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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.In Summary
Common side effects of Saphris include: akathisia, drowsiness, extrapyramidal reaction, headache, and dizziness. Other side effects include: gastric hypersecretory conditions, hypoesthesia, sialorrhea, and weight gain. See below for a comprehensive list of adverse effects.For the Consumer
Applies to asenapine: sublingual tablet
Sublingual route (Tablet)
Use of antipsychotic drugs increases the risk of death in elderly patients with dementia-related psychosis. Asenapine is not approved for treatment of patients with dementia-related psychosis.
Along with its needed effects, asenapine (the active ingredient contained in Saphris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking asenapine:
Some side effects of asenapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to asenapine: sublingual tabletGeneral
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.Nervous system
Somnolence occurred in up to 53% of patients aged 10 to 17 years given 5 mg orally 2 times a day.
Extrapyramidal symptoms occurred in 25% of patients given 10 mg, compared to 11% of patients given 5 mg.
Very common (10% or greater): Somnolence (up to 53%), extrapyramidal symptoms (up to 25%), sedation (up to 19.2%), akathisia (up to 15%), headache (up to 11%), dizziness (up to 10.1%)
Common (1% to 10%): Dysgeusia, dyskinesia, dystonia/acute dystonia, extrapyramidal disorder, parkinsonism, tremor
Uncommon (0.1% to 1%): Dysarthria, restless leg syndrome, seizure, syncope
Rare (less than 0.1%): Neuroleptic malignant syndrome
Frequency not reported: Bradykinesia, cerebrovascular events, hyperkinesia, hypersomnia, lethargy, motor impairment, myoclonus, resting tremor, tardive dyskinesiaGastrointestinal
Oral hypoesthesia occurred in up to 30% of pediatric patients and up to 24% of adults.
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.
Very common (10% or greater): Oral hypoesthesia (up to 30%), oral paresthesia (up to 11%)
Common (1% to 10%): Abdominal pain, constipation, dry mouth, dyspepsia, glossodynia, nausea, oropharyngeal pain, salivary hypersecretion, stomach discomfort, toothache, vomiting
Uncommon (0.1% to 1%): Dysphagia, gastroesophageal reflux disease (GERD/GORD), oromucosal lesions (ulcerations, blustering, inflammation), swollen tongue
Postmarketing reports: Abdominal discomfort, abdominal pain lower, abdominal pain upper, oral dysesthesia, oral peeling/sloughing, oromandibular dystonia, oropharyngeal muscular dysfunction, pharyngeal edema, swallowing difficulty, swollen throat, tongue disorder, tongue protrusionPsychiatric
Very common (10% or greater): Insomnia (up to 16%)
Common (1% to 10%): Agitation, anger, anxiety, bipolar disorder, bipolar I disorder, depression, depressive symptoms, irritability, mania, schizophrenia, suicidal ideation
Frequency not reported: Cognitive impairmentOther
Very common (10% or greater): Fatigue (up to 14%)
Uncommon (0.1% to 1%): Fall
Rare (less than 0.1%): Idiosyncratic drug reaction
Frequency not reported: Body temperature dysregulation, neonatal drug withdrawal syndromeMetabolic
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.
Very common (10% or greater): Weight gain of at least 7% (up to 13.1%)
Common (1% to 10%): Dehydration, hyperinsulinemia, increased appetite, new-onset metabolic syndrome, weight increased
Uncommon (0.1% to 1%): Hyperglycemia, hyponatremia
Frequency not reported: Blood insulin increased, diabetes mellitus, dyslipidemia, metabolic changesMusculoskeletal
Very common (10% or greater: Creatine kinase elevations (up to 11.1%)
Common (1% to 10%): Arthralgia, muscle rigidity, muscle strain, myalgia
Frequency not reported: Involuntary muscle contractions, muscle spasms, muscle twitching, musculoskeletal stiffness, neck muscle spasmCardiovascular
Common (1% to 10%): Edema, hypertension, orthostatic hypotension, peripheral edema, tachycardia
Uncommon (0.1% to 1%): Bundle branch block, hypotension, QT prolongation on ECG, sinus bradycardia, sinus tachycardia, temporary bundle branch block
Frequency not reported: Heart rate increased
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.Hepatic
Common (1% to 10%): ALT increased, AST increased, angioedema, transient asymptomatic elevations in hepatic 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 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 treated patients versus 1.3% for placebo treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in transaminase levels for 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 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.Respiratory
Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis
Rare (less than 0.1%): Pulmonary embolism
Frequency not reported: Difficulty breathing, throat tightness, upper respiratory tract infection
Postmarketing reports: Choking, wheezingGenitourinary
Common (1% to 10%): Dysmenorrhea
Uncommon (0.1% to 1%): Amenorrhea, enuresis, sexual dysfunction
Rare (less than 0.1%): GalactorrheaDermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Photosensitivity reactionOcular
Uncommon (0.1% to 1%): Accommodation disorder, blurred vision, diplopia
Frequency not reported: Blepharospasm, oculogyrationHematologic
Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Neutropenia, thrombocytopenia
Frequency not reported: Agranulocytosis, leukopeniaEndocrine
Uncommon (0.1% to 1%): Decreased prolactin levels
Rare (less than 0.1%): Gynecomastia
Frequency not reported: HyperprolactinemiaHypersensitivity
Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylactic/anaphylactoid reactions, serious hypersensitivity reactionsLocal
Postmarketing reports: Sublingual application site reactions
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