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EXEMESTANE

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Exemestane Adverse Events Reported to the FDA Over Time

How are Exemestane adverse event reports trending over time?

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

Most Common Exemestane Adverse Events Reported to the FDA

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

Pulmonary Embolism
72 (3.49%)
Arthralgia
43 (2.09%)
Vomiting
25 (1.21%)
Diarrhoea
24 (1.16%)
Fall
24 (1.16%)
Hepatic Failure
23 (1.12%)
Cerebrovascular Accident
22 (1.07%)
Dyspnoea
22 (1.07%)
Malaise
22 (1.07%)
Hypertension
21 (1.02%)
Nausea
21 (1.02%)
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Deep Vein Thrombosis
20 (.97%)
Fatigue
20 (.97%)
Condition Aggravated
19 (.92%)
Drug Interaction
18 (.87%)
Hot Flush
18 (.87%)
Asthenia
17 (.82%)
Confusional State
17 (.82%)
Diabetes Mellitus
17 (.82%)
Hepatic Function Abnormal
17 (.82%)
Hyponatraemia
17 (.82%)
Osteopenia
17 (.82%)
Death
16 (.78%)
Depression
16 (.78%)
Atrial Fibrillation
15 (.73%)
Headache
15 (.73%)
Dizziness
14 (.68%)
Sensory Loss
14 (.68%)
Urinary Tract Infection
14 (.68%)
Febrile Neutropenia
13 (.63%)
Pain In Extremity
13 (.63%)
Cardiac Failure Congestive
12 (.58%)
Cerebral Haemorrhage
12 (.58%)
Fracture
12 (.58%)
Osteonecrosis
12 (.58%)
Dehydration
11 (.53%)
Haemoglobin Decreased
11 (.53%)
Oedema Peripheral
11 (.53%)
Renal Failure
11 (.53%)
Subdural Haematoma
11 (.53%)
Syncope
11 (.53%)
Cellulitis
10 (.48%)
Feeling Abnormal
10 (.48%)
Hepatic Cirrhosis
10 (.48%)
Hypercholesterolaemia
10 (.48%)
Insomnia
10 (.48%)
Liver Function Test Abnormal
10 (.48%)
Pain
10 (.48%)
Sepsis
10 (.48%)
Aphasia
9 (.44%)
Bone Pain
9 (.44%)
Cerebral Ischaemia
9 (.44%)
Myalgia
9 (.44%)
Transient Ischaemic Attack
9 (.44%)
Weight Decreased
9 (.44%)
Bronchopneumonia
8 (.39%)
Chest Pain
8 (.39%)
Hepatitis Cholestatic
8 (.39%)
Musculoskeletal Disorder
8 (.39%)
Neutrophil Count Decreased
8 (.39%)
Pyrexia
8 (.39%)
Abdominal Discomfort
7 (.34%)
Alopecia
7 (.34%)
Breast Cancer
7 (.34%)
Dysarthria
7 (.34%)
General Physical Health Deteriorati...
7 (.34%)
Hypercalcaemia
7 (.34%)
Melaena
7 (.34%)
Migraine
7 (.34%)
Muscle Spasms
7 (.34%)
Platelet Count Decreased
7 (.34%)
Pneumonia
7 (.34%)
Vertigo
7 (.34%)
Weight Increased
7 (.34%)
Alanine Aminotransferase Increased
6 (.29%)
Anaemia
6 (.29%)
Aspartate Aminotransferase Increase...
6 (.29%)
Grand Mal Convulsion
6 (.29%)
International Normalised Ratio Incr...
6 (.29%)
Joint Stiffness
6 (.29%)
Osteoporosis
6 (.29%)
Pancreatitis Acute
6 (.29%)
Pruritus
6 (.29%)
Traumatic Brain Injury
6 (.29%)
Abdominal Pain
5 (.24%)
Anxiety
5 (.24%)
Cardiac Arrest
5 (.24%)
Cardiac Cirrhosis
5 (.24%)
Carpal Tunnel Syndrome
5 (.24%)
Cataract
5 (.24%)
Chest Discomfort
5 (.24%)
Disease Progression
5 (.24%)
Drug Intolerance
5 (.24%)
Electrocardiogram Qt Prolonged
5 (.24%)
Erythema Multiforme
5 (.24%)
Gait Disturbance
5 (.24%)
Haematemesis
5 (.24%)
Hyperglycaemia
5 (.24%)
Jaundice
5 (.24%)
Loss Of Consciousness
5 (.24%)
Metastases To Bone
5 (.24%)

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

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

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

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

Breast Cancer
656
Breast Cancer Metastatic
69
Breast Cancer Female
48
Drug Use For Unknown Indication
13
Neoplasm Malignant
7
Product Used For Unknown Indication
6
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Hormone Suppression Therapy
6
Hormone Therapy
6
Ill-defined Disorder
5
Adjuvant Therapy
5
Metastases To Bone
4
Breast Cancer Stage Iii
4
Breast Cancer Recurrent
3
Breast Neoplasm
3
Chemotherapy
3
Ovarian Disorder
3
Antioestrogen Therapy
3
Hormone Level Abnormal
2
Prophylaxis
2
Prophylactic Chemotherapy
2
Ovarian Failure
2
Aromatase Inhibition Therapy
1
Endometriosis
1
Hypertension
1
Lymphangiosis Carcinomatosa
1
Neoplasm Prophylaxis
1
Oophorectomy
1
Blood Oestrogen Decreased
1
Therapeutic Procedure
1

Drug Labels

LabelLabelerEffective
ExemestaneRoxane Laboratories, Inc30-MAR-11
AromasinPharmacia and Upjohn Company22-JAN-13
ExemestaneGreenstone LLC24-JAN-13

Exemestane Case Reports

What Exemestane 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 Exemestane. 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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