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CAPTOPRIL

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Captopril Adverse Events Reported to the FDA Over Time

How are Captopril adverse event reports trending over time?

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

Most Common Captopril Adverse Events Reported to the FDA

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

Hypertension
53 (1.72%)
Renal Failure Acute
53 (1.72%)
Dyspnoea
44 (1.43%)
Asthenia
41 (1.33%)
Drug Ineffective
41 (1.33%)
Cough
34 (1.1%)
Hypotension
33 (1.07%)
Oedema Peripheral
33 (1.07%)
Drug Interaction
31 (1.01%)
Nausea
31 (1.01%)
Vomiting
31 (1.01%)
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Blood Creatinine Increased
28 (.91%)
Dizziness
28 (.91%)
Fatigue
24 (.78%)
Angioedema
23 (.75%)
Hyperkalaemia
23 (.75%)
Malaise
23 (.75%)
Blood Glucose Increased
22 (.71%)
Headache
22 (.71%)
Hypoglycaemia
21 (.68%)
Blood Pressure Increased
20 (.65%)
Renal Failure
20 (.65%)
Diarrhoea
19 (.62%)
Loss Of Consciousness
19 (.62%)
Pyrexia
19 (.62%)
Renal Impairment
19 (.62%)
Blood Urea Increased
17 (.55%)
Cardiac Failure
17 (.55%)
Fall
17 (.55%)
Overdose
17 (.55%)
Blood Potassium Increased
15 (.49%)
Blood Pressure Decreased
15 (.49%)
Bradycardia
15 (.49%)
Condition Aggravated
15 (.49%)
Dehydration
15 (.49%)
Metabolic Acidosis
15 (.49%)
Arrhythmia
14 (.45%)
Blood Pressure Inadequately Control...
14 (.45%)
Death
14 (.45%)
Hepatomegaly
13 (.42%)
Somnolence
13 (.42%)
Thrombotic Thrombocytopenic Purpura
13 (.42%)
C-reactive Protein Increased
12 (.39%)
Chest Pain
12 (.39%)
Confusional State
12 (.39%)
General Physical Health Deteriorati...
12 (.39%)
Hepatitis Cholestatic
12 (.39%)
Lactic Acidosis
12 (.39%)
Medication Error
12 (.39%)
Pruritus
12 (.39%)
Abdominal Pain
11 (.36%)
Blood Pressure Systolic Increased
11 (.36%)
Disease Progression
11 (.36%)
Dyskinesia
11 (.36%)
Heart Rate Increased
11 (.36%)
Hyponatraemia
11 (.36%)
Anaemia
10 (.32%)
Circulatory Collapse
10 (.32%)
Decreased Appetite
10 (.32%)
Drug Toxicity
10 (.32%)
Inflammation
10 (.32%)
Neutropenia
10 (.32%)
Syncope
10 (.32%)
Thrombocytopenia
10 (.32%)
Agranulocytosis
9 (.29%)
Atrial Fibrillation
9 (.29%)
Blood Cholesterol Increased
9 (.29%)
Blood Pressure Abnormal
9 (.29%)
Cerebrovascular Accident
9 (.29%)
Cytolytic Hepatitis
9 (.29%)
Dialysis
9 (.29%)
Erythema
9 (.29%)
International Normalised Ratio Incr...
9 (.29%)
Liver Disorder
9 (.29%)
Orthostatic Hypotension
9 (.29%)
Pneumonia
9 (.29%)
Psychomotor Retardation
9 (.29%)
Tachycardia
9 (.29%)
Urticaria
9 (.29%)
Ventricular Fibrillation
9 (.29%)
Ventricular Tachycardia
9 (.29%)
White Blood Cell Count Increased
9 (.29%)
Atrioventricular Block
8 (.26%)
Depression
8 (.26%)
Diabetes Mellitus
8 (.26%)
Disorientation
8 (.26%)
Drug Hypersensitivity
8 (.26%)
Hepatocellular Injury
8 (.26%)
Hyperhidrosis
8 (.26%)
Infection
8 (.26%)
Nodal Rhythm
8 (.26%)
Sinus Bradycardia
8 (.26%)
Balance Disorder
7 (.23%)
Blister
7 (.23%)
Cholestasis
7 (.23%)
Cushingoid
7 (.23%)
Diastolic Dysfunction
7 (.23%)
Disturbance In Attention
7 (.23%)
Drug Dispensing Error
7 (.23%)
Dysphagia
7 (.23%)
Feeling Abnormal
7 (.23%)

