Weight gain has been reported in a 6-week clinical study with Ingrezza, but it is not a common side effect. In this study with 151 patients taking either the 40 mg/day or 80 mg/day dose, 3 patients had weight gain (2%) compared to zero patients (0%) in the placebo (inactive treatment) group.

• Out of 72 patients who received the 40 mg/day dose, one patient (1.4%) had a weight increase.
• Out of 79 patients who received the 80 mg/day dose, two patients (2.5%) had a weight gain.
• Your doctor may prescribe Ingrezza with other medicines, such as antipsychotic medications, that can lead to weight gain. Speak with your doctor if you are concerned about weight gain with your treatment regimen.

Ingrezza (valbenazine) is approved by the FDA to treat adults with tardive dyskinesia, which is a disorder that causes movements that cannot be controlled in the face, tongue, or other body parts. It works by blocking certain chemicals in your body that may be involved with involuntary muscle movement.

In general, Ingrezza is well-tolerated. In studies, a total of 3% of Ingrezza-treated patients and 2% of placebo-treated patients stopped treatment due to side effects.

The most common side effect (≥5% and twice the rate of placebo) reported with Ingrezza is somnolence (sleepiness) in 10.9% of patients, compared to 4.2% of patients taking a placebo. Other possible side effects are abnormal heart rhythms, Parkinson-like symptoms (movement disorders), dry mouth, headache, constipation, restlessness, and blurred vision.

Do not drive, operate machinery, or do any hazardous activity that requires mental alertness until you know how Ingrezza affects you.

Ingrezza is taken as an oral capsule once a day, with or without food. It is available as a 40 mg, 60 mg and 80 mg capsules. If you have liver disease, you may need a lower dose. Your doctor will determine your specific dose. Do not stop taking your medicine without speaking with your healthcare provider first.

Neurocrine Biosciences is the manufacturer and it is available through a special pharmacy network in the U.S.

This is not all the information you need to know about Ingrezza (valbenazine) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Ingrezza information here, and discuss this information and any questions you have with your doctor or other health care provider.