Update on NUPLAZID — FDA finds no new or unexpected safety risks

WASHINGTON (September 20, 2018) — On September 20, 2018, the U.S. Food and Drug Administration (FDA) issued a review on the drug NUPLAZID (pimavanserin), a medication used to treat patients with hallucinations and delusions associated with Parkinson’s Disease psychosis.

According to the FDA website:

“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings with NUPLAZID, or findings that are inconsistent with the established safety profile currently described in the drug label. After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis...

Patients taking NUPLAZID for Parkinson’s disease psychosis should continue to use it as prescribed by their health care provider. FDA continues to monitor reports of adverse events associated with NUPLAZID.”

NUPLAZID was approved by the FDA in 2016 and is manufactured by Acadia Pharmaceuticals. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson’s Disease psychosis.

For more information on this topic, please call our toll-free Helpline at 1-800-4PD-INFO (473-4636). 

For background about this issue, please read our previous statement related to Nuplazid.

For more information about Psychosis and Parkinson’s Disease:


About the Parkinson’s Foundation
The Parkinson’s Foundation makes life better for people with Parkinson’s disease by improving care and advancing research toward a cure. In everything we do, we build on the energy, experience and passion of our global Parkinson’s community. Since 1957, the Parkinson’s Foundation has invested more than $400 million in Parkinson’s research and clinical care. Connect with us on Parkinson.orgFacebookTwitterInstagram or call (800) 4PD-INFO (473-4636).

About Parkinson’s Disease
Affecting an estimated one million Americans and 10 million worldwide, Parkinson’s disease is the second-most common neurodegenerative disease after Alzheimer’s and is the 14th-leading cause of death in the U.S. It is associated with a progressive loss of motor control (e.g., shaking or tremor at rest and lack of facial expression), as well as non-motor symptoms (e.g., depression and anxiety). There is no cure for Parkinson’s and 60,000 new cases are diagnosed each year in the U.S. alone.

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