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OLMESARTAN MEDOXOMIL

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Olmesartan Medoxomil Adverse Events Reported to the FDA Over Time

How are Olmesartan Medoxomil adverse event reports trending over time?

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

Most Common Olmesartan Medoxomil Adverse Events Reported to the FDA

What are the most common Olmesartan Medoxomil adverse events reported to the FDA?

Hypotension
408 (2.13%)
Drug Ineffective
394 (2.05%)
Dizziness
390 (2.03%)
Blood Pressure Increased
308 (1.61%)
Diarrhoea
248 (1.29%)
Headache
233 (1.21%)
Renal Failure Acute
222 (1.16%)
Nausea
213 (1.11%)
Oedema Peripheral
209 (1.09%)
Dyspnoea
188 (.98%)
Dehydration
186 (.97%)
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Weight Decreased
185 (.96%)
Vomiting
176 (.92%)
Fall
171 (.89%)
Malaise
169 (.88%)
Blood Pressure Decreased
168 (.88%)
Asthenia
162 (.84%)
Hyperkalaemia
157 (.82%)
Fatigue
149 (.78%)
Hypertension
140 (.73%)
Loss Of Consciousness
132 (.69%)
Syncope
131 (.68%)
Drug Interaction
125 (.65%)
Condition Aggravated
120 (.63%)
Cough
120 (.63%)
Hyponatraemia
109 (.57%)
Chest Pain
107 (.56%)
Pain In Extremity
105 (.55%)
Renal Failure
105 (.55%)
Renal Impairment
105 (.55%)
Pruritus
94 (.49%)
Blood Pressure Systolic Increased
92 (.48%)
Feeling Abnormal
90 (.47%)
Rash
90 (.47%)
Cerebrovascular Accident
86 (.45%)
Overdose
85 (.44%)
Anaemia
84 (.44%)
Bradycardia
78 (.41%)
Palpitations
78 (.41%)
Blood Creatinine Increased
73 (.38%)
Hypoglycaemia
73 (.38%)
Death
71 (.37%)
Insomnia
70 (.36%)
Muscle Spasms
70 (.36%)
Coeliac Disease
69 (.36%)
Somnolence
66 (.34%)
Hyperhidrosis
65 (.34%)
Angina Pectoris
64 (.33%)
Blood Pressure Fluctuation
64 (.33%)
Pneumonia
64 (.33%)
Alopecia
63 (.33%)
Arthralgia
63 (.33%)
Depression
63 (.33%)
Abdominal Pain
62 (.32%)
Atrial Fibrillation
62 (.32%)
Myalgia
62 (.32%)
Pain
62 (.32%)
Anxiety
61 (.32%)
Blood Glucose Increased
61 (.32%)
Weight Increased
61 (.32%)
Drug Administration Error
60 (.31%)
Myocardial Infarction
60 (.31%)
Platelet Count Decreased
60 (.31%)
Back Pain
59 (.31%)
Hypersensitivity
59 (.31%)
Hypertensive Emergency
59 (.31%)
Shock
58 (.3%)
Heart Rate Increased
57 (.3%)
Liver Disorder
57 (.3%)
Pyrexia
57 (.3%)
Angioedema
55 (.29%)
Hypoaesthesia
54 (.28%)
Tachycardia
53 (.28%)
Abdominal Pain Upper
51 (.27%)
Paraesthesia
51 (.27%)
Drug Exposure During Pregnancy
50 (.26%)
Hypokalaemia
50 (.26%)
Interstitial Lung Disease
50 (.26%)
Decreased Appetite
49 (.26%)
Alanine Aminotransferase Increased
48 (.25%)
Completed Suicide
48 (.25%)
Urinary Tract Infection
47 (.24%)
Aspartate Aminotransferase Increase...
46 (.24%)
Convulsion
46 (.24%)
Vision Blurred
46 (.24%)
Thrombocytopenia
45 (.23%)
Dry Mouth
44 (.23%)
Heart Rate Decreased
44 (.23%)
Treatment Noncompliance
44 (.23%)
Tremor
44 (.23%)
Arrhythmia
43 (.22%)
Blood Potassium Increased
42 (.22%)
Cardiac Arrest
42 (.22%)
Oligohydramnios
42 (.22%)
Orthostatic Hypotension
42 (.22%)
Blood Pressure Inadequately Control...
41 (.21%)
Caesarean Section
41 (.21%)
Cardio-respiratory Arrest
41 (.21%)
Drug Eruption
41 (.21%)
Erythema
41 (.21%)
Renal Disorder
41 (.21%)

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

What are the most common Olmesartan Medoxomil adverse events reported to the FDA?

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

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

Hypertension
6242
Product Used For Unknown Indication
1084
Drug Use For Unknown Indication
993
Blood Pressure
353
Essential Hypertension
344
Blood Pressure Abnormal
74
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Blood Pressure Increased
72
Cardiac Disorder
47
Diabetes Mellitus
20
Blood Pressure Management
17
Prophylaxis
15
Cardiac Failure Congestive
13
Blood Cholesterol Increased
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
7
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

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BenicarPhysicians Total Care, Inc.20-MAY-10
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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 PD-Rx Pharmaceuticals, Inc.25-APR-12
BenicarCardinal Health24-SEP-12
BenicarDaiichi Sankyo, Inc12-NOV-12
TribenzorDaiichi Sankyo, Inc.12-NOV-12
AzorDaiichi Sankyo, Inc.12-NOV-12
BenicarMed-Health Pharma, LLC12-NOV-12
BenicarBryant Ranch Prepack18-JAN-13
BenicarBryant Ranch Prepack18-JAN-13

Olmesartan Medoxomil Case Reports

What Olmesartan Medoxomil 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 Olmesartan Medoxomil. 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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