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ENALAPRIL MALEATE

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Enalapril Maleate Adverse Events Reported to the FDA Over Time

How are Enalapril Maleate adverse event reports trending over time?

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

Most Common Enalapril Maleate Adverse Events Reported to the FDA

What are the most common Enalapril Maleate adverse events reported to the FDA?

Renal Failure Acute
500 (2.42%)
Hyperkalaemia
383 (1.85%)
Hypotension
320 (1.55%)
Drug Interaction
296 (1.43%)
Dyspnoea
264 (1.28%)
Angioedema
225 (1.09%)
Cardiac Failure
221 (1.07%)
Diarrhoea
220 (1.06%)
Renal Failure
210 (1.02%)
Dehydration
206 (1%)
Dizziness
193 (.93%)
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Vomiting
177 (.86%)
Hyponatraemia
174 (.84%)
Blood Creatinine Increased
171 (.83%)
Nausea
169 (.82%)
Blood Pressure Increased
168 (.81%)
Fall
152 (.74%)
Condition Aggravated
148 (.72%)
Malaise
134 (.65%)
Hypoglycaemia
133 (.64%)
Cough
131 (.63%)
Asthenia
128 (.62%)
Lactic Acidosis
125 (.6%)
Renal Impairment
125 (.6%)
Hypertension
122 (.59%)
Bradycardia
121 (.59%)
Drug Ineffective
115 (.56%)
Oedema Peripheral
114 (.55%)
Concomitant Disease Progression
113 (.55%)
Atrial Fibrillation
112 (.54%)
Syncope
109 (.53%)
Headache
105 (.51%)
Fatigue
102 (.49%)
Loss Of Consciousness
101 (.49%)
Chest Pain
98 (.47%)
Anaemia
94 (.45%)
Completed Suicide
94 (.45%)
Decreased Appetite
93 (.45%)
Disease Progression
92 (.45%)
Blood Glucose Increased
90 (.44%)
General Physical Health Deteriorati...
86 (.42%)
Blood Pressure Decreased
84 (.41%)
Pyrexia
83 (.4%)
Abdominal Pain
82 (.4%)
Confusional State
80 (.39%)
Pneumonia
80 (.39%)
Cardiac Arrest
79 (.38%)
Somnolence
75 (.36%)
Swollen Tongue
74 (.36%)
Metabolic Acidosis
73 (.35%)
Dialysis
72 (.35%)
Blood Urea Increased
71 (.34%)
Blood Pressure Inadequately Control...
69 (.33%)
Haemoglobin Decreased
69 (.33%)
Rash
69 (.33%)
Urinary Tract Infection
67 (.32%)
Haemodialysis
66 (.32%)
Drug Hypersensitivity
65 (.31%)
Hypokalaemia
65 (.31%)
Blood Potassium Increased
59 (.29%)
Cardiac Failure Congestive
58 (.28%)
Interstitial Lung Disease
57 (.28%)
Electrocardiogram Qrs Complex Prolo...
56 (.27%)
Orthostatic Hypotension
56 (.27%)
Tachycardia
56 (.27%)
Tremor
56 (.27%)
Alanine Aminotransferase Increased
54 (.26%)
Inappropriate Antidiuretic Hormone ...
54 (.26%)
Cardio-respiratory Arrest
52 (.25%)
Drug Exposure During Pregnancy
52 (.25%)
Weight Decreased
52 (.25%)
Swelling Face
51 (.25%)
Pruritus
50 (.24%)
Shock
50 (.24%)
Constipation
49 (.24%)
Hypersensitivity
49 (.24%)
Thrombocytopenia
49 (.24%)
Aspartate Aminotransferase Increase...
47 (.23%)
Depressed Level Of Consciousness
47 (.23%)
Abdominal Pain Upper
46 (.22%)
Depression
46 (.22%)
Toxic Epidermal Necrolysis
45 (.22%)
Overdose
42 (.2%)
Arthralgia
41 (.2%)
Blood Sodium Decreased
41 (.2%)
Pain
41 (.2%)
Pulmonary Oedema
41 (.2%)
Respiratory Failure
41 (.2%)
Palpitations
40 (.19%)
Renal Failure Chronic
40 (.19%)
Urticaria
40 (.19%)
Hyperhidrosis
39 (.19%)
Muscle Spasms
39 (.19%)
Oedema
39 (.19%)
Pain In Extremity
39 (.19%)
Medication Error
38 (.18%)
Sepsis
38 (.18%)
Ventricular Tachycardia
38 (.18%)
White Blood Cell Count Increased
38 (.18%)
Anorexia
37 (.18%)
Arrhythmia
37 (.18%)

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

What are the most common Enalapril Maleate adverse events reported to the FDA?

