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Bicalutamide Adverse Events Reported to the FDA Over Time

How are Bicalutamide adverse event reports trending over time?

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

Most Common Bicalutamide Adverse Events Reported to the FDA

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

Interstitial Lung Disease
29 (3%)
Dyspnoea
23 (2.38%)
Renal Failure Acute
15 (1.55%)
Prostate Cancer
12 (1.24%)
Anaemia
11 (1.14%)
Drug Interaction
11 (1.14%)
Drug Ineffective
10 (1.03%)
Oedema Peripheral
10 (1.03%)
Cardiac Failure
9 (.93%)
Loss Of Consciousness
9 (.93%)
Osteoporosis
9 (.93%)
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Prostatic Specific Antigen Increase...
9 (.93%)
Thrombocytopenia
9 (.93%)
Hypotension
8 (.83%)
International Normalised Ratio Incr...
8 (.83%)
Arthralgia
7 (.72%)
Cardiac Failure Congestive
7 (.72%)
Constipation
7 (.72%)
Hyperglycaemia
7 (.72%)
Joint Swelling
7 (.72%)
Multi-organ Failure
7 (.72%)
Nausea
7 (.72%)
Pyrexia
7 (.72%)
Renal Failure
7 (.72%)
Skin Infection
7 (.72%)
Torsade De Pointes
7 (.72%)
Cardiomegaly
6 (.62%)
Exercise Tolerance Decreased
6 (.62%)
Eye Pain
6 (.62%)
Eye Pruritus
6 (.62%)
Fatigue
6 (.62%)
Haematuria
6 (.62%)
Hypokalaemia
6 (.62%)
Scotoma
6 (.62%)
Weight Increased
6 (.62%)
Aspartate Aminotransferase Increase...
5 (.52%)
Asthenia
5 (.52%)
Dilatation Ventricular
5 (.52%)
Dizziness
5 (.52%)
Electrocardiogram Qt Prolonged
5 (.52%)
Extradural Haematoma
5 (.52%)
Fall
5 (.52%)
Haemoglobin Decreased
5 (.52%)
Hepatotoxicity
5 (.52%)
Liver Function Test Abnormal
5 (.52%)
Lymphoedema
5 (.52%)
Oxygen Saturation Decreased
5 (.52%)
Pain
5 (.52%)
Pelvic Pain
5 (.52%)
Penile Oedema
5 (.52%)
Pruritus
5 (.52%)
Somnolence
5 (.52%)
Speech Disorder
5 (.52%)
Subdural Haematoma
5 (.52%)
Thrombosis
5 (.52%)
Toxic Skin Eruption
5 (.52%)
Vision Blurred
5 (.52%)
Vomiting
5 (.52%)
Acute Myocardial Infarction
4 (.41%)
Anorexia
4 (.41%)
Blood Urine Present
4 (.41%)
C-reactive Protein Increased
4 (.41%)
Chest Pain
4 (.41%)
Decreased Appetite
4 (.41%)
Diabetes Mellitus
4 (.41%)
Diarrhoea
4 (.41%)
Disease Progression
4 (.41%)
Dysphagia
4 (.41%)
Insulin Resistance
4 (.41%)
Jaundice Cholestatic
4 (.41%)
Metastases To Bone
4 (.41%)
Myalgia
4 (.41%)
Neutropenia
4 (.41%)
Pneumonia
4 (.41%)
Pneumonia Bacterial
4 (.41%)
Respiratory Failure
4 (.41%)
Schizophrenia
4 (.41%)
Syncope
4 (.41%)
Tachycardia
4 (.41%)
Ventricular Extrasystoles
4 (.41%)
Ventricular Tachycardia
4 (.41%)
Visual Impairment
4 (.41%)
White Blood Cell Count Increased
4 (.41%)
Acute Psychosis
3 (.31%)
Alanine Aminotransferase Increased
3 (.31%)
Anuria
3 (.31%)
Blood Potassium Decreased
3 (.31%)
Condition Aggravated
3 (.31%)
Cough
3 (.31%)
Death
3 (.31%)
Dementia
3 (.31%)
Dermatitis Acneiform
3 (.31%)
Dermatitis Bullous
3 (.31%)
Disseminated Intravascular Coagulat...
3 (.31%)
Drug Hypersensitivity
3 (.31%)
Gastric Ulcer
3 (.31%)
Gastrointestinal Haemorrhage
3 (.31%)
General Physical Health Deteriorati...
3 (.31%)
Gynaecomastia
3 (.31%)
Hepatic Function Abnormal
3 (.31%)
Hepatitis Cholestatic
3 (.31%)

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

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

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

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

Prostate Cancer
323
Prostate Cancer Stage Iv
306
Prostate Cancer Stage Ii
153
Drug Use For Unknown Indication
108
Prostate Cancer Stage Iii
99
Product Used For Unknown Indication
67
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Antiandrogen Therapy
20
Prostate Cancer Stage I
14
Prostate Cancer Metastatic
14
Prostatic Specific Antigen Increase...
6
Benign Prostatic Hyperplasia
5
Neoplasm Malignant
4
Metastases To Bone
4
Prostate Cancer Recurrent
4
Prophylaxis
3
Prostatic Operation
3
Neoplasm Prostate
3
Ill-defined Disorder
2
Bone Cancer Metastatic
2
Prostatic Specific Antigen
2
Tumour Flare
2
Chemotherapy
2
Hormone Suppression Therapy
1
Obesity
1
Adenocarcinoma
1
Feeling Hot
1
Prostatic Disorder
1
Pain
1
Testotoxicosis
1
Hormone Therapy
1
Adjuvant Therapy
1
Anticoagulant Therapy
1
Asthma
1

Drug Labels

LabelLabelerEffective
BicalutamideMylan Pharmaceuticals Inc01-JUN-09
BicalutamidePhysicians Total Care, Inc.06-JUL-09
BicalutamideDava Pharmaceuticals, Inc.17-JUL-09
CasodexAstraZeneca Pharmaceuticals LP30-NOV-09
BicalutamideUDL Laboratories, Inc.09-DEC-09
BicalutamideMajor Pharmaceuticals11-MAY-10
BicalutamideSynthon Pharmaceuticals, Inc.14-OCT-10
BicalutamideBreckenridge Pharmaceutical, Inc.16-NOV-10
BicalutamideNorthstar Rx LLC24-JAN-11
BicalutamideAmerican Health Packaging24-MAY-11
BicalutamideZydus Pharmaceuticals (USA) Inc.14-NOV-11
BicalutamideCadila Healthcare Limited16-NOV-11
BicalutamideGolden State Medical Supply, Inc.09-JAN-12
CasodexPhysicians Total Care, Inc.27-JAN-12
BicalutamideTeva Pharmaceuticals USA Inc07-AUG-12
BicalutamideAccord Healthcare Inc10-AUG-12
BicalutamideSandoz Inc15-AUG-12
BicalutamideSUN PHARMA GLOBAL INC.21-AUG-12
BicalutamideApotex Corp.22-AUG-12
BicalutamideAmerican Health Packaging29-NOV-12

Bicalutamide Case Reports

What Bicalutamide 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 Bicalutamide. 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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