It is not known if INGREZZA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
Do not take INGREZZA if you:
INGREZZA may cause serious side effects, including:
- Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA.
- Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, dizziness or fainting, or shortness of breath.
- Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
- Neuroleptic Malignant Syndrome (NMS): NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
- Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.
Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Sleepiness (sedation) is a common side effect with INGREZZA. While taking INGREZZA, do not drive a car or operate dangerous machinery until you know how INGREZZA affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking INGREZZA may increase any sleepiness caused by INGREZZA.
The most common side effect of INGREZZA in people with tardive dyskinesia is sleepiness (somnolence).
The most common side effects of INGREZZA in people with Huntington’s disease are sleepiness (somnolence), allergic itching, rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see INGREZZA full Prescribing Information, including Boxed Warning.