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

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

Hypertension
5480
Drug Use For Unknown Indication
1148
Product Used For Unknown Indication
899
Cardiac Failure
503
Blood Pressure
332
Essential Hypertension
200
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Cardiac Failure Chronic
158
Cardiac Disorder
110
Blood Pressure Increased
109
Cardiac Failure Congestive
85
Ill-defined Disorder
52
Blood Pressure Abnormal
51
Prophylaxis
41
Diabetes Mellitus
41
Myocardial Infarction
34
Coronary Artery Disease
33
Cardiomyopathy
32
Myocardial Ischaemia
27
Cardiovascular Disorder
25
Hypertonia
24
Atrial Fibrillation
21
Renal Failure
21
Proteinuria
16
Angina Pectoris
14
Angiopathy
14
Blood Pressure Management
13
Renal Disorder
13
Cardiovascular Event Prophylaxis
13
Microalbuminuria
9
Scleroderma Renal Crisis
8
Acute Myocardial Infarction
8
Protein Urine
8
Arrhythmia
8
Suicide Attempt
7
Renal Hypertension
7
Completed Suicide
7
Renovascular Hypertension
7
Blood Cholesterol
6
Secondary Hypertension
6
Nephropathy
6
Nephrotic Syndrome
5
Angioplasty
5
Aortic Dissection
5
Cerebrovascular Accident
5
Fluid Retention
5
Hypotension
4
Insomnia
4
Cerebral Haemorrhage
4
Diuretic Therapy
4
Migraine
4
Malignant Hypertension
4

Drug Labels

LabelLabelerEffective
Enalapril Maleate And HydrochlorothiazidePhysicians Total Care, Inc.20-NOV-09
Enalapril MaleateBryant Ranch Prepack11-DEC-09
Enalapril MaleateBryant Ranch Prepack11-DEC-09
Enalapril MaleateApace Packaging26-DEC-09
Enalapril Maleate And HydrochlorothiazideDr. Reddy's Laboratories Limited 17-FEB-10
Enalapril Maleate And HydrochlorothiazideBryant Ranch Prepack10-MAY-10
Enalapril MaleatePhysicians Total Care, Inc.17-MAY-10
Enalapril MaleateContract Pharmacy Services-PA28-JUN-10
VasotecBTA Pharmaceuticals Inc.30-JUN-10
Enalapril Maleate PD-Rx Pharmaceuticals, Inc.05-JUL-10
Enalapril Maleate PD-Rx Pharmaceuticals, Inc.05-JUL-10
Enalapril Maleate PD-Rx Pharmaceuticals, Inc.05-JUL-10
Enalapril MaleateWOCKHARDT USA LLC05-JUL-10
Enalapril MaleateMylan Pharmaceuticals Inc.01-AUG-10
Enalapril MaleateContract Pharmacy Services-PA02-AUG-10
Enalapril MaleateState of Florida DOH Central Pharmacy03-AUG-10
Enalapril MaleateState of Florida DOH Central Pharmacy18-AUG-10
Enalapril MaleateRebel Distributors Corp24-SEP-10
Enalapril Maleate And HydrochlorothiazideRebel Distributors Corp20-DEC-10
Enalapril MaleateMed Health Pharma, LLC01-JAN-11
Enalapril MaleateUDL Laboratories, Inc.07-JAN-11
Enalapril MaleateREMEDYREPACK INC. 08-APR-11
Enalapril MaleateAmerican Health Packaging13-APR-11
Enalapril Maleate And HydrochlorothiazideMylan Pharmaceuticals Inc.27-APR-11
Enalapril MaleateCardinal Health13-MAY-11
Enalapril MaleateREMEDYREPACK INC. 05-OCT-11
Enalapril MaleateREMEDYREPACK INC. 11-OCT-11
Enalapril MaleatePreferred Pharmaceuticals, Inc17-JAN-12
Enalapril MaleateWOCKHARDT LIMITED20-JAN-12
Enalapril MaleateTaro Pharmaceuticals U.S.A., Inc.12-JUN-12
Enalapril Maleate And HydrochlorothiazideTaro Pharmaceuticals U.S.A., Inc.29-JUN-12
Enalapril MaleateMajor Pharmaceuticals09-JUL-12
Enalapril Maleate STAT Rx USA LLC12-SEP-12
VasotecValeant Pharmaceuticals North America LLC13-SEP-12
VasereticValeant Pharmaceuticals North America LLC13-SEP-12
Enalapril Maleate And HydrochlorothiazideApotex Corp.01-OCT-12
Enalapril MaleateDispensing Solutions, Inc.02-OCT-12
Enalapril MaleateREMEDYREPACK INC. 03-OCT-12
Enalapril MaleateTeva Pharmaceuticals USA Inc18-OCT-12
Enalapril MaleateGolden State Medical Supply, Inc.03-JAN-13
Enalapril MaleateNCS HealthCare of KY, Inc dba Vangard Labs25-FEB-13
Enalapril Maleate And HydrochlorothiazideTeva Pharmaceuticals USA Inc07-MAR-13
Enalapril MaleateREMEDYREPACK INC. 11-MAR-13
Enalapril MaleateREMEDYREPACK INC. 14-MAR-13
Enalapril MaleateREMEDYREPACK INC. 15-MAR-13
Enalapril MaleateLegacy Pharmaceutical Packaging20-MAR-13
Enalapril MaleateREMEDYREPACK INC. 29-MAR-13
Enalapril MaleateApotex Corp.09-APR-13
Enalapril MaleateCardinal Health29-APR-13
Enalapril MaleateCardinal Health30-APR-13

Enalapril Maleate Case Reports

What Enalapril Maleate 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 Enalapril Maleate. 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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