Medications and Drugs

Brand Names: Saphris

Generic Name: asenapine (Pronunciation: a SEN a peen)

What is asenapine (Saphris)?

Asenapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Asenapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults.

Asenapine may also be used for purposes not listed in this medication guide.

Saphris 10 mg

round, white, imprinted with 10

Saphris 5 mg

round, white, imprinted with 5

What are the possible side effects of asenapine (Saphris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using asenapine and call your doctor at once if you have any of these serious side effects:

very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
tremor (uncontrolled shaking);
trouble swallowing;
sudden numbness or weakness, especially on one side of the body;
sudden and severe headache, or problems with vision, speech, or balance;
easy bruising or bleeding, fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips;
seizure (convulsions); or
unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself.

Less serious side effects may include:

dizziness, drowsiness;
restless feeling;
numbness or tingling inside or around your mouth;
constipation;
dry mouth;
sleep problems (insomnia);
upset stomach; or
weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about asenapine (Saphris)?

Asenapine is not for use in psychotic conditions related to dementia. Asenapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

While you are taking asenapine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking asenapine.

Asenapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking asenapine, tell your doctor if you have liver disease, heart disease, high blood pressure, seizures, low white blood cell counts, diabetes, trouble swallowing, or a history of breast cancer, heart attack, stroke, or "Long QT syndrome."

Drinking alcohol can increase some of the side effects of asenapine.

Stop taking asenapine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

What should I discuss with my healthcare provider before taking asenapine (Saphris)?»

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.