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ANASTROZOLE

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Anastrozole Adverse Events Reported to the FDA Over Time

How are Anastrozole adverse event reports trending over time?

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

Most Common Anastrozole Adverse Events Reported to the FDA

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

Arthralgia
72 (3.3%)
Pain
40 (1.83%)
Headache
33 (1.51%)
Dyspnoea
31 (1.42%)
Fatigue
30 (1.37%)
Pain In Extremity
27 (1.24%)
Depression
26 (1.19%)
Hot Flush
25 (1.14%)
Nausea
24 (1.1%)
Diarrhoea
23 (1.05%)
Product Substitution Issue
23 (1.05%)
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Vomiting
22 (1.01%)
Dizziness
21 (.96%)
Anxiety
19 (.87%)
Alopecia
18 (.82%)
Hyponatraemia
18 (.82%)
Suicidal Ideation
18 (.82%)
Breast Cancer
17 (.78%)
Pulmonary Embolism
17 (.78%)
Adverse Drug Reaction
16 (.73%)
Asthenia
16 (.73%)
Cough
16 (.73%)
Myalgia
16 (.73%)
Insomnia
14 (.64%)
Joint Swelling
14 (.64%)
Bone Pain
13 (.59%)
Condition Aggravated
13 (.59%)
Cutaneous Vasculitis
13 (.59%)
Drug Interaction
13 (.59%)
Hip Fracture
13 (.59%)
Cardiac Failure Congestive
12 (.55%)
Feeling Abnormal
12 (.55%)
Myocardial Ischaemia
12 (.55%)
Osteopenia
12 (.55%)
Pleural Effusion
12 (.55%)
Pruritus
12 (.55%)
Sudden Death
12 (.55%)
Hepatic Function Abnormal
11 (.5%)
Paraesthesia
11 (.5%)
Weight Increased
11 (.5%)
Joint Stiffness
10 (.46%)
Metastases To Bone
10 (.46%)
Myocardial Infarction
10 (.46%)
Oedema Peripheral
10 (.46%)
Osteonecrosis
10 (.46%)
Weight Decreased
10 (.46%)
Anaemia
9 (.41%)
Back Pain
9 (.41%)
Chest Pain
9 (.41%)
Drug Ineffective
9 (.41%)
Drug Intolerance
9 (.41%)
Hypoaesthesia
9 (.41%)
Memory Impairment
9 (.41%)
Metastases To Liver
9 (.41%)
Palpitations
9 (.41%)
Abdominal Pain Upper
8 (.37%)
Blood Pressure Increased
8 (.37%)
Drug Dose Omission
8 (.37%)
Drug Hypersensitivity
8 (.37%)
Gait Disturbance
8 (.37%)
Gastrooesophageal Reflux Disease
8 (.37%)
Malaise
8 (.37%)
Phlebitis
8 (.37%)
Blood Pressure Decreased
7 (.32%)
Bundle Branch Block Left
7 (.32%)
Chills
7 (.32%)
Decreased Appetite
7 (.32%)
Dehydration
7 (.32%)
Disturbance In Attention
7 (.32%)
Hallucination, Visual
7 (.32%)
Hyperhidrosis
7 (.32%)
Mood Swings
7 (.32%)
Musculoskeletal Stiffness
7 (.32%)
Pyrexia
7 (.32%)
Skin Lesion
7 (.32%)
Syncope
7 (.32%)
Transient Acantholytic Dermatosis
7 (.32%)
Adverse Event
6 (.27%)
Blood Cholesterol Increased
6 (.27%)
Blood Glucose Increased
6 (.27%)
Breast Cancer Metastatic
6 (.27%)
Burning Sensation
6 (.27%)
Cholestasis
6 (.27%)
Constipation
6 (.27%)
Drug Eruption
6 (.27%)
Hepatic Encephalopathy
6 (.27%)
Hyperkalaemia
6 (.27%)
Hypokalaemia
6 (.27%)
Loss Of Libido
6 (.27%)
Malignant Neoplasm Progression
6 (.27%)
Mobility Decreased
6 (.27%)
Musculoskeletal Pain
6 (.27%)
Pancytopenia
6 (.27%)
Platelet Count Decreased
6 (.27%)
Sleep Disorder
6 (.27%)
Tremor
6 (.27%)
Abdominal Pain
5 (.23%)
Alanine Aminotransferase Increased
5 (.23%)
Anger
5 (.23%)
Antinuclear Antibody Positive
5 (.23%)
Aplastic Anaemia
5 (.23%)

