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Benicar Adverse Events Reported to the FDA Over Time

How are Benicar adverse event reports trending over time?

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

Most Common Benicar Adverse Events Reported to the FDA

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

Hypotension
401 (2.16%)
Drug Ineffective
392 (2.11%)
Dizziness
376 (2.02%)
Blood Pressure Increased
301 (1.62%)
Diarrhoea
237 (1.28%)
Headache
225 (1.21%)
Renal Failure Acute
220 (1.18%)
Nausea
203 (1.09%)
Oedema Peripheral
185 (1%)
Dehydration
178 (.96%)
Dyspnoea
178 (.96%)
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Weight Decreased
175 (.94%)
Vomiting
168 (.9%)
Malaise
165 (.89%)
Fall
164 (.88%)
Blood Pressure Decreased
161 (.87%)
Hyperkalaemia
157 (.84%)
Asthenia
154 (.83%)
Fatigue
144 (.77%)
Hypertension
136 (.73%)
Loss Of Consciousness
127 (.68%)
Syncope
125 (.67%)
Drug Interaction
123 (.66%)
Condition Aggravated
117 (.63%)
Cough
115 (.62%)
Hyponatraemia
109 (.59%)
Chest Pain
104 (.56%)
Renal Failure
101 (.54%)
Renal Impairment
100 (.54%)
Pain In Extremity
99 (.53%)
Blood Pressure Systolic Increased
91 (.49%)
Overdose
85 (.46%)
Pruritus
85 (.46%)
Feeling Abnormal
84 (.45%)
Rash
84 (.45%)
Cerebrovascular Accident
82 (.44%)
Anaemia
79 (.43%)
Bradycardia
78 (.42%)
Palpitations
76 (.41%)
Hypoglycaemia
73 (.39%)
Blood Creatinine Increased
71 (.38%)
Insomnia
70 (.38%)
Death
69 (.37%)
Coeliac Disease
65 (.35%)
Angina Pectoris
64 (.34%)
Muscle Spasms
64 (.34%)
Somnolence
64 (.34%)
Atrial Fibrillation
62 (.33%)
Blood Pressure Fluctuation
62 (.33%)
Pneumonia
62 (.33%)
Abdominal Pain
61 (.33%)
Anxiety
61 (.33%)
Depression
61 (.33%)
Arthralgia
60 (.32%)
Hyperhidrosis
60 (.32%)
Pain
60 (.32%)
Platelet Count Decreased
60 (.32%)
Alopecia
59 (.32%)
Hypertensive Emergency
59 (.32%)
Myalgia
59 (.32%)
Shock
58 (.31%)
Weight Increased
58 (.31%)
Drug Administration Error
57 (.31%)
Liver Disorder
57 (.31%)
Angioedema
55 (.3%)
Blood Glucose Increased
55 (.3%)
Hypersensitivity
54 (.29%)
Pyrexia
54 (.29%)
Back Pain
53 (.29%)
Heart Rate Increased
52 (.28%)
Abdominal Pain Upper
51 (.27%)
Tachycardia
51 (.27%)
Drug Exposure During Pregnancy
50 (.27%)
Hypoaesthesia
50 (.27%)
Hypokalaemia
50 (.27%)
Interstitial Lung Disease
50 (.27%)
Myocardial Infarction
50 (.27%)
Paraesthesia
50 (.27%)
Alanine Aminotransferase Increased
48 (.26%)
Completed Suicide
48 (.26%)
Decreased Appetite
47 (.25%)
Aspartate Aminotransferase Increase...
46 (.25%)
Urinary Tract Infection
46 (.25%)
Thrombocytopenia
45 (.24%)
Vision Blurred
45 (.24%)
Heart Rate Decreased
44 (.24%)
Convulsion
43 (.23%)
Cardiac Arrest
42 (.23%)
Oligohydramnios
42 (.23%)
Orthostatic Hypotension
42 (.23%)
Treatment Noncompliance
42 (.23%)
Arrhythmia
41 (.22%)
Blood Potassium Increased
41 (.22%)
Caesarean Section
41 (.22%)
Cardio-respiratory Arrest
41 (.22%)
Drug Eruption
41 (.22%)
Dry Mouth
41 (.22%)
Renal Disorder
40 (.22%)
Tremor
40 (.22%)
Blood Urea Increased
39 (.21%)
Cardiac Failure
39 (.21%)

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

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

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

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

Hypertension
5985
Product Used For Unknown Indication
981
Drug Use For Unknown Indication
935
Essential Hypertension
344
Blood Pressure
332
Blood Pressure Increased
70
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Blood Pressure Abnormal
62
Cardiac Disorder
46
Diabetes Mellitus
20
Blood Pressure Management
17
Prophylaxis
15
Blood Cholesterol Increased
12
Cardiac Failure Congestive
12
Diabetic Nephropathy
11
Myocardial Ischaemia
10
Ill-defined Disorder
9
Type 2 Diabetes Mellitus
9
Proteinuria
8
Fluid Retention
7
Coronary Artery Disease
7
Rheumatoid Arthritis
6
Suicide Attempt
6
Gestational Hypertension
6
Drug Exposure During Pregnancy
5
Blood Cholesterol
5
Hyperlipidaemia
5
Renal Hypertension
5
Renal Failure Chronic
5
Protein Urine
5
Atrial Fibrillation
5
Cardiomyopathy
5
Lyme Disease
4
Renal Disorder
4
Hypotension
4
Portal Hypertension
3
Oedema Peripheral
3
Cardiovascular Event Prophylaxis
3
Myocardial Infarction
3
Fibromyalgia
3
Cardiac Failure
3
Factor V Deficiency
3
Tachycardia
3
Cardiorenal Syndrome
3
Diabetes Mellitus Non-insulin-depen...
3
Glomerulonephritis Proliferative
2
Autoimmune Disorder
2
Transient Ischaemic Attack
2
Diuretic Therapy
2
Essential Tremor
2
Systolic Hypertension
2
Arrhythmia
2

Drug Labels

LabelLabelerEffective
BenicarPhysicians Total Care, Inc.20-MAY-10
Benicar HctPhysicians Total Care, Inc.30-NOV-10
BenicarLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-FEB-12
BenicarLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-FEB-12
Benicar Hct Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-FEB-12
Benicar HctPD-Rx Pharmaceuticals, Inc.05-MAR-12
Benicar PD-Rx Pharmaceuticals, Inc.25-APR-12
BenicarCardinal Health24-SEP-12
BenicarDaiichi Sankyo, Inc12-NOV-12
BenicarMed-Health Pharma, LLC12-NOV-12
Benicar HctDaiichi Sankyo, Inc.30-NOV-12
BenicarBryant Ranch Prepack18-JAN-13
BenicarBryant Ranch Prepack18-JAN-13
Benicar HctCardinal Health08-MAR-13

Benicar Case Reports

What Benicar 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 Benicar. 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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