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)
Overweight14.03.02.0210.015651%Not Available
Prolactin-producing pituitary tumour16.24.07.001; 05.03.05.0050.009391%Not Available
Pyomyositis11.02.01.047; 15.05.01.0090.006260%Not Available
Slow response to stimuli17.02.05.0630.009391%Not Available
Soliloquy19.05.01.0210.015651%Not Available
Upper extremity mass15.03.01.0160.012521%Not Available
Consciousness fluctuating17.02.04.0190.006260%Not Available
Impaired self-care19.01.02.014; 08.01.03.0710.006260%Not Available
Sopor19.02.04.002; 17.02.04.021--Not Available
General physical condition abnormal13.15.01.0400.006260%Not Available
Foetal malformation03.02.01.012; 18.03.02.0160.001633%Not Available
Communication disorder19.19.01.0080.018781%Not Available
Disturbance in social behaviour19.05.01.0180.043823%Not Available
Papilloma viral infection11.05.07.0050.006260%Not Available
Antipsychotic drug level increased13.17.01.0300.006260%Not Available
Tachyphrenia19.10.03.010; 17.03.03.0070.009391%Not Available
Excessive eye blinking17.17.02.010; 06.05.01.0040.009391%Not Available
Schizoaffective disorder bipolar type19.03.02.0030.006260%Not Available
Decreased eye contact19.01.02.012; 17.02.05.0550.006260%Not Available
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