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More information: STITCH, PubChem (stereo-specific compounds: 1, 2) and possibly Wikipedia

ATC Code: N05AH05

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4
Somnolence Somnolence 9.92% - 24% 1.97% - 10% x x x x
Insomnia Insomnia 1.9% - 16% 5% - 13% x x x
Extrapyramidal disorder Extrapyramidal symptoms 6% - 12% 2% - 7% x x x
Extrapyramidal disorder x
Headache Headache 3.99% - 12% 5.45% - 11% x x x
Akathisia Akathisia 4% - 12% 2% - 7% x x x x
Vomiting Vomiting 4% - 7% 5% x x
Hypoaesthesia oral Hypoaesthesia oral 0.263% - 7% 0% - 1% x x x x
Dizziness Dizziness 3% - 11% 2% - 4% x x x x
Syncope x x x
Constipation Constipation 1.55% - 7% 2.63% - 6% x x x
Dyspepsia Dyspepsia 4% 2% x x
Asthenia Fatigue 2.75% - 4.65% 1.69% - 3% x x x x
Fatigue Fatigue 2.75% - 4.65% 1.69% - 3% x x x x
Arthralgia Arthralgia 3% 1% x x
Musculoskeletal discomfort Arthralgia 3% 1% x x
Dysgeusia Dysgeusia 3% 1% x x x
Toothache Toothache 3% 2% x x
Weight increased Weight increased 2% - 18.6% 0% - 0.564% x x x x
Oedema peripheral Oedema peripheral 3% 1% x x
Nausea Nausea 2.55% - 3.36% 3.95% x x
Hypertension Hypertension 2% - 3% 1% - 2% x x
Increased appetite Increased appetite 0% - 4.13% 1% x x x x
Suicidal ideation Suicidal ideation 2.5% x x
Anxiety Anxiety 1.1% - 4% 2% - 2.82% x x x x
Schizophrenia Schizophrenia 1.84% - 2.75% 2.54% x
Parkinsonism Parkinsonism 1.32% - 3.17% 0.94% x
Depression Depression 2% 1% x x
Irritability Irritability 1% - 2% 1% x x
Pain in extremity Pain in extremity 2% 1% x x
Salivary hypersecretion Salivary hypersecretion 1% - 4% 0% x x x x
Dry mouth Dry mouth 1% - 4.74% 1% - 1.41% x x x
Abdominal discomfort Upset stomach 1% - 3% 1% x x
Agitation Agitation 1.32% - 2.41% 2.35% x
Tremor Tremor 1.23% - 2.22% 1.22% x
Alanine aminotransferase increased Alanine aminotransferase increased 1.17% - 2.02% 0.564% x x
Depressive symptom Depressive symptom 1.3% x x
Blister Blister postmarketing x x x
Dermatitis bullous Blister postmarketing x x x
Hypersensitivity Hypersensitivity postmarketing x x x x
Inflammation Inflammation postmarketing x x x
Swelling Swelling postmarketing x x
Stomatitis Mouth ulceration postmarketing x
Mouth ulceration Mouth ulceration postmarketing x
Pharyngeal oedema Pharyngeal oedema postmarketing x x
Swollen tongue Swollen tongue postmarketing x x x x
Skin exfoliation Localized exfoliation postmarketing x
Agranulocytosis Agranulocytosis x x
Amenorrhoea Amenorrhoea x
Anaphylactic shock Anaphylactic shock x
Anaphylactoid reaction x
Anaemia Anaemia x x
Angioedema Angioedema x x
Mental disorder Mental disorder x x x x
Breast disorder Breast disorder x
Bundle branch block Bundle branch block x x x
Connective tissue disorder Connective tissue disorder x x x
Dysphagia Dysphagia x x x
Diabetes mellitus Diabetes mellitus x x
Dysarthria Dysarthria x x x
Osteoarthritis Dysarthria x x x
Dyskinesia Dyskinesia x x x
Movements involuntary x x
Dyspnoea Dyspnoea x x x
Dermatitis Rash x
Rash Rash x
Eye disorder Eye disorder x x x
Gastrointestinal disorder Gastrointestinal disorder x x x x
Glossodynia Glossodynia x x x
Gynaecomastia Gynaecomastia x
Cardiac disorder Cardiac disorder x x x
Blood disorder Blood disorder x x x
Hyperglycaemia Hyperglycaemia x x x
Hyperprolactinaemia Hyperprolactinaemia x x
Hypertriglyceridaemia Hypertriglyceridaemia x x
Blood triglycerides increased Hypertriglyceridaemia x x
Hyponatraemia Hyponatraemia x x
Hypotension Hypotension x x
Orthostatic hypotension Orthostatic hypotension x x x
Immune system disorder Immune system disorder x x
Leukopenia Leukopenia x x
Mediastinal disorder Mediastinal disorder x
Muscle rigidity Muscle rigidity x
Drug withdrawal syndrome neonatal Drug withdrawal syndrome neonatal x
Nervous system disorder Nervous system disorder x x x x
Neuroleptic malignant syndrome Neuroleptic malignant syndrome x x x
Neutropenia Neutropenia x x x
Pregnancy Pregnancy x
Psychotic disorder Psychotic disorder x x
Pulmonary embolism Pulmonary embolism x
Restless legs syndrome Restless legs syndrome x
Rhabdomyolysis Rhabdomyolysis x
Convulsion Convulsion x x x
Muscle spasms Muscle spasms x x
Completed suicide Suicide x x
Shock Syncope x x x
Syncope Syncope x x x
Loss of consciousness Syncope x x x
Tachycardia Tachycardia x x x
Sinus tachycardia Sinus tachycardia x
Thrombocytopenia Thrombocytopenia x x
Ulcer Ulcer x x
Angiopathy Angiopathy x x x
Wheezing Wheezing x
Sinus bradycardia Sinus bradycardia x
Electrocardiogram QT prolonged Electrocardiogram QT prolonged x
Accommodation disorder Accommodation disorder x x x
Liver injury Liver injury x x
Traumatic liver injury Liver injury x x
Malnutrition Malnutrition x x
Malaise Sickness x x
Galactorrhoea Galactorrhoea x
Throat tightness Throat tightness x x
Hepatobiliary disease Hepatobiliary disease x
Anaphylactoid reaction Anaphylactoid reaction x
Paraesthesia oral Paraesthesia oral x x x x
Sexual dysfunction Sexual dysfunction x
Tardive dyskinesia Tardive dyskinesia x x
Blood prolactin increased Increased prolactin level x x
Idiosyncratic drug reaction Idiosyncratic drug reaction x x
Blood cholesterol increased High cholesterol x x


Information about indications was extracted from the indications and usage sections of the labels.

asenapine maleate / SAPHRIS

Side effects:37

asenapine / asenapine maleate 

Side effects:63


Side effects:73
Source:FDA Structured Product Label


Side effects:75
Source:FDA Structured Product Label

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label