Note: This document contains side effect information about enzalutamide. Some dosage forms listed on this page may not apply to the brand name Xtandi.

Summary

Common side effects of Xtandi include: upper respiratory tract infection, headache, hot flash, laryngitis, nasopharyngitis, pharyngitis, rhinitis, and sinusitis. Other side effects include: lower respiratory tract infection, pneumonia, pulmonary infection, altered mental status, amnesia, bronchitis, cognitive dysfunction, falling, hypertension, hypoesthesia, and memory impairment. Continue reading for a comprehensive list of adverse effects.

Applies to enzalutamide: oral capsules or tablets.

Side effects include:

Adverse effects reported in ≥10% of patients and at an incidence that is ≥2% higher than that reported with placebo: Asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, hypertension. Laboratory abnormalities reported in ≥5% of patients and at an incidence that is >2% higher than that reported with placebo: Leukopenia, neutropenia, hyperglycemia, hypermagnesemia, hyponatremia, hypercalcemia.

Adverse effects reported in ≥10% of patients and at an incidence that is ≥ 2% higher than that reported with bicalutamide: Asthenia/fatigue, musculoskeletal pain, hot flush, hypertension, diarrhea, upper respiratory tract infection, decreased weight.

For Healthcare Professionals

Applies to enzalutamide: oral capsule, oral tablet.

Nervous system

Very common (10% or more): Headache (12%), dizziness/vertigo (11%)

Common (1% to 10%): Spinal cord compression and cauda equina syndrome, paresthesia, hypoesthesia, dysgeusia, restless legs syndrome

Uncommon (0.1% to 1%): Seizures

Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES) (e.g., seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension)^[Ref]

Cardiovascular

Very common (10% or more): Hot flush (20%), peripheral edema (15%), hypertension (14%)^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, dry skin

Postmarketing reports: Rash^[Ref]

Endocrine

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

Gastrointestinal

Very common (10% or more): Constipation (23%), diarrhea (22%)

Common (1% to 10%): Hematuria, pollakiuria

Postmarketing reports: Vomiting^[Ref]

Genitourinary

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

Hematologic

Very common (10% or more): Neutropenia (15%)

Common (1% to 10%): Thrombocytopenia

Frequency not reported: Leukopenia^[Ref]

Hepatic

Very common (10% or more): ALT elevations (10%)

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

Metabolic

Very common (10% or more): Decreased appetite (19%), decreased weight (12%)^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (29%), arthralgia (21%), musculoskeletal pain (15%)

Common (1% to 10%): Muscular weakness, musculoskeletal stiffness^[Ref]

Other

Very common (10% or more): Asthenia/fatigue (51%), falls (13%)

Common (1% to 10%): Fall-related injuries^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, hallucinations, mental impairment disorders^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (16%), dyspnea (11%)

Common (1% to 10%): Lower respiratory tract and lung infection, epistaxis^[Ref]

Hypersensitivity

Postmarketing reports: Face edema, tongue edema, lip edema, pharynx edema^[Ref]

Ocular

Postmarketing reports: Blindness and other visual disturbances due to posterior reversible encephalopathy syndrome (PRES)^[Ref]