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Saphris

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Saphris

Saphris

Saphris Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Saphris (asenapine) is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). It is a psychiatric medication in the class of drugs called atypical antipsychotics. Common side effects include drowsiness, dizziness, numbness of the mouth, and weight gain.

Saphris is a sublingual (under the tongue) tablet. Dosage is individualized to the patient's need and response to treatment. The usual dose ranges from 5 to 10 mg taken twice daily. Saphris may interact with alpha blockers, anticholinergic/antispasmodic drugs, fluvoxamine, paroxetine, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, antibiotics, alcohol, antihistamines, theophylline, tramadol, antidepressants, drugs for sleep or anxiety, muscle relaxants, and narcotics. Check labels of allergy or cough-and-cold products for ingredients that cause drowsiness. Tell your doctor all medications you are taking. During pregnancy, Saphris should be used only when prescribed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice these symptoms in your newborn during their first month, tell the doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Saphris (asenapine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Saphris in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Saphris (Asenapine Sublingual Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Saphris Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, and weight gain may occur. Numbness/tingling of the mouth may also occur but usually goes away within 1 hour. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor immediately if you notice any of the following side effects: feelings of anxiety/agitation/jitteriness, drooling/trouble swallowing, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), mask-like expression of the face.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.

This drug may rarely make your blood sugar level rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.

In rare cases, asenapine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Rarely, with similar drugs, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these rare but serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.

This drug may rarely cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome-NMS). Seek immediate medical attention if you notice any of the following side effects: fever, stiff muscles, increased sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Saphris (Asenapine Sublingual Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Saphris FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Overall Adverse Reactions Profile

The following adverse reactions are discussed in more detail in other sections of the labeling:

The most common adverse reactions ( ≥ 5% and at least twice the rate of placebo) reported with acute treatment in schizophrenia were akathisia, oral hypoesthesia, and somnolence. The safety profile of SAPHRIS in the maintenance treatment of schizophrenia was similar to that seen with acute treatment.

The most common adverse reactions ( ≥ 5% and at least twice the rate of placebo) reported with acute monotherapy treatment of manic or mixed episodes associated with bipolar I disorder were somnolence, dizziness, extrapyramidal symptoms other than akathisia, and weight increased and during the adjunctive therapy trial in bipolar disorder were somnolence and oral hypoesthesia.

The information below is derived from a clinical trial database for SAPHRIS consisting of over 4565 patients and/or normal subjects exposed to one or more sublingual doses of SAPHRIS. A total of 1314 SAPHRIS-treated patients were treated for at least 24 weeks and 785 SAPHRIS-treated patients had at least 52 weeks of exposure at therapeutic doses.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced a treatment-emergent adverse event of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

The figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment, uses, and investigators. The cited figures, however, do provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse reaction incidence in the population studied.

Clinical Studies Experience

Adult Patients with Schizophrenia

The following findings are based on the short-term placebo-controlled pre-marketing trials for schizophrenia (a pool of three 6-week fixed-dose trials and one 6-week flexible-dose trial) in which sublingual SAPHRIS was administered in doses ranging from 5 to 10 mg twice daily.

Adverse Reactions Associated with Discontinuation of Treatment: A total of 9% of SAPHRIS-treated subjects and 10% of placebo subjects discontinued due to adverse reactions. There were no drug-related adverse reactions associated with discontinuation in subjects treated with SAPHRIS at the rate of at least 1% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in SAPHRIS-Treated Schizophrenic Patients: Adverse reactions associated with the use of SAPHRIS (incidence of 2% or greater, rounded to the nearest percent, and SAPHRIS incidence greater than placebo) that occurred during acute therapy (up to 6-weeks in patients with schizophrenia) are shown in Table 2.

Table 2: Adverse Reactions Reported in 2% or More of Subjects in One of the SAPHRIS Dose Groups and Which Occurred at Greater Incidence Than in the Placebo Group in 6-Week Schizophrenia Trials

