Xtandi Side Effects
Generic name: enzalutamide
Medically reviewed by Drugs.com. Last updated on May 5, 2025.
Note: This document provides detailed information about Xtandi.
Applies to enzalutamide: oral capsule liquid filled, oral tablet Side Effects associated with enzalutamide. Some dosage forms listed on this page may not apply specifically to the brand name Xtandi.
Applies to enzalutamide: oral capsule liquid filled, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men with female partners must use a condom together with a second effective form of birth control during treatment with this medicine and for 3 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
This medicine may cause dizziness, tiredness, muscle weakness, seizures (very rare), and an increased risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause a nerve problems called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you have seizures, headache, confusion, unusual drowsiness, dullness, tiredness, weakness, feeling of sluggishness, or blurred vision.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a fast heartbeat, fever, joint pain, stiffness, or swelling, rash, redness of the skin, swelling of the eyelids, face, tongue, lips, hands, or feet, tightness in the chest, or trouble with breathing or swallowing.
Enzalutamide may cause heart problems including ischemic heart disease. Check with your doctor right away if you have chest pain or discomfort or pain or discomfort in the arms, jaw, back, or neck.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Xtandi
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 side effects
- back pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- blurred vision
- chest pain
- chills
- cough with mucus
- difficulty with breathing
- dizziness
- fever
- 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
Less common side effects
- anxiety
- confusion or excitement
- depression
- fainting
- falling
- lightheadedness
- loss of memory
- memory or attention span problems
- nightmares or vivid dreams
- rapid, shallow breathing
Rare side effects
- seizures
Incidence not known
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble breathing or swallowing
- unusual drowsiness, tiredness, weakness, or feeling of sluggishness
Other side effects of Xtandi
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 side effects
- body aches or pain
- bone pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- diarrhea
- difficulty having a bowel movement
- difficulty with moving
- dry throat
- ear congestion
- feeling of constant movement of self or surroundings
- feeling of warmth
- lack or loss of strength
- loss of voice
- muscle pain, stiffness, or weakness
- pain or tenderness around the eyes and cheekbones
- sensation of spinning
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble sleeping
Less common side effects
- bloody nose
- dry skin
- frequent urination
- pale-colored urine
For healthcare professionals
Applies to enzalutamide: oral capsule, oral tablet.
Nervous system adverse events
- 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
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
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. (2012) "Product Information. Xtandi (enzalutamide)." Astellas Pharma US, Inc
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Further information
Xtandi side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.