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

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

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

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

Breast Cancer
527
Breast Cancer Metastatic
38
Product Used For Unknown Indication
33
Drug Use For Unknown Indication
31
Hormone Therapy
16
Breast Cancer Female
15
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Neoplasm Malignant
14
Chemotherapy
12
Metastases To Bone
7
Ill-defined Disorder
6
Blood Oestrogen Increased
6
Benign Prostatic Hyperplasia
5
Breast Neoplasm
5
Prophylaxis
5
Adjuvant Therapy
5
Breast Cancer Recurrent
5
Oestrogen Receptor Assay Positive
4
Endocrine Disorder
4
Hypogonadism
4
Antioestrogen Therapy
4
Breast Cancer Stage I
4
Breast Cyst
3
Progesterone Receptor Assay Positiv...
2
Pain
2
Breast Cancer In Situ
2
Hormone Level Abnormal
2
Breast Cancer Stage Iv
2
Blood Testosterone Decreased
2
Neoplasm
1
Testotoxicosis
1
Mastectomy
1
Metastases To Central Nervous Syste...
1
Adenocarcinoma
1
Rash
1
Antiandrogen Therapy
1
Hormone Replacement Therapy
1
Malignant Nipple Neoplasm
1
Brain Tumour Operation
1
Cancer Hormonal Therapy
1
Breast Lump Removal
1
Colorectal Cancer Metastatic
1

Drug Labels

LabelLabelerEffective
AnastrozoleUDL Laboratories, Inc.11-FEB-10
AnastrozoleMylan Pharmaceuticals Inc.11-FEB-10
AnastrozoleBreckenridge Pharmaceutical, Inc.28-JUN-10
AnastrozoleCypress Pharmaceutical, Inc. 28-JUN-10
AnastrozoleThree Rivers Pharmaceuticals, LLC28-JUN-10
AnastrozolePD-Rx Pharmaceuticals, Inc.28-JUN-10
AnastrozoleKaralex Pharma, LLC29-JUN-10
AnastrozoleKAISER FOUNDATION HOSPITALS13-JUL-10
AnastrozolePhysicians Total Care, Inc.22-JUL-10
AnastrozoleAmerican Health Packaging01-OCT-10
AnastrozolePack Pharmaceuticals, LLC09-NOV-10
AnastrozoleMajor Pharmaceuticals16-DEC-10
AnastrozoleRebel Distributors Corp04-JAN-11
AnastrozoleSynthon Pharmaceuticals, Inc.06-JAN-11
AnastrozoleKremers Urban Pharmaceuticals Inc.11-JAN-11
AnastrozoleAscend Laboratories, LLC21-MAR-11
AnastrozoleAscend Laboratories, LLC22-MAR-11
ArimidexAstraZeneca Pharmaceuticals LP27-APR-11
AnastrozoleDr. Reddy's Laboratories Limited17-MAY-11
AnastrozoleRoxane Laboratories, Inc.18-MAY-11
AnastrozoleApotex Corp.30-JUN-11
AnastrozoleGolden State Medical Supply, Inc.01-JUL-11
AnastrozoleSun Pharmaceutical Industries Limited 18-JUL-11
AnastrozoleBoscogen, Inc.29-AUG-11
AnastrozoleAPP Pharmaceuticals, LLC03-SEP-11
AnastrozoleSandoz Inc28-OCT-11
AnastrozoleZydus Pharmaceuticals (USA) Inc.18-NOV-11
AnastrozoleCadila Healthcare Limited19-NOV-11
ArimidexPhysicians Total Care, Inc.01-FEB-12
AnastrozoleRebel Distributors Corp29-FEB-12
AnastrozoleMajor Pharmaceuticals21-AUG-12
AnastrozoleTeva Pharmaceuticals USA Inc06-SEP-12
AnastrozoleAccord Healthcare Inc12-SEP-12

Anastrozole Case Reports

What Anastrozole 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 Anastrozole. 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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