Xtandi Side Effects

Generic Name: enzalutamide

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to enzalutamide: oral capsule liquid filled

Along with its needed effects, enzalutamide (the active ingredient contained in Xtandi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking enzalutamide:

• Back pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• blurred vision
• chest pain
• cough with mucus
• difficulty with breathing
• dizziness
• fever or chills
• loss of bladder or bowel control
• nervousness
• painful or difficult urination
• pounding in the ears
• slow or fast heartbeat
• sore throat
• tingling of the hands or feet
• unable to move the legs
• unusual weight gain or loss

• Anxiety
• confusion or excitement
• depression
• fainting
• falling
• lightheadedness
• loss of memory
• memory or attention span problems
• nightmares or vivid dreams
• rapid, shallow breathing

• Seizures

Some side effects of enzalutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• bone pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• dry throat
• ear congestion
• feeling of constant movement of self or surroundings
• feeling of warmth
• hoarseness
• joint pain
• lack or loss of strength
• loss of voice
• muscle pain, stiffness, or weakness
• pain or tenderness around the eyes and cheekbones
• redness of the face, neck, arms, and upper chest
• sensation of spinning
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble sleeping
• trouble with swallowing
• unusual tiredness or weakness

• Bloody nose
• dry skin
• frequent urination
• itching skin
• pale-colored urine

For Healthcare Professionals

Applies to enzalutamide: oral capsule

Nervous system

Very common (10% or more): Headache (up to 12.1%), dizziness/vertigo (up to 11.3%)
Common (1% to 10%): Spinal cord compression and cauda equina syndrome, paresthesia, mental impairment disorders, hypoesthesia, dysgeusia, restless legs syndrome
Uncommon (0.1% to 1%): Seizures
Postmarketing reports: Posterior reversible encephalopathy syndrome^[Ref]

It is unknown how the drug may lower the seizure threshold; however, it may be related to the drug's ability to inhibit the activity of the GABA-gated chloride channel. The risk of seizure may be related to dose.

Mental impairment disorders included amnesia, memory impairment, cognitive disorder, and disturbance in attention.^[Ref]

Cardiovascular

Very common (10% or more): Hot flush (up to 20.3%), peripheral edema (up to 15.4%), hypertension (up to 14.2%)^[Ref]

Dermatologic

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

Endocrine

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

Gastrointestinal

Very common (10% or more): Constipation (up to 23.2%), diarrhea (up to 21.8%)^[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 (up to 18.9%), decreased weight (up to 12.4%)^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 28.6%), arthralgia (up to 21.4%), musculoskeletal pain (up to 15%)
Common (1% to 10%): Muscular weakness, musculoskeletal stiffness^[Ref]

Other

Fall-related injuries included non-pathologic fractures, joint injuries, and hematomas.^[Ref]

Very common (10% or more): Asthenia/fatigue (up to 50.6%), falls (up to 12.7%)
Common (1% to 10%): Fall-related injuries^[Ref]

Psychiatric

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

Respiratory

Upper respiratory tract infection included nasopharyngitis, sinusitis, rhinitis, pharyngitis, and laryngitis. Lower respiratory tract and lung infection included pneumonia and bronchitis.^[Ref]

Very common (10% or more): Upper respiratory tract infection (up to 16.4%), dyspnea (up to 11%)
Common (1% to 10%): Lower respiratory tract and lung infection, epistaxis^[Ref]

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.

Medical Disclaimer