Xtandi Side Effects

Generic Name: enzalutamide

Note: This page contains side effects data for the generic drug enzalutamide. It is possible that some of the dosage forms included below 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

As well as its needed effects, enzalutamide (the active ingredient contained in Xtandi) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking enzalutamide, check with your doctor immediately:

• 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

Minor Side Effects

Some enzalutamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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]

It is possible that some side effects of Xtandi may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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