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Saphris Side Effects

Generic Name: asenapine

Note: This page contains side effects data for the generic drug asenapine. It is possible that some of the dosage forms included below may not apply to the brand name Saphris.

It is possible that some side effects of Saphris may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to asenapine: sublingual tablet

As well as its needed effects, asenapine (the active ingredient contained in Saphris) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking asenapine, check with your doctor immediately:

More common
  • Abnormal or decreased touch sensation
  • inability to move the eyes
  • inability to sit still
  • increase in body movements
  • increased blinking or spasms of the eyelid
  • lip smacking or puckering
  • need to keep moving
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • sticking out of tongue
  • trembling or shaking of the hands or feet
  • trouble with breathing, speaking, or swallowing
  • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled chewing movements
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
  • weakness of the arms and legs
Less common
  • Blurred vision
  • dizziness
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
Rare
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in patterns and rhythms of speech
  • coma
  • confusion
  • convulsions
  • decreased urine output
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • muscle pain or cramps
  • nausea or vomiting
  • pale skin
  • pinpoint red spots on the skin
  • slurred speech
  • swelling of the face, ankles, or hands
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some asenapine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Constipation
  • sleepiness or unusual drowsiness
  • trouble sleeping
  • unusually deep sleep
  • unusually long duration of sleep
Less common
  • Acid or sour stomach
  • belching
  • depression
  • difficulty with moving
  • dry mouth
  • fear or nervousness
  • heartburn
  • increased appetite
  • increased watering of the mouth
  • increased weight
  • indigestion
  • irritability
  • muscle pain or stiffness
  • pain in the arms or legs
  • pain in the joints
  • stomach discomfort, upset, or pain
  • toothache

For Healthcare Professionals

Applies to asenapine: sublingual tablet

General

The most commonly reported adverse reactions in adults included akathisia, dizziness, extra pyramidal symptoms other than akathisia, oral hypoesthesia, somnolence, and increased weight. The most commonly reported adverse reactions in pediatric patients included somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, and increased weight.[Ref]

Cardiovascular

In a dedicated QT study in patients with schizophrenia, doses of 5, 10, 15, and 20 mg twice a day were compared with placebo. QTc interval increases ranged from 2 to 5 msec. No patients had QTc increases of 60 msec or greater, nor did any patient experience a QTc of 500 msec or greater.

Orthostatic hypotension was reported in 4.1% of elderly subjects compared with 0.3% in the combined study populations.[Ref]

Common (1% to 10%): Hypertension, edema
Uncommon (0.1% to 1%): Syncope, sinus bradycardia, bundle branch block, QT prolongation on ECG, sinus tachycardia, orthostatic hypotension, hypotension
Rare (less than 0.1%): Tachycardia[Ref]

Metabolic

While all atypical antipsychotics have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain, the degree of metabolic change differs for each agent.

In clinical trials with this drug, changes from baseline in fasting glucose ranged from -0.6 to 3.8 mg/dL in adults and -0.45 to 1.43 mg/dL in pediatric patients treated with this drug for 3 to 6 weeks compared with -0.2 and -2.24 mg/dL in adults and pediatric patients receiving placebo, respectively. In a 52-week double-blind, comparator-controlled trial in primarily schizophrenic patients, the mean increase in fasting glucose from baseline was 2.4 mg/dL.

An increase of 7% or more in body weight occurred in 8% to 12% of adults and 4.4% to 4.8% of pediatric patients treated with this drug for 3 weeks compared with 1.1% and 1.6%, respectively in adults and pediatric patients receiving placebo. In a 52-week double-blind, comparator-controlled trial in primarily schizophrenic patients, the mean increase in weight from baseline was 0.9 kg.[Ref]

Common (1% to 10%): Weight increased, increased appetite
Uncommon (0.1% to 1%): Hyponatremia, hyperglycemia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Neutropenia, thrombocytopenia[Ref]

Endocrine

Common (1% to 10%): Dysmenorrhea
Uncommon (0.1% to 1%): Sexual dysfunction, amenorrhea
Rare (less than 0.1%): Gynecomastia, galactorrhea
Frequency not reported: Hyperprolactinemia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity to include anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, agitation, depression, irritability, suicidal ideation, anger[Ref]

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.[Ref]

Common (1% to 10%): Alanine aminotransferase (ALT) increased[Ref]

Musculoskeletal

Common (1% to 10%): Muscle rigidity, arthralgia, extremity pain
Rare (less than 0.1%): Rhabdomyolysis[Ref]

Nervous system

Very common (10% or greater): Somnolence (pediatric patients; up to 53%)
Common (1% to 10%): Dizziness, somnolence (adults), extrapyramidal disorder, akathisia, dyskinesia, dystonia, parkinsonism, sedation, dysgeusia, tremor, headache, dysgeusia, akathisia
Uncommon (0.1% to 1%): Seizure, dysarthria,
Rare (less than 0.1%): Neuroleptic malignant syndrome
Frequency not reported: Restless leg syndrome[Ref]

Ocular

Rare (less than 0.1%): Accommodation disorder[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis, asthma, rhinorrhea, sinus congestion, nasal dryness
Rare (less than 0.1%): Pulmonary embolism
Postmarketing: Choking[Ref]

Gastrointestinal

Very common (10% or greater): Oral paraesthesia (pediatrics, up to 30%)
Common (1% to 10%): Constipation, dry mouth, oral hypoesthesia (adults), salivary hypersecretion, stomach discomfort, vomiting, toothache, dyspepsia, diarrhea, nausea, abdominal pain
Uncommon (0.1% to 1%): Dysphagia, swollen tongue, glossodynia
Postmarketing reports: Oral ulcers, blisters, peeling/sloughing, and inflammation at the application site, nausea[Ref]

Application site reactions that include oral ulcers, blisters, peeling/sloughing, and inflammation primarily in the sublingual area have led to discontinuation of therapy in many cases. Oral hypoesthesia and/or oral paraesthesia may occur directly after administration and usually resolve in 1 hour.[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Saphris (asenapine)." Schering-Plough Corporation, Kenilworth, NJ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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