System Organ Class/ Preferred Term Placebo
N=378
SAPHRIS 5 mg twice daily
N=274
SAPHRIS 10 mg twice daily
N=208
All SAPHRIS§ 5 mg or 10 mg twice daily
N=572
Gastrointestinal disorders
  Constipation 6% 7% 4% 5%
  Dry mouth 1% 3% 1% 2%
  Oral hypoesthesia 1% 6% 7% 5%
  Salivary hypersecretion 0% < 1% 4% 2%
  Stomach discomfort 1% < 1% 3% 2%
  Vomiting 5% 4% 7% 5%
General disorders
  Fatigue   3% 4% 3% 3%
  Irritability < 1% 2% 1% 2%
Investigations
  Weight increased < 1% 2% 2% 3%
Metabolism disorders
  Increased appetite < 1% 3% 0% 2%
Nervous system disorders
  Akathisia* 3% 4% 11% 6%
  Dizziness 4% 7% 3% 5%
  Extrapyramidal symptoms (excluding akathisia)† 7% 9% 12% 10%
  Somnolence‡ 7% 15% 13% 13%
Psychiatric disorders
  Insomnia 13% 16% 15% 15%
Vascular disorders
  Hypertension 2% 2% 3% 2%
* Akathisia includes: akathisia and hyperkinesia.
† Extrapyramidal symptoms included dystonia, oculogyration, dyskinesia, tardive dyskinesia, muscle rigidity, parkinsonism, tremor, and extrapyramidal disorder (excluding akathisia).
‡ Somnolence includes the following events: somnolence, sedation, and hypersomnia.
§ Also includes the Flexible-dose trial (N=90).

Dose-Related Adverse Reactions: Of all the adverse reactions listed in Table 2, the only apparent dose-related adverse reaction was akathisia.

Monotherapy in Adult Patients with Bipolar Mania

The following findings are based on the short-term placebo-controlled trials for bipolar mania (a pool of two 3-week flexible-dose trials) in which sublingual SAPHRIS was administered in doses of 5 mg or 10 mg twice daily.

Adverse Reactions Associated with Discontinuation of Treatment: Approximately 10% (38/379) of SAPHRIS-treated patients in short-term, placebo-controlled trials discontinued treatment due to an adverse reaction, compared with about 6% (12/203) on placebo. The most common adverse reactions associated with discontinuation in subjects treated with SAPHRIS (rates at least 1% and at least twice the placebo rate) were anxiety (1.1%) and oral hypoesthesia (1.1%) compared to placebo (0%).

Adverse Reactions Occurring at an Incidence of 2% or More Among SAPHRIS-Treated (Monotherapy) Bipolar Patients: Adverse reactions associated with the use of SAPHRIS (incidence of 2% or greater, rounded to the nearest percent, and SAPHRIS incidence greater than placebo) that occurred during acute monotherapy (up to 3-weeks in patients with bipolar mania) are shown in Table 3.

Table 3: Adverse Reactions Reported in 2% or More of Subjects in One of the SAPHRIS Dose Groups and Which Occurred at Greater Incidence Than in the Placebo Group in 3-Week Bipolar Mania Trials

System Organ Class/Preferred Term Placebo
N=203
SAPHRIS 5 mg or 10 mg twice daily*
N=379
Gastrointestinal disorders
  Dry mouth 1% 3%
  Dyspepsia 2% 4%
  Oral hypoesthesia < 1% 4%
  Toothache 2% 3%
General disorders
  Fatigue 2% 4%
Investigations
  Weight increased < 1% 5%
Metabolism disorders
  Increased appetite 1% 4%
Musculoskeletal and connective tissue disorders
  Arthralgia 1% 3%
  Pain in extremity < 1% 2%
Nervous system disorders
  Akathisia 2% 4%
  Dizziness 3% 11%
  Dysgeusia < 1% 3%
  Headache 11% 12%
  Other extrapyramidal symptoms (excluding akathisia)† 2% 7%
  Somnolence‡ 6% 24%
Psychiatric disorders
  Anxiety 2% 4%
  Depression 1% 2%
  Insomnia 5% 6%
* SAPHRIS 5 mg to 10 mg twice daily with flexible dosing.
† Extrapyramidal symptoms included: dystonia, blepharospasm, torticollis, dyskinesia, tardive dyskinesia, muscle rigidity, parkinsonism, gait disturbance, masked facies, and tremor (excluding akathisia).
‡ Somnolence includes the following events: somnolence, sedation, and hypersomnia.

Adjunctive Therapy in Adult Patients with Bipolar Mania

The following findings are based on a 12 week placebo-controlled trial (with a 3 week efficacy endpoint) in adult patients with bipolar mania in which sublingual SAPHRIS was administered in doses of 5 mg or 10 mg twice daily as adjunctive therapy with lithium or valproate.

Adverse Reactions Associated with Discontinuation of Treatment: Approximately 16% (25/158) of SAPHRIS-treated patients discontinued treatment due to an adverse reaction, compared with about 11% (18/166) on placebo. The most common adverse reactions associated with discontinuation in subjects treated with SAPHRIS (rates at least 1% and at least twice the placebo rate) were depression (2.5%), suicidal ideation (2.5%), bipolar 1 disorder (1.9%), insomnia (1.9%) and depressive symptoms (1.3%).

