APALUTAMIDE

N/A

Manufactured by Janssen Products, LP

16,304 FDA adverse event reports analyzed

Last updated: 2026-04-14

About APALUTAMIDE

APALUTAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Products, LP. The most commonly reported adverse reactions for APALUTAMIDE include RASH, DEATH, FATIGUE, HOT FLUSH, PRODUCT DOSE OMISSION ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for APALUTAMIDE.

Top Adverse Reactions

RASH1,185 reports
DEATH1,145 reports
FATIGUE1,093 reports
HOT FLUSH821 reports
PRODUCT DOSE OMISSION ISSUE430 reports
ASTHENIA405 reports
DIARRHOEA384 reports
DIZZINESS346 reports
OFF LABEL USE343 reports
ARTHRALGIA329 reports
FALL312 reports
DECREASED APPETITE298 reports
PROSTATIC SPECIFIC ANTIGEN INCREASED293 reports
INCORRECT DOSE ADMINISTERED278 reports
PRURITUS252 reports
DRUG INEFFECTIVE240 reports
NAUSEA235 reports
WEIGHT DECREASED231 reports
HOSPITALISATION225 reports
HYPERTENSION214 reports
DYSPNOEA203 reports
DRUG INTERACTION194 reports
INSOMNIA177 reports
PAIN177 reports
MALAISE163 reports
HEADACHE154 reports
THERAPY CESSATION154 reports
BACK PAIN151 reports
CONSTIPATION143 reports
PAIN IN EXTREMITY143 reports
PYREXIA136 reports
PNEUMONIA135 reports
DISEASE PROGRESSION132 reports
URINARY TRACT INFECTION128 reports
HYPERHIDROSIS126 reports
THERAPY INTERRUPTED126 reports
ANAEMIA122 reports
BLOOD PRESSURE INCREASED120 reports
WEIGHT INCREASED117 reports
ERYTHEMA107 reports
PERIPHERAL SWELLING105 reports
NEUTROPENIA104 reports
ADVERSE DRUG REACTION102 reports
ADVERSE EVENT96 reports
OEDEMA PERIPHERAL96 reports
PROSTATE CANCER95 reports
MYOCARDIAL INFARCTION94 reports
INTERSTITIAL LUNG DISEASE93 reports
CEREBROVASCULAR ACCIDENT91 reports
MUSCULAR WEAKNESS91 reports
MYALGIA91 reports
BLOOD GLUCOSE INCREASED89 reports
COVID 1989 reports
SEIZURE89 reports
GAIT DISTURBANCE88 reports
BALANCE DISORDER86 reports
RASH PRURITIC86 reports
HYPOTHYROIDISM84 reports
DRY SKIN83 reports
ALOPECIA82 reports
FEELING ABNORMAL82 reports
ATRIAL FIBRILLATION77 reports
DYSPHAGIA77 reports
VOMITING75 reports
SOMNOLENCE74 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS73 reports
PROSTATE CANCER METASTATIC73 reports
HYPOAESTHESIA72 reports
POLLAKIURIA71 reports
TREATMENT NONCOMPLIANCE70 reports
CHEST PAIN67 reports
METASTASES TO BONE66 reports
ABDOMINAL DISCOMFORT65 reports
INCORRECT DOSAGE ADMINISTERED65 reports
MEMORY IMPAIRMENT65 reports
CARDIAC FAILURE64 reports
HYPERSENSITIVITY64 reports
NEUROPATHY PERIPHERAL64 reports
BONE PAIN63 reports
DYSGEUSIA63 reports
SKIN EXFOLIATION60 reports
COUGH59 reports
DEPRESSION59 reports
DYSURIA59 reports
SYNCOPE59 reports
HYPOTENSION58 reports
TASTE DISORDER58 reports
CONFUSIONAL STATE57 reports
RASH MACULO PAPULAR57 reports
MUSCLE SPASMS56 reports
CARDIAC DISORDER55 reports
CHILLS55 reports
URTICARIA55 reports
ERECTILE DYSFUNCTION54 reports
GENERAL PHYSICAL HEALTH DETERIORATION53 reports
DEHYDRATION52 reports
NIGHT SWEATS52 reports
RASH ERYTHEMATOUS52 reports
URINARY RETENTION52 reports
ABDOMINAL PAIN UPPER51 reports

Report Outcomes

Out of 10,955 classified reports for APALUTAMIDE:

Serious 61.8%Non-Serious 38.2%

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

Male9,322 (99.6%)
Female39 (0.4%)

Reports by Age

Age 73258 reports
Age 76258 reports
Age 78249 reports
Age 75235 reports
Age 80235 reports
Age 79226 reports
Age 74224 reports
Age 77217 reports
Age 71215 reports
Age 81210 reports
Age 72206 reports
Age 70205 reports
Age 83200 reports
Age 82194 reports
Age 69178 reports
Age 84175 reports
Age 85163 reports
Age 67151 reports
Age 68143 reports
Age 86136 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 APALUTAMIDE?

This profile reflects 16,304 FDA FAERS reports that mention APALUTAMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for APALUTAMIDE?

Frequently reported terms in FAERS include RASH, DEATH, FATIGUE, HOT FLUSH, PRODUCT DOSE OMISSION ISSUE, ASTHENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures APALUTAMIDE?

Labeling and FAERS entries often list Janssen Products, LP in connection with APALUTAMIDE. 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.