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)
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anhedonia19.15.02.007--Not Available
Anorgasmia19.08.01.0010.012521%
Anticholinergic syndrome17.05.01.0010.009391%Not Available
Antisocial behaviour19.05.01.0100.012521%Not Available
Anxiety19.06.02.0020.297373%
Apathy19.04.04.0020.043823%Not Available
Aphasia19.21.01.001; 17.02.03.0010.028172%
Aplastic anaemia01.03.03.0020.002450%Not Available
Arrhythmia02.03.02.0010.050084%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia08.01.02.004; 17.02.02.001--
Athetosis17.01.01.004--Not Available
Atrial fibrillation02.03.03.002--
Atrioventricular block02.03.01.0020.009391%Not Available
Atrioventricular block first degree02.03.01.004--
Back disorder15.03.01.014--Not Available
Back pain15.03.04.005--
Belligerence19.05.01.0150.012521%Not Available
Bipolar I disorder19.16.01.002--Not Available
Bladder pain20.02.02.001--Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.006260%Not Available
Blindness17.17.01.003; 06.02.02.001--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood cholesterol abnormal13.12.01.0090.006260%Not Available
Blood cholesterol increased13.12.01.0020.037563%
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