BICALUTAMIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

27,404 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BICALUTAMIDE

BICALUTAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for BICALUTAMIDE include FATIGUE, DEATH, PROSTATIC SPECIFIC ANTIGEN INCREASED, ASTHENIA, HOT FLUSH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BICALUTAMIDE.

Top Adverse Reactions

FATIGUE1,301 reports
DEATH972 reports
PROSTATIC SPECIFIC ANTIGEN INCREASED923 reports
ASTHENIA794 reports
HOT FLUSH776 reports
PROSTATE CANCER742 reports
MALIGNANT NEOPLASM PROGRESSION706 reports
DRUG INEFFECTIVE598 reports
DIZZINESS574 reports
NAUSEA556 reports
DYSPNOEA533 reports
DIARRHOEA515 reports
DECREASED APPETITE501 reports
ANAEMIA485 reports
FALL419 reports
METASTASES TO BONE416 reports
OFF LABEL USE415 reports
PAIN403 reports
PNEUMONIA389 reports
BACK PAIN385 reports
ARTHRALGIA373 reports
CONSTIPATION372 reports
WEIGHT DECREASED369 reports
INTERSTITIAL LUNG DISEASE364 reports
MALAISE363 reports
DISEASE PROGRESSION335 reports
PYREXIA326 reports
CONFUSIONAL STATE305 reports
DRUG INTERACTION286 reports
VOMITING286 reports
PROSTATE CANCER METASTATIC282 reports
HAEMATURIA277 reports
PAIN IN EXTREMITY275 reports
HYPERTENSION272 reports
INSOMNIA268 reports
OSTEONECROSIS OF JAW260 reports
HEADACHE251 reports
HYPOTENSION235 reports
GAIT DISTURBANCE231 reports
CONDITION AGGRAVATED224 reports
URINARY TRACT INFECTION224 reports
CARDIAC FAILURE221 reports
MUSCULAR WEAKNESS218 reports
RASH216 reports
OEDEMA PERIPHERAL207 reports
DEHYDRATION199 reports
HAEMOGLOBIN DECREASED199 reports
CHEST PAIN186 reports
ACUTE KIDNEY INJURY182 reports
HYPERHIDROSIS182 reports
GENERAL PHYSICAL HEALTH DETERIORATION181 reports
RENAL FAILURE181 reports
PLATELET COUNT DECREASED180 reports
URINARY RETENTION179 reports
BONE PAIN176 reports
MYOCARDIAL INFARCTION171 reports
WEIGHT INCREASED170 reports
SYNCOPE169 reports
HEPATIC FUNCTION ABNORMAL167 reports
THROMBOCYTOPENIA166 reports
PERIPHERAL SWELLING164 reports
MYALGIA163 reports
PRURITUS162 reports
ABDOMINAL PAIN157 reports
SOMNOLENCE155 reports
CARDIAC FAILURE CONGESTIVE153 reports
CEREBROVASCULAR ACCIDENT153 reports
LOSS OF CONSCIOUSNESS153 reports
ATRIAL FIBRILLATION150 reports
COUGH150 reports
GYNAECOMASTIA150 reports
DEPRESSION148 reports
MEMORY IMPAIRMENT144 reports
FEELING ABNORMAL140 reports
INJECTION SITE PAIN139 reports
BLOOD GLUCOSE INCREASED138 reports
DYSURIA138 reports
POLLAKIURIA138 reports
NEUTROPENIA137 reports
PULMONARY EMBOLISM135 reports
ANXIETY131 reports
RENAL IMPAIRMENT127 reports
HYPOAESTHESIA126 reports
ABDOMINAL PAIN UPPER121 reports
BLOOD PRESSURE INCREASED121 reports
SEPSIS118 reports
PRODUCT USE IN UNAPPROVED INDICATION117 reports
PLEURAL EFFUSION116 reports
METASTASES TO LYMPH NODES115 reports
BLOOD CREATININE INCREASED114 reports
DYSPHAGIA114 reports
ABDOMINAL DISCOMFORT112 reports
ALANINE AMINOTRANSFERASE INCREASED112 reports
OSTEONECROSIS112 reports
HYPOCALCAEMIA111 reports
RESPIRATORY FAILURE111 reports
ELECTROCARDIOGRAM QT PROLONGED109 reports
RENAL DISORDER107 reports
CHILLS106 reports
DEMENTIA ALZHEIMER^S TYPE106 reports

Report Outcomes

Out of 14,924 classified reports for BICALUTAMIDE:

Serious 82.8%Non-Serious 17.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male13,715 (98.6%)
Female175 (1.3%)
Unknown22 (0.2%)

Reports by Age

Age 78474 reports
Age 75455 reports
Age 80422 reports
Age 74391 reports
Age 79389 reports
Age 77385 reports
Age 76378 reports
Age 83373 reports
Age 73356 reports
Age 70349 reports
Age 72347 reports
Age 71342 reports
Age 82329 reports
Age 69325 reports
Age 81322 reports
Age 68282 reports
Age 85278 reports
Age 84277 reports
Age 67270 reports
Age 86258 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BICALUTAMIDE?

This profile reflects 27,404 FDA FAERS reports that mention BICALUTAMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BICALUTAMIDE?

Frequently reported terms in FAERS include FATIGUE, DEATH, PROSTATIC SPECIFIC ANTIGEN INCREASED, ASTHENIA, HOT FLUSH, PROSTATE CANCER. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BICALUTAMIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with BICALUTAMIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.