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)
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.0050.006260%Not Available
Drooling17.02.05.0050.147121%Not Available
Drug abuse19.07.02.0100.039196%Not Available
Drug dependence19.07.02.009--Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Drug hypersensitivity10.01.01.001--Not Available
Drug withdrawal syndrome19.07.02.011; 08.06.02.004--Not Available
Drug withdrawal syndrome neonatal19.07.02.012; 18.04.13.001; 08.06.02.008--Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.0020.053214%
Dry skin23.03.03.001--
Dysarthria19.19.03.001; 17.02.08.0010.043823%
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.0060.150252%
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dysphonia17.02.08.004; 22.02.05.005; 19.19.03.002--
Dyspnoea22.02.01.004; 02.01.03.002--
Dystonia17.01.03.0010.256680%Not Available
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Ear infection11.01.05.001; 04.03.01.006--Not Available
Ear pain04.03.01.003--
Eating disorder19.09.01.008; 14.03.01.008--Not Available
Eczema23.03.04.006--
Ejaculation delayed21.03.01.0010.006260%Not Available
Ejaculation disorder21.03.01.002--
Ejaculation failure21.03.01.0030.034433%Not Available
Electrocardiogram abnormal13.14.05.001--Not Available
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