Saphris Side Effects

Generic name: asenapine

Note: This document contains side effect information about asenapine. Some of the dosage forms listed on this page may not apply to the brand name Saphris.

Some side effects of Saphris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to asenapine: sublingual tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking asenapine (the active ingredient contained in Saphris) 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 of asenapine 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.

For Healthcare Professionals

Applies to asenapine: sublingual tablet

Nervous system

Nervous system side effects including somnolence (up to 24%), extrapyramidal symptoms excluding akathisia (up to 12%), headache (up to 12%), dizziness (up to 11%), dysgeusia (up to 3%), neuroleptic malignant syndrome, and dysarthria have been reported.

Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. There is an elevated risk of acute dystonia in males and younger age groups.

Psychiatric

Psychiatric side effects including insomnia (up to 16%), anxiety (up to 4%), and depression (up to 2%) have been reported.

Gastrointestinal

Gastrointestinal side effects including constipation (up to 7%), oral hypoesthesia (up to 7%), vomiting (up to 7%), salivary hypersecretion (up to 4%), dyspepsia (up to 4%), stomach discomfort (up to 3%), dry mouth (up to 3%), toothache (3%), oral paraesthesia, glossodynia, and swollen tongue have been reported.

General

General side effects including increased weight (up to 5%), fatigue (up to 4%), and irritability (up to 2%) have been reported.

Metabolic

Metabolic side effects including increased appetite (up to 4%) and hyponatremia have been reported.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, or hyperosmolar coma, or death has been reported in patients treated with atypical antipsychotics. In clinical trials of asenapine (the active ingredient contained in Saphris) the occurrence of any adverse reaction related to glucose metabolism was less than 1% in both the asenapine and placebo treatment groups.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 3%) and pain in extremity ( up to 2%) have been reported.

Hepatic

Transient elevations in serum transaminases (primarily ALT) in the short-term schizophrenia and bipolar mania trials were more common in treated patients but mean changes were not clinically relevant. In short-term, placebo-controlled schizophrenia trials, the mean increase in transaminase levels for asenapine (the active ingredient contained in Saphris) treated patients was 1.6 units/L compared to a decrease of 0.4 units/L for placebo treated patients. The proportion of patients with transaminase elevations three or more times the ULN (at the endpoint) was 0.9% for asenapine treated patients versus 1.3% for placebo treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in transaminase levels for asenapine treated patients was 8.9 units/L compared to a decrease of 4.9 units/L in placebo treated patients. The proportion of patients with transaminase elevations three or more times the ULN (at the endpoint) was 2.5% for asenapine treated patients versus 0.6% for placebo treated patients. No cases of more severe liver injury were seen. In a 52 week, double-blind, comparator controlled trial of patients with schizophrenia and schizoaffective disorder, the mean increase from baseline of ALT was 1.7 units/L.

Hepatic side effects including transient elevations in serum transaminase have been reported.

Hematologic

Hematologic side effects including thrombocytopenia and anemia have been reported.

Cardiovascular

Cardiovascular side effects including tachycardia and temporary bundle branch block have been reported.

Four normal volunteers in clinical studies treated with asenapine (the active ingredient contained in Saphris) experienced hypotension, bradycardia, and sinus pauses.

Ocular

Ocular side effects including accommodation disorder have been reported.

Hypersensitivity

Hypersensitivity side effects including idiosyncratic drug reaction have been reported. Post marketing reports have included anaphylaxis and angioedema. In several cases, these reactions occurred after the first dose. These hypersensitivity reactions included: hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.

Other

Other side effects have included oral hypoesthesia and/or oral paraesthesia.

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