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.

Some side effects of Xtandi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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:

More common
  • Back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in urine
  • blurred vision
  • chest pain
  • cough
  • cough with mucus
  • difficulty breathing
  • dizziness
  • fever or chills
  • headache
  • loss of bladder control
  • loss of bowel control
  • nervousness
  • no sensation in the legs
  • painful or difficult urination
  • pounding in the ears
  • rapid weight gain
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • unable to move legs
  • unusual weight gain or loss
  • wheezing
Less common
  • Confusion or excitement
  • fainting
  • falling
  • lightheadedness
  • loss of memory
  • mental depression or anxiety
  • nightmares or unusually vivid dreams
  • problems with memory or attention span
  • rapid, shallow breathing
  • trouble performing routine tasks
Rare
  • 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:

More common
  • Body aches or pain
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • difficulty in 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
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms and occasionally, upper chest
  • sensation of spinning
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • trouble sleeping
  • unusual tiredness or weakness
  • voice changes
Less common
  • Bloody nose
  • dry skin
  • frequent urination
  • itching skin
  • pale-colored urine

For Healthcare Professionals

Applies to enzalutamide: oral capsule

Cardiovascular

Very common (10% or more): Hot flush (20.3%), peripheral edema (15.4%)
Common (1% to 10%): Hypertension (6.4%)

Dermatologic

Common (1% to 10%): Pruritus (3.8%), dry skin (3.5%)

Gastrointestinal

Very common (10% or more): Diarrhea (21.8%)

Genitourinary

Common (1% to 10%): Hematuria (6.9%), pollakiuria (4.8%)

Hematologic

Very common (10% or more): Neutropenia (15%)
Uncommon (0.1% to 1%): Thrombocytopenia (0.5%)
Frequency not reported: Small increases in mean QTc interval

Hepatic

Very common (10% or more): Elevations in ALT (10%)
Common (1% to 10%): Elevations in bilirubin (3%)

Musculoskeletal

Very common (10% or more): Back pain (26.4%), arthralgia (20.5%), musculoskeletal pain (15%)
Common (1% to 10%): Muscular weakness (9.8%), musculoskeletal stiffness (2.6%)

Nervous system

Very common (10% or more): Headache (12.1%)
Common (1% to 10%): Dizziness, includes vertigo (9.5%), spinal cord compression and cauda equina syndrome (7.4%), paresthesia (6.6%), mental impairment, includes amnesia, memory impairment, cognitive disorder, and disturbance in attention (4.3%), hypoesthesia (4%)

Other

Very common (10% or more): Asthenic conditions, including asthenia and fatigue (50.6%)
Common (1% to 10%): Falls (4.6%), non-pathologic fractures (4%)

Psychiatric

Common (1% to 10%): Insomnia (8.8%), anxiety (6.5%), hallucinations (1.6%)

Respiratory

Very common (10% or more): Upper respiratory tract infection, includes nasopharyngitis, sinusitis, rhinitis, pharyngitis, and laryngitis (10.9%)
Common (1% to 10%): Lower respiratory tract and lung infection, includes pneumonia, and bronchitis (8.5%), epistaxis (3.3%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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