)
Blood Glucose Increased
87 (.44%)
Decreased Appetite
87 (.44%)
General Physical Health Deteriorati...
84 (.42%)
Blood Pressure Decreased
81 (.41%)
Abdominal Pain
80 (.4%)
Pneumonia
80 (.4%)
Pyrexia
79 (.4%)
Cardiac Arrest
77 (.39%)
Confusional State
73 (.37%)
Swollen Tongue
72 (.36%)
Metabolic Acidosis
70 (.35%)
Somnolence
70 (.35%)
Blood Pressure Inadequately Control...
69 (.35%)
Blood Urea Increased
69 (.35%)
Dialysis
69 (.35%)
Haemoglobin Decreased
68 (.34%)
Urinary Tract Infection
66 (.33%)
Rash
65 (.33%)
Drug Hypersensitivity
64 (.32%)
Haemodialysis
64 (.32%)
Hypokalaemia
59 (.3%)
Blood Potassium Increased
58 (.29%)
Cardiac Failure Congestive
58 (.29%)
Electrocardiogram Qrs Complex Prolo...
56 (.28%)
Orthostatic Hypotension
56 (.28%)
Tremor
56 (.28%)
Interstitial Lung Disease
55 (.28%)
Tachycardia
55 (.28%)
Alanine Aminotransferase Increased
53 (.27%)
Inappropriate Antidiuretic Hormone ...
52 (.26%)
Swelling Face
51 (.26%)
Drug Exposure During Pregnancy
50 (.25%)
Weight Decreased
50 (.25%)
Constipation
49 (.25%)
Hypersensitivity
49 (.25%)
Shock
48 (.24%)
Thrombocytopenia
48 (.24%)
Cardio-respiratory Arrest
47 (.24%)
Abdominal Pain Upper
46 (.23%)
Aspartate Aminotransferase Increase...
46 (.23%)
Depressed Level Of Consciousness
46 (.23%)
Depression
44 (.22%)
Toxic Epidermal Necrolysis
44 (.22%)
Pruritus
42 (.21%)
Arthralgia
41 (.21%)
Overdose
41 (.21%)
Pulmonary Oedema
41 (.21%)
Respiratory Failure
41 (.21%)
Renal Failure Chronic
40 (.2%)
Blood Sodium Decreased
39 (.2%)
Hyperhidrosis
39 (.2%)
Pain
39 (.2%)
Pain In Extremity
39 (.2%)
Palpitations
38 (.19%)
Sepsis
38 (.19%)
Urticaria
38 (.19%)
White Blood Cell Count Increased
38 (.19%)
International Normalised Ratio Incr...
37 (.19%)
Oedema
37 (.19%)
Ventricular Extrasystoles
37 (.19%)
Acute Respiratory Distress Syndrome
36 (.18%)
Arrhythmia
36 (.18%)
Lip Swelling
36 (.18%)

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

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

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

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

Hypertension
5178
Drug Use For Unknown Indication
1061
Product Used For Unknown Indication
881
Cardiac Failure
496
Blood Pressure
322
Essential Hypertension
180
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Cardiac Failure Chronic
158
Cardiac Disorder
110
Blood Pressure Increased
107
Cardiac Failure Congestive
83
Blood Pressure Abnormal
50
Ill-defined Disorder
50
Diabetes Mellitus
41
Prophylaxis
41
Myocardial Infarction
34
Coronary Artery Disease
32
Cardiomyopathy
32
Myocardial Ischaemia
25
Cardiovascular Disorder
24
Renal Failure
20
Atrial Fibrillation
19
Hypertonia
16
Proteinuria
14
Angina Pectoris
14
Angiopathy
14
Blood Pressure Management
13
Cardiovascular Event Prophylaxis
13
Renal Disorder
13
Microalbuminuria
9
Scleroderma Renal Crisis
8
Protein Urine
8
Acute Myocardial Infarction
8
Renovascular Hypertension
7
Suicide Attempt
7
Renal Hypertension
7
Completed Suicide
7
Secondary Hypertension
6
Blood Cholesterol
6
Nephropathy
6
Arrhythmia
6
Fluid Retention
5
Cerebrovascular Accident
5
Aortic Dissection
5
Angioplasty
5
Nephrotic Syndrome
5
Hypotension
4
Insomnia
4
Cerebral Haemorrhage
4
Migraine
4
Malignant Hypertension
4
Mitral Valve Prolapse
4

Drug Labels

LabelLabelerEffective
VasotecBTA Pharmaceuticals Inc.30-JUN-10
VasotecValeant Pharmaceuticals North America LLC13-SEP-12

Vasotec Case Reports

What Vasotec 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 Vasotec. 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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