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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]

Frequently asked questions

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.

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