Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paliperidone
Drug ID BADD_D01656
Description Paliperidone is the primary active metabolite of risperidone. The mechanism of action is unknown but it is likely to act via a similar pathway to risperidone. It has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism. Paliperidone is also active as an antagonist at alpha 1 and alpha 2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. Paliperidone was approved by the FDA for treatment of schizophrenia on December 20, 2006. It is available as an extended-release tablet, a once-monthly intramuscular injection, an every-three-month intramuscular injection, and a twice-yearly gluteal injection.[L16168,L37744,L4137,L37749]
Indications and Usage For the treatment of schizophrenia.
Marketing Status Prescription; Discontinued
ATC Code N05AX13
DrugBank ID DB01267
KEGG ID D05339
MeSH ID D000068882
PubChem ID 115237
TTD Drug ID D0B3UJ
NDC Product Code 16714-867; 0591-3694; 42292-026; 16714-866; 27808-223; 14593-855; 65691-0072; 0378-3979; 61730-0008; 10147-0951; 16714-869; 62756-502; 0591-3692; 27808-224; 65162-282; 50458-550; 59651-475; 65162-281; 42292-027; 10147-0954; 0904-6936; 43975-352; 55111-925; 50458-552; 47335-765; 53747-039; 0904-6937; 27808-225; 16714-868; 43975-349; 24196-154; 66039-872; 65372-1144; 65015-736; 10147-0953; 60687-470; 43975-350; 10147-0952; 47335-744; 14501-0051; 65267-201; 65162-280; 50458-551; 27808-222; 0378-3980; 0378-3981; 60687-459; 47335-767; 43975-351; 53104-7718; 0591-3693; 50458-554; 42292-055; 65162-283; 0904-6935; 47335-766; 0378-3978; 0591-3695
Synonyms Paliperidone Palmitate | Palmitate, Paliperidone | Paliperidone | 9-OH-risperidone | 9 OH risperidone | 3-(2-(4-(6-fluoro-3-(1,2-benzisoxazolyl))-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido(1,2-a)pyrimidin-4-one | 9-Hydroxy-risperidone | 9 Hydroxy risperidone | 9-Hydroxyrisperidone | 9 Hydroxyrisperidone | Invega | Invega Sustenna | Sustenna, Invega | R 76477 | R-76477 | R76477
Chemical Information
Molecular Formula C23H27FN4O3
CAS Registry Number 144598-75-4
SMILES CC1=C(C(=O)N2CCCC(C2=N1)O)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Feeling jittery08.01.09.0160.015651%Not Available
Feeling of despair19.15.02.0060.009391%Not Available
Flat affect19.04.01.0040.059475%Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Formication19.10.02.010; 17.02.06.0180.006260%Not Available
Fracture15.08.02.001; 12.04.02.0010.025042%
Gait disturbance17.02.05.016; 08.01.02.002--
Galactorrhoea05.03.04.002; 21.05.02.0020.873338%Not Available
Gamma-glutamyltransferase increased13.03.01.011--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.012521%
Generalised tonic-clonic seizure17.12.01.002--Not Available
Glaucoma06.03.01.002--
Glycosuria20.02.01.005--
Glycosylated haemoglobin increased13.02.02.0050.034433%Not Available
Granulocytopenia01.02.03.003--Not Available
Gynaecomastia21.05.04.003; 05.05.02.0030.350587%
Haematocrit decreased13.01.05.001--Not Available
Haematoma24.07.01.001--
Hallucination19.10.02.0020.281722%
Hallucination, auditory19.10.02.0030.472667%Not Available
Hallucination, visual19.10.02.0040.043823%Not Available
Hallucinations, mixed19.10.02.0070.025042%Not Available
Head discomfort17.02.05.027--Not Available
Headache17.14.01.001--
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