Applies to apalutamide: oral tablets.

Side effects include:

Adverse effects reported in ≥10% of patients receiving apalutamide include fatigue, arthralgia, rash, decreased appetite, falls, decreased weight, hypertension, hot flush, diarrhea, and fracture.

For Healthcare Professionals

Applies to apalutamide: oral tablet.

General

The most frequently reported side effects are fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, appetite decreased, fracture, and peripheral edema.^[Ref]

Hematologic

Very common (10% or more): Anemia (70%), leukopenia (47%), lymphopenia (41%)^[Ref]

Metabolic

Very common (10% or more): Hypercholesterolemia (76%), hyperglycemia (70%), hypertriglyceridemia (67%), hyperkalemia (32%), appetite disorder (appetite decreased, early satiety, hypophagia) (12%)^[Ref]

Genitourinary

Common (1% to 10%): Hematuria^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (39%), fall (16%), edema (peripheral edema, generalized edema, edema, edema genital, penile edema, peripheral swelling, scrotal edema, lymphedema, swelling, localized edema) (11%)^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (25%), hot flush (14%)

Common (1% to 10%): Ischemic heart disease, heart failure

Frequency not reported: Myocardial infarction, cardiopulmonary arrest^[Ref]

Dermatologic

Very common (10% or more): Rash (maculopapular rash, generalized rash, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, and rash vesicular) (24%)

Common (1% to 10%): Pruritus^[Ref]

Endocrine

Very common (10% or more): Thyroid stimulating hormone elevated

Common (1% to 10%): Hypothyroidism^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (20%), nausea (18%)^[Ref]

Nervous system

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Cerebral hemorrhage^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (16%), fracture (e.g., rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture) (12%)^[Ref]

Immunologic

Frequency not reported: Infection^[Ref]