Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Risperidone
Drug ID BADD_D01951
Description Risperidone is a second-generation antipsychotic (SGA) medication used in the treatment of a number of mood and mental health conditions including schizophrenia and bipolar disorder.[L12885] It is one of the most widely used SGAs. [Paliperidone], another commonly used SGA, is the primary active metabolite of risperidone (i.e. 9-hydroxyrisperidone).[L12885] Schizophrenia and various mood disorders are thought to be caused by an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively.[L1212,L1213] Risperidone is thought to reduce this overactivity through inhibition of dopaminergic D2 receptors and serotonergic 5-HT2A receptors in the brain.[L1213,A1115] Risperidone binds with a very high affinity to 5-HT2A receptors, approximately 10-20 fold greater than the drug's binding affinity to D2 receptors,[L1212,L1213,A1115] and carries lesser activity at several off-targets which may responsible for some of its undesirable effects.[L12885]
Indications and Usage Risperidone is indicated for the treatment of schizophrenia and irritability associated with autistic disorder.[L12885] It is also indicated as monotherapy, or adjunctly with lithium or valproic acid, for the treatment of acute mania or mixed episodes associated with bipolar I disorder.[L12885] Risperidone is additionally indicated in Canada for the short-term symptomatic management of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to nonpharmacological approaches.[L12906] Risperidone is also used off-label for a number of conditions including as an adjunct to antidepressants in treatment-resistant depression.[A177226]
Marketing Status approved; investigational
ATC Code N05AX08
DrugBank ID DB00734
KEGG ID D00426
MeSH ID D018967
PubChem ID 5073
TTD Drug ID D01AZG
NDC Product Code 12578-303; 57451-1185; 64567-0003; 65757-728; 65862-365; 12496-0090; 13668-035; 13668-039; 50458-306; 50458-325; 51759-410; 55700-897; 59746-050; 65841-670; 68071-2706; 68084-277; 69238-2108; 70518-1613; 70518-2969; 70518-3741; 71610-045; 71610-246; 0615-8197; 0615-8265; 0904-6360; 63552-180; 42291-913; 49884-315; 51759-850; 55154-4161; 59746-010; 63304-950; 63629-2283; 68084-271; 68382-154; 69238-2113; 70518-1151; 55111-869; 65267-895; 65757-727; 27241-004; 27241-005; 27241-006; 42291-908; 50458-335; 50458-355; 51759-305; 51759-520; 58118-0077; 59746-040; 63629-2284; 65841-642; 65841-668; 0054-0063; 68084-270; 70518-0364; 70518-3087; 70518-3760; 55154-3361; 55154-5899; 63187-264; 63187-642; 63304-643; 65862-167; 68084-273; 71335-0130; 0615-8196; 0904-6358; 71161-131; 27241-003; 49884-403; 50458-302; 50458-308; 51759-960; 63187-439; 68382-155; 70518-1502; 71205-520; 71335-0626; 0904-6361; 65757-725; 13668-037; 27808-002; 43063-908; 43547-344; 49884-311; 49884-401; 54838-563; 59746-030; 63304-951; 65841-641; 65841-667; 68084-272; 70518-1574; 70518-1771; 71610-259; 0615-8198; 72526-102; 72526-104; 63415-0037; 63552-179; 64220-119; 64552-4011; 42291-911; 43547-343; 49884-402; 50458-300; 50458-315; 50458-395; 51759-630; 53002-1596; 65841-640; 65841-666; 68084-274; 68382-114; 68382-115; 70518-1575; 71610-264; 53104-7555; 65015-619; 65757-726; 65841-122; 12496-0120; 42291-909; 43063-254; 43353-412; 43353-720; 43547-339; 49884-212; 50090-3340; 50458-309; 50458-350; 51759-740; 59746-020; 62135-929; 63304-949; 68382-156; 70518-1568; 70518-1763; 71335-0459; 71335-0740; 0615-8288; 72526-103; 52038-007; 65372-1105; 27241-002; 43547-340; 43547-341; 43547-342; 50090-3344; 50458-305; 50458-307; 50458-596; 63187-418; 65162-673; 65841-669; 69238-2110; 70518-2130; 70518-3104; 0904-6359; 0904-6362; 13668-036; 13668-038; 27241-001; 42291-910; 42291-912; 43353-432; 50090-3341; 50458-320; 50458-330; 63304-644; 65841-665; 68382-112; 68382-113; 68382-116; 68382-117; 69238-2109; 69238-2111; 69238-2112; 70518-0978; 72162-2037; 72526-101; 0904-6357; 40700-0031; 46602-0050; 65267-303; 71161-132; 13668-040
UNII L6UH7ZF8HC
Synonyms Risperidone | Risperdal Consta | Consta, Risperdal | Risperidal | R-64,766 | R 64,766 | R64,766 | R-64766 | R 64766 | R64766
Chemical Information
Molecular Formula C23H27FN4O2
CAS Registry Number 106266-06-2
SMILES CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood pressure decreased13.14.03.002--Not Available
Blood prolactin increased13.10.03.002--Not Available
Blood testosterone decreased13.10.05.004--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Blood uric acid increased13.02.04.001--Not Available
Blunted affect19.04.01.0030.000546%Not Available
Body temperature decreased13.15.01.010--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.0020.002897%Not Available
Bradykinesia17.01.02.0040.001055%Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast cyst21.05.01.006; 16.14.01.0040.000388%Not Available
Breast discharge21.05.05.0010.002655%Not Available
Breast engorgement18.08.02.001; 21.05.05.002--Not Available
Breast enlargement21.05.04.0010.007407%Not Available
Breast feeding26.05.01.001--Not Available
Breast inflammation21.05.03.0010.000121%Not Available
Breast mass21.05.04.0020.000982%Not Available
Breast oedema21.05.05.0120.000121%Not Available
Breast pain21.05.05.0030.000982%
Breast swelling21.05.05.0080.000800%Not Available
Breast tenderness21.05.05.0040.000921%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Bruxism19.11.03.001; 07.01.06.0080.000412%Not Available
Bundle branch block02.03.01.0090.000121%Not Available
Bundle branch block left02.03.01.0070.000121%Not Available
Bundle branch block right02.03.01.0110.000727%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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