Adverse Reactions Occurring at an Incidence of 2% or More Among SAPHRIS-Treated (Adjunctive) Bipolar Patients: Adverse reactions associated with the use of SAPHRIS (incidence of 2% or greater, rounded to the nearest percent, and SAPHRIS incidence greater than placebo) that occurred during acute adjunctive therapy at 3 weeks, a time when most of the patients were still participating in the trial, are shown in Table 4.

Table 4: Adverse Reactions Reported in 2% or More Among SAPHRIS-Treated (Adjunctive) Bipolar Mania Patients and Which Occurred at Greater Incidence Than in the Placebo Group at 3 Weeks

System Organ Class/Preferred Term Placebo
N=166
SAPHRIS 5 mg or 10 mg twice daily*
N=158
Gastrointestinal disorders
  Dyspepsia 2% 3%
  Oral hypoesthesia 0% 5%
General disorders
  Fatigue 2% 4%
  Edema peripheral < 1% 3%
Investigations
  Weight increased 0% 3%
Nervous system disorders
  Dizziness 2% 4%
  Other extrapyramidal symptoms (excluding akathisia)† 5% 6%
  Somnolence‡ 10% 22%
Psychiatric disorders
  Insomnia 8% 10%
Vascular disorders
  Hypertension < 1% 3%
* SAPHRIS 5 mg to 10 mg twice daily with flexible dosing.
† Extrapyramidal symptoms included: dystonia, parkinsonism, oculogyration, and tremor (excluding akathisia).
‡ Somnolence includes the following events: somnolence and sedation.

Dystonia

Antipsychotic Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, 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. An elevated risk of acute dystonia is observed in males and younger age groups.

Extrapyramidal Symptoms

In the short-term, placebo-controlled schizophrenia and bipolar mania trials, data was objectively collected on the Simpson Angus Rating Scale for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (for akathisia) and the Assessments of Involuntary Movement Scales (for dyskinesias). The mean change from baseline for the all-SAPHRIS 5 mg or 10 mg twice daily treated group was comparable to placebo in each of the rating scale scores.

In the short-term, placebo-controlled schizophrenia trials, the incidence of reported EPS-related events, excluding events related to akathisia, for SAPHRIS-treated patients was 10% versus 7% for placebo; and the incidence of akathisia-related events for SAPHRIS-treated patients was 6% versus 3% for placebo. In short-term placebo-controlled bipolar mania trials, the incidence of EPS-related events, excluding events related to akathisia, for SAPHRIS-treated patients was 7% versus 2% for placebo; and the incidence of akathisia-related events for SAPHRIS-treated patients was 4% versus 2% for placebo.

Other Findings

Oral hypoesthesia and/or oral paraesthesia may occur directly after administration of asenapine and usually resolves within 1 hour.

Laboratory Test Abnormalities

Glucose: The effects on fasting serum glucose levels in the short-term schizophrenia and bipolar mania trials revealed no clinically relevant mean changes [see also WARNINGS AND PRECAUTIONS]. In the short-term placebo-controlled schizophrenia trials, the mean increase in fasting glucose levels for SAPHRIS-treated patients was 3.2 mg/dL compared to a decrease of 1.6 mg/dL for placebo-treated patients. The proportion of patients with fasting glucose elevations ≥ 126 mg/dL (at Endpoint), was 7.4% for SAPHRIS-treated patients versus 6% for placebo-treated patients. In the short-term, placebo-controlled bipolar mania trials, the mean decreases in fasting glucose levels for both SAPHRIS-treated and placebo-treated patients were 0.6 mg/dL. The proportion of patients with fasting glucose elevations ≥ 126 mg/dL (at Endpoint), was 4.9% for SAPHRIS-treated patients versus 2.2% for placebo-treated patients.

In a 52-week, double-blind, comparator-controlled trial of patients with schizophrenia and schizoaffective disorder, the mean increase from baseline of fasting glucose was 2.4 mg/dL.

