Xtandi Side Effects
Generic name: enzalutamide
Medically reviewed by Drugs.com. Last updated on May 13, 2022.
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]
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References
1. "Product Information. Xtandi (enzalutamide)." Astellas Pharma US, Inc (2012):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.