Possible Side
Effects of Taking ERLEADA

ERLEADA May Cause Serious Side Effects, Including:

Heart disease, stroke, or
mini-stroke

Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA (apalutamide) and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA. Call your healthcare provider or get medical help right away if you get:

chest pain or discomfort at rest or with activity
shortness of breath
numbness or weakness of the face, arm, or leg, especially on one side of the body
trouble talking or understanding
trouble seeing in one or both eyes
dizziness, loss of balance or coordination, or trouble walking

Fractures and falls

ERLEADA treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in men during treatment with ERLEADA. Your healthcare provider will monitor your risk for falls and fractures during treatment with ERLEADA.

Seizure

Treatment with ERLEADA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA if you have a seizure during treatment.

Severe skin reactions

Treatment with ERLEADA may cause severe skin reactions that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any of these signs or symptoms of a severe skin reaction:

severe rash or rash that continues to get worse
fever or flu-like symptoms
swollen lymph nodes
blisters or sores in the mouth, throat, nose, eyes, or genital area
blistering or peeling of the skin

Lung problems

Treatment with ERLEADA may cause inflammation of the lungs that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any new or worsening symptoms of lung problems, including:

shortness of breath
cough
fever

The Most Common Side Effects of ERLEADA Include:

feeling
very tired

joint pain

rash

decreased
appetite

fall

weight loss

high blood
pressure

hot flash

diarrhea

fracture

Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with ERLEADA (apalutamide) if you have certain side effects.

INSIGHT

98% of patients did not stop taking ERLEADA because of rash

Rashes were mild to moderate and manageable with the help of a healthcare provider. ERLEADA may cause severe skin reactions including severe rash.

ERLEADA skin care and rash management patient brochure cover

Get Simple Tips for Managing Rash

Download our rash management guide for helpful information.

See the Rash Management brochure

ERLEADA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA and for 3 months after the last dose of ERLEADA.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ERLEADA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.