SAPHRIS is a type of medicine called an atypical antipsychotic. It is approved for the treatment of schizophrenia in adults.

Important Safety Information

Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (see Boxed Warning). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Serious allergic reaction: Do not take SAPHRIS if you are allergic to any of its ingredients. Seek immediate emergency assistance if you have symptoms of a serious allergic reaction, such as difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.

Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. These can be signs of a rare and potentially fatal side effect (NMS) that has been reported with SAPHRIS and similar medicines. Treatment should be stopped if you have NMS.

Also tell your healthcare provider if:

• You have or had low white blood cell counts, because low white blood cell counts and related conditions have been reported with SAPHRIS and similar medicines
• You have certain heart conditions such as irregular heartbeats, or take certain medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
• You have a seizure disorder, have had seizures, or have conditions that increase your risk for seizures
• You are taking or plan to take prescription and over-the-counter medicines, because there is a risk for drug interactions with SAPHRIS
• You have thoughts of suicide or of hurting yourself or others. Symptoms of bipolar I disorder or schizophrenia may include these thoughts. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away
• You have or have had swallowing problems, because SAPHRIS and medicines like it have been associated with swallowing problems
• You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
• You are pregnant or planning to get pregnant while taking SAPHRIS

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for Prescribing Information, including the Boxed Warning about increased risk of death in elderly people with dementia-related psychosis (a severe mental health problem), and discuss it with your healthcare provider.

This site is intended only for residents of the United States, its territories, and Puerto Rico.

SAPHRIS is a registered trademark of N.V. Organon, a subsidiary of Merck & Co., Inc.

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