Erleada Side Effects

Generic name: apalutamide

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Note: This document provides detailed information about Erleada Side Effects associated with apalutamide. Some dosage forms listed on this page may not apply specifically to the brand name Erleada.

Applies to apalutamide: oral tablet.

Serious side effects of Erleada

Along with its needed effects, apalutamide (the active ingredient contained in Erleada) 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 apalutamide:

Other side effects of Erleada

Some side effects of apalutamide 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:

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Women and children should not use this medicine. Apalutamide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use an effective method 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.

Do not donate sperm during treatment with this medicine and for 3 months after your last dose.

Do not stop using this medicine, even for a short time, without first asking your doctor.

This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Serious skin reactions (eg, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis), which can be life-threatening can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

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 or vitamin supplements.

For healthcare professionals

Applies to apalutamide: oral tablet.

General adverse events

The most frequently reported side effects are fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, appetite decreased, fracture, and peripheral edema.^[Ref]

Hematologic

• Very common (10% or more): Anemia (70%), leukopenia (47%), lymphopenia (41%)^[Ref]

Metabolic

• Very common (10% or more): Hypercholesterolemia (76%), hyperglycemia (70%), hypertriglyceridemia (67%), hyperkalemia (32%), appetite disorder (appetite decreased, early satiety, hypophagia) (12%)^[Ref]

Genitourinary

• Common (1% to 10%): Hematuria^[Ref]

Other

• Very common (10% or more): Fatigue/asthenia (39%), fall (16%), edema (peripheral edema, generalized edema, edema, edema genital, penile edema, peripheral swelling, scrotal edema, lymphedema, swelling, localized edema) (11%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (25%), hot flush (14%)
• Common (1% to 10%): Ischemic heart disease, heart failure
• Frequency not reported: Myocardial infarction, cardiopulmonary arrest^[Ref]

Dermatologic

• Very common (10% or more): Rash (maculopapular rash, generalized rash, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, and rash vesicular) (24%)
• Common (1% to 10%): Pruritus^[Ref]

Endocrine

• Very common (10% or more): Thyroid stimulating hormone elevated
• Common (1% to 10%): Hypothyroidism^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (20%), nausea (18%)^[Ref]

Nervous system

• Uncommon (0.1% to 1%): Seizure
• Frequency not reported: Cerebral hemorrhage^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (16%), fracture (e.g., rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture) (12%)^[Ref]

Immunologic

• Frequency not reported: Infection^[Ref]

See also:

Frequently asked questions

• What is the mechanism of action for Erleada?
• Erleada vs. Xtandi: What's the difference?
• How long do you have to take Erleada (apalutamide) for?
• How effective is Erleada (apalutamide)?
• What type of prostate cancer is Erleada used to treat?

Further information

Erleada 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.

Medical Disclaimer