Lipids: The effects on total cholesterol and fasting triglycerides in the short-term schizophrenia and bipolar mania trials revealed no clinically relevant mean changes. In short-term, placebo-controlled schizophrenia trials, the mean increase in total cholesterol levels for SAPHRIS-treated patients was 0.4 mg/dL compared to a decrease of 3.6 mg/dL for placebo-treated patients. The proportion of patients with total cholesterol elevations ≥ 240 mg/dL (at Endpoint) was 8.3% for SAPHRIS-treated patients versus 7% for placebo-treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in total cholesterol levels for SAPHRIS-treated patients was 1.1 mg/dL compared to a decrease of 1.5 mg/dL in placebo-treated patients. The proportion of patients with total cholesterol elevations ≥ 240 mg/dL (at Endpoint) was 8.7% for SAPHRIS-treated patients versus 8.6% for placebo-treated patients. In short-term, placebo-controlled schizophrenia trials, the mean increase in triglyceride levels for SAPHRIS-treated patients was 3.8 mg/dL compared to a decrease of 13.5 mg/dL for placebo-treated patients. The proportion of patients with elevations in triglycerides ≥ 200 mg/dL (at Endpoint) was 13.2% for SAPHRIS-treated patients versus 10.5% for placebo-treated patients. In short-term, placebo-controlled bipolar mania trials, the mean decrease in triglyceride levels for SAPHRIS-treated patients was 3.5 mg/dL versus 17.9 mg/dL for placebo-treated subjects. The proportion of patients with elevations in triglycerides ≥ 200 mg/dL (at Endpoint) was 15.2% for SAPHRIS-treated patients versus 11.4% for placebo-treated patients.

In a 52-week, double-blind, comparator-controlled trial of patients with schizophrenia and schizoaffective disorder, the mean decrease from baseline of total cholesterol was 6 mg/dL and the mean decrease from baseline of fasting triglycerides was 9.8 mg/dL.

Transaminases: 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 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 ≥ 3 times ULN (at Endpoint) was 0.9% for SAPHRIS-treated patients versus 1.3% for placebo-treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in transaminase levels for SAPHRIS-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 ≥ 3 times upper limit of normal (ULN) (at Endpoint) was 2.5% for SAPHRIS-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.

Prolactin: The effects on prolactin levels in the short-term schizophrenia and bipolar mania trials revealed no clinically relevant mean changes in baseline. In short-term, placebo-controlled schizophrenia trials, the mean decreases in prolactin levels were 6.5 ng/mL for SAPHRIS-treated patients compared to 10.7 ng/mL for placebo-treated patients. The proportion of patients with prolactin elevations ≥ 4 times ULN (at Endpoint) were 2.6% for SAPHRIS-treated patients versus 0.6% for placebo-treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in prolactin levels was 4.9 ng/mL for SAPHRIS-treated patients compared to a decrease of 0.2 ng/mL for placebo-treated patients. The proportion of patients with prolactin elevations ≥ 4 times ULN (at Endpoint) were 2.3% for SAPHRIS-treated patients versus 0.7% for placebo-treated patients.

In a long-term (52-week), double-blind, comparator-controlled trial of patients with schizophrenia and schizoaffective disorder, the mean decrease in prolactin from baseline for SAPHRIS-treated patients was 26.9 ng/mL.

Creatine Kinase (CK): The proportion of patients with CK elevations > 3 times ULN at any time were 6.4% and 11.1% for patients treated with SAPHRIS 5 mg bid and 10 mg bid, respectively, as compared to 6.7% for placebo-treated patients in short-term, fixed-dose trials in schizophrenia and bipolar mania. The clinical relevance of this finding is unknown.

Other Adverse Reactions Observed During the Premarketing Evaluation of SAPHRIS

Following is a list of MedDRA terms that reflect adverse reactions reported by patients treated with sublingual SAPHRIS at multiple doses of ≥ 5 mg twice daily during any phase of a trial within the database of adult patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions already listed in other parts of Adverse Reactions (6), or those considered in WARNINGS AND PRECAUTIONS (5) or Overdosage (10) are not included. Although the reactions reported occurred during treatment with SAPHRIS, they were not necessarily caused by it. Reactions are further categorized by MedDRA system organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); those occurring in 1/100 to 1/1000 patients; and those occurring in fewer than 1/1000 patients.

Blood and lymphatic disorders: < 1/1000 patients: thrombocytopenia; ≥ 1/1000 patients and < 1/100 patients: anemia

Cardiac disorders: ≥ 1/1000 patients and < 1/100 patients: tachycardia, temporary bundle branch block

Eye disorders: ≥ 1/1000 patients and < 1/100 patients: accommodation disorder

Gastrointestinal disorders: ≥ 1/1000 patients and < 1/100 patients: oral paraesthesia, glossodynia, swollen tongue

General disorders: < 1/1000 patients: idiosyncratic drug reaction

Investigations: ≥ 1/1000 patients and < 1/100 patients: hyponatremia

Nervous system disorders: ≥ 1/1000 patients and < 1/100 patients: dysarthria

Read the entire FDA prescribing information for Saphris (Asenapine Sublingual Tablets) »

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Saphris - User Reviews

Saphris User Reviews

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