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AGGRENOX

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Aggrenox Adverse Events Reported to the FDA Over Time

How are Aggrenox adverse event reports trending over time?

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

Most Common Aggrenox Adverse Events Reported to the FDA

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

Headache
402 (6.57%)
Nausea
212 (3.46%)
Cerebrovascular Accident
179 (2.92%)
Vomiting
137 (2.24%)
Dizziness
132 (2.16%)
Diarrhoea
123 (2.01%)
Transient Ischaemic Attack
101 (1.65%)
Fatigue
76 (1.24%)
Asthenia
69 (1.13%)
Cerebral Haemorrhage
61 (1%)
Renal Failure Acute
59 (.96%)
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Pain In Extremity
52 (.85%)
Abdominal Pain Upper
51 (.83%)
Gastrointestinal Haemorrhage
49 (.8%)
Malaise
49 (.8%)
Chest Pain
48 (.78%)
Dyspnoea
41 (.67%)
Hypotension
40 (.65%)
Feeling Abnormal
39 (.64%)
Loss Of Consciousness
38 (.62%)
Rash
37 (.6%)
Renal Failure
37 (.6%)
Back Pain
35 (.57%)
Fall
34 (.56%)
Hypertension
32 (.52%)
Myalgia
32 (.52%)
Myocardial Infarction
31 (.51%)
Abdominal Pain
29 (.47%)
Anaemia
29 (.47%)
Haemorrhage
29 (.47%)
Dyspepsia
28 (.46%)
Muscle Spasms
28 (.46%)
Abdominal Discomfort
27 (.44%)
Blood Pressure Increased
27 (.44%)
Dehydration
27 (.44%)
Gastrooesophageal Reflux Disease
27 (.44%)
Contusion
26 (.42%)
Epistaxis
26 (.42%)
Hypoaesthesia
26 (.42%)
Arthralgia
25 (.41%)
Memory Impairment
24 (.39%)
Muscular Weakness
24 (.39%)
Blood Glucose Increased
23 (.38%)
Cerebral Infarction
23 (.38%)
Duodenal Ulcer
23 (.38%)
Dysphagia
23 (.38%)
Pruritus
23 (.38%)
Subdural Haematoma
23 (.38%)
Thrombocytopenia
23 (.38%)
Urinary Tract Infection
23 (.38%)
Oedema Peripheral
22 (.36%)
Atrial Fibrillation
21 (.34%)
Cardiac Disorder
21 (.34%)
Death
21 (.34%)
Decreased Appetite
21 (.34%)
Gait Disturbance
21 (.34%)
Haemoglobin Decreased
21 (.34%)
Haemorrhage Intracranial
21 (.34%)
Hyperhidrosis
21 (.34%)
Rectal Haemorrhage
21 (.34%)
Weight Decreased
21 (.34%)
Somnolence
20 (.33%)
Syncope
20 (.33%)
Convulsion
19 (.31%)
Head Injury
19 (.31%)
Insomnia
19 (.31%)
Constipation
18 (.29%)
Drug Ineffective
18 (.29%)
Dysarthria
18 (.29%)
Pain
18 (.29%)
Paraesthesia
18 (.29%)
Sepsis
18 (.29%)
Tinnitus
18 (.29%)
Amnesia
17 (.28%)
Anxiety
17 (.28%)
Balance Disorder
17 (.28%)
Confusional State
17 (.28%)
Overdose
17 (.28%)
Pyrexia
17 (.28%)
Ageusia
16 (.26%)
Cough
16 (.26%)
Haematemesis
16 (.26%)
Hypersensitivity
16 (.26%)
Renal Failure Chronic
16 (.26%)
Suicide Attempt
16 (.26%)
Blood Pressure Decreased
15 (.24%)
Condition Aggravated
15 (.24%)
Dysgeusia
15 (.24%)
Dysphonia
15 (.24%)
Influenza Like Illness
15 (.24%)
Orthostatic Hypotension
15 (.24%)
Retching
15 (.24%)
Alopecia
14 (.23%)
Diverticulum
14 (.23%)
Gastritis Erosive
14 (.23%)
Hemiparesis
14 (.23%)
Hypoglycaemia
14 (.23%)
Metabolic Acidosis
14 (.23%)
Neck Pain
14 (.23%)
Night Sweats
14 (.23%)
Alanine Aminotransferase Increased
13 (.21%)

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

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

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

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

Cerebrovascular Accident Prophylaxi...
569
Transient Ischaemic Attack
424
Cerebrovascular Accident
318
Prophylaxis
116
Product Used For Unknown Indication
81
Drug Use For Unknown Indication
81
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Anticoagulant Therapy
71
Thrombosis Prophylaxis
25
Antiplatelet Therapy
24
Carotid Artery Occlusion
14
Ischaemic Stroke
14
Hypertension
12
Ischaemic Cerebral Infarction
11
Atrial Fibrillation
11
Coronary Artery Disease
9
Vascular Shunt
7
Arterial Disorder
7
Thrombosis
7
Cerebral Infarction
7
Cerebral Ischaemia
6
Lacunar Infarction
6
Angiopathy
5
Ischaemic Heart Disease Prophylaxis
5
Cardiac Disorder
5
Platelet Aggregation Abnormal
5
Cardiovascular Disorder
4
Cardiovascular Event Prophylaxis
4
Cerebrovascular Insufficiency
4
Cerebrovascular Disorder
4
Hypoaesthesia Facial
3
Coagulopathy
3
Hyperhomocysteinaemia
3
Reversible Ischaemic Neurological D...
3
Carotid Artery Stenosis
3
Hemiparesis
3
Dizziness
3
Epilepsy
3
Blood Disorder
2
Angina Pectoris
2
Cerebellar Infarction
2
Blood Pressure
2
Peripheral Arterial Occlusive Disea...
2
Migraine
2
Phlebitis Superficial
2
Enzyme Abnormality
2
Varicose Vein
2
Cerebral Haemorrhage
2
Post Procedural Stroke
2
Vascular Calcification
2
Cerebral Thrombosis
2
Artery Dissection
2

Drug Labels

LabelLabelerEffective
AggrenoxRebel Distributors Corp.01-SEP-10
AggrenoxPhysicians Total Care, Inc.16-APR-12
AggrenoxBoehringer Ingelheim Pharmaceuticals, Inc.18-SEP-12

Aggrenox Case Reports

What Aggrenox 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 Aggrenox. 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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