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

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

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

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

Hypertension
1389
Drug Use For Unknown Indication
260
Product Used For Unknown Indication
206
Blood Pressure
129
Cardiac Disorder
45
Blood Pressure Increased
43
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Essential Hypertension
31
Cardiac Failure
29
Cardiac Failure Congestive
25
Blood Pressure Abnormal
21
Ill-defined Disorder
17
Blood Pressure Management
15
Acute Myocardial Infarction
12
Coronary Artery Disease
11
Pulmonary Hypertension
9
Cardiomyopathy
8
Myocardial Infarction
6
Renal Disorder
5
Renal Failure
5
Myocardial Ischaemia
5
Cardiovascular Disorder
4
Diabetes Mellitus
4
Cerebrovascular Accident
3
Bronchopulmonary Dysplasia
3
Anticoagulant Therapy
3
Angina Pectoris
3
Oedema
3
Systolic Hypertension
3
Prophylaxis
2
Ventricular Extrasystoles
2
Aortic Valve Incompetence
2
Focal Glomerulosclerosis
2
Cardiomegaly
2
Atrial Fibrillation
2
Blood Pressure Inadequately Control...
2
Double Outlet Right Ventricle
2
Renal Impairment
2
Cardiac Operation
2
Nephrotic Syndrome
2
Chest Pain
2
Type 2 Diabetes Mellitus
2
Dementia
2
Blood Cholesterol
2
Protein Urine
2
Heart Disease Congenital
2
Malignant Hypertension
2
Hypertensive Crisis
2
Aortic Valve Replacement
2
Pericardial Effusion
2
Orthostatic Hypotension
2
Scleroderma
1

Drug Labels

LabelLabelerEffective
CaptoprilPD-Rx Pharmaceuticals, Inc.30-JUN-04
Captopril And HydrochlorothiazideMylan Phamaceuticals Inc.15-MAR-06
Captopril Apotex Corp.13-OCT-09
CaptoprilState of Florida DOH Central Pharmacy19-MAY-10
CaptoprilState of Florida DOH Central Pharmacy19-MAY-10
CaptoprilNCS HealthCare of KY, Inc dba Vangard Labs06-JUL-10
Captopril And HydrochlorothiazidePhysicians Total Care, Inc.02-DEC-10
CaptoprilRebel Distributors Corp10-DEC-10
CaptoprilUDL Laboratories, Inc.18-MAR-11
CaptoprilLegacy Pharmaceutical Packaging12-APR-11
CaptoprilREMEDYREPACK INC. 16-JUN-11
CaptoprilPD-Rx Pharmaceuticals, Inc.02-AUG-11
CaptoprilRedPharm Drug Inc.15-AUG-11
CaptoprilRedPharm Drug Inc.15-AUG-11
CaptoprilGolden State Medical Supply, Inc.09-JAN-12
CaptoprilPreferred Pharmaceuticals, Inc29-MAR-12
CaptoprilWockhardt Limited20-JUL-12
CaptoprilUnit Dose Services20-JUL-12
CaptoprilWockhardt USA LLC.20-JUL-12
Captopril And HydrochlorothiazideTeva Pharmaceuticals USA Inc13-AUG-12
CaptoprilWest-ward Pharmaceutical Corp05-SEP-12
CaptoprilUnit Dose Services05-SEP-12
CaptoprilUnit Dose Services05-SEP-12
CaptoprilMylan Pharmaceuticals Inc.30-SEP-12
CaptoprilPhysicians Total Care, Inc.01-OCT-12
CaptoprilBryant Ranch Prepack12-OCT-12
CaptoprilMajor Pharmaceuticals25-OCT-12
CaptoprilRebel Distributors Corp30-OCT-12
CaptoprilCardinal Health09-NOV-12
CaptoprilPreferred Pharmaceuticals, Inc.13-DEC-12
CaptoprilBryant Ranch Prepack17-JAN-13
CaptoprilBryant Ranch Prepack18-JAN-13
CaptoprilBryant Ranch Prepack18-JAN-13
CaptoprilREMEDYREPACK INC. 28-FEB-13
CaptoprilCardinal Health13-MAR-13
CaptoprilApotex Corp.23-APR-13

Captopril Case Reports

What Captopril 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 Captopril. 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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