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MICARDIS

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Micardis Adverse Events Reported to the FDA Over Time

How are Micardis adverse event reports trending over time?

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

Most Common Micardis Adverse Events Reported to the FDA

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

Dizziness
335 (1.91%)
Renal Failure Acute
269 (1.54%)
Renal Failure
241 (1.38%)
Blood Pressure Increased
232 (1.32%)
Hyperkalaemia
218 (1.24%)
Dyspnoea
202 (1.15%)
Cerebral Infarction
188 (1.07%)
Drug Ineffective
179 (1.02%)
Fatigue
176 (1%)
Hypotension
176 (1%)
Death
173 (.99%)
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Headache
172 (.98%)
Asthenia
170 (.97%)
Nausea
170 (.97%)
Hypertension
160 (.91%)
Cardiac Failure
159 (.91%)
Loss Of Consciousness
154 (.88%)
Interstitial Lung Disease
140 (.8%)
Oedema Peripheral
138 (.79%)
Blood Creatinine Increased
137 (.78%)
Rash
135 (.77%)
Pneumonia
134 (.77%)
Fall
132 (.75%)
Diarrhoea
130 (.74%)
Hypoglycaemia
129 (.74%)
Blood Pressure Inadequately Control...
125 (.71%)
Myalgia
121 (.69%)
Renal Failure Chronic
115 (.66%)
Back Pain
112 (.64%)
Renal Impairment
111 (.63%)
Pain In Extremity
110 (.63%)
Liver Disorder
107 (.61%)
Myocardial Infarction
106 (.61%)
Hepatic Function Abnormal
105 (.6%)
Dehydration
103 (.59%)
Malaise
101 (.58%)
Anaemia
98 (.56%)
Blood Pressure Decreased
97 (.55%)
Muscle Spasms
94 (.54%)
Pyrexia
94 (.54%)
Hyponatraemia
90 (.51%)
Cough
88 (.5%)
Chest Pain
87 (.5%)
Palpitations
87 (.5%)
Vomiting
87 (.5%)
Syncope
86 (.49%)
Pruritus
83 (.47%)
Weight Decreased
83 (.47%)
Atrial Fibrillation
82 (.47%)
Arthralgia
80 (.46%)
Feeling Abnormal
73 (.42%)
Jaundice
70 (.4%)
Blood Creatine Phosphokinase Increa...
69 (.39%)
Cerebrovascular Accident
69 (.39%)
Urinary Tract Infection
65 (.37%)
Haemodialysis
64 (.37%)
Suicide Attempt
63 (.36%)
Overdose
62 (.35%)
Transient Ischaemic Attack
61 (.35%)
Anorexia
60 (.34%)
Bradycardia
59 (.34%)
Vision Blurred
59 (.34%)
Angioedema
56 (.32%)
Hyperhidrosis
56 (.32%)
Abdominal Pain Upper
55 (.31%)
Rhabdomyolysis
55 (.31%)
Cardiac Failure Congestive
54 (.31%)
Alopecia
53 (.3%)
Pollakiuria
53 (.3%)
Sepsis
53 (.3%)
Cerebral Haemorrhage
52 (.3%)
Pain
52 (.3%)
Joint Swelling
51 (.29%)
Sudden Death
51 (.29%)
Condition Aggravated
50 (.29%)
Insomnia
49 (.28%)
Blood Glucose Increased
48 (.27%)
Dyspepsia
48 (.27%)
Thrombocytopenia
47 (.27%)
Alanine Aminotransferase Increased
46 (.26%)
Hepatitis Acute
46 (.26%)
Acute Myocardial Infarction
45 (.26%)
Diabetes Mellitus
45 (.26%)
Hypoaesthesia
45 (.26%)
Tremor
45 (.26%)
Confusional State
44 (.25%)
Blood Potassium Increased
43 (.25%)
Chest Discomfort
43 (.25%)
Angina Pectoris
42 (.24%)
Paraesthesia
42 (.24%)
Blood Urea Increased
41 (.23%)
Dialysis
41 (.23%)
Tachycardia
41 (.23%)
Aspartate Aminotransferase Increase...
40 (.23%)
Drug Interaction
40 (.23%)
Renal Disorder
40 (.23%)
Somnolence
39 (.22%)
Blood Alkaline Phosphatase Increase...
38 (.22%)
Heart Rate Increased
38 (.22%)
Abdominal Pain
37 (.21%)
Erythema
37 (.21%)

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

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

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

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

Hypertension
5920
Cerebrovascular Accident Prophylaxi...
349
Product Used For Unknown Indication
314
Drug Use For Unknown Indication
307
Essential Hypertension
193
Cardiovascular Disorder
190
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Blood Pressure
137
Prophylaxis
94
Myocardial Infarction
67
Blood Pressure Increased
59
Cardiac Disorder
41
Diabetic Nephropathy
37
Cerebrovascular Accident
35
Blood Pressure Abnormal
33
Cardiac Failure
16
Cardiac Failure Congestive
13
Diabetes Mellitus
10
Renal Hypertension
10
Coronary Artery Disease
9
Congenital Cystic Kidney Disease
9
Thrombosis Prophylaxis
9
Hypertonia
8
Acute Myocardial Infarction
8
Type 2 Diabetes Mellitus
8
Ill-defined Disorder
8
Blood Pressure Management
7
Cardiovascular Event Prophylaxis
6
Renal Disorder
6
Renal Failure Chronic
6
Atrial Fibrillation
5
Prophylaxis Against Transplant Reje...
5
Adverse Event
4
Drug Abuse
4
Cardiac Failure Chronic
4
Drug Exposure During Pregnancy
4
Chest Discomfort
4
Diuretic Therapy
3
Benign Prostatic Hyperplasia
3
Hypertensive Heart Disease
3
Nephropathy
3
Swelling
3
Congestive Cardiomyopathy
3
Tachycardia
3
Proteinuria
3
Renal Failure Acute
2
Nausea
2
Back Pain
2
Oedema Peripheral
2
Blood Pressure Fluctuation
2
Systolic Hypertension
2
Hypotension
2

Drug Labels

LabelLabelerEffective
MicardisPhysicians Total Care, Inc.14-FEB-12
Micardis HctPhysicians Total Care, Inc.14-FEB-12
Micardis HctLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-MAR-12
MicardisLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-MAR-12
MicardisBoehringer Ingelheim Pharmaceuticals, Inc.31-OCT-12
Micardis HctBoehringer Ingelheim Pharmaceuticals, Inc.31-OCT-12

Micardis Case Reports

What Micardis 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 Micardis. 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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