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 As an oral extended-release tablet and a once-monthly extended-release suspension for intramuscular injection, paliperidone is indicated for the treatment of adults and adolescents with schizophrenia and in the treatment of schizoaffective disorder in combination with antidepressants or mood stabilizers.[L16168,L37744] Paliperidone is also available in both an every-three-month and twice-yearly extended-release suspension for intramuscular injection for the treatment of schizophrenia.[L4137,L37749]
Marketing Status approved
ATC Code N05AX13
DrugBank ID DB01267
KEGG ID D05339
MeSH ID D000068882
PubChem ID 115237
TTD Drug ID D0B3UJ
NDC Product Code 65015-736; 42292-026; 47335-744; 50458-550; 68180-524; 53104-7718; 65267-201; 66005-0050; 65162-283; 68180-525; 10147-0953; 43975-350; 60687-459; 0378-3980; 72819-160; 0904-6936; 59651-475; 61730-0008; 16714-867; 47335-767; 60687-470; 0378-3978; 0378-3979; 65162-280; 68180-526; 10147-0951; 65691-0072; 47335-766; 50458-551; 50458-552; 50458-554; 0378-3981; 0904-6937; 10147-0954; 55111-925; 47335-765; 65162-281; 0591-3692; 0591-3693; 0591-3694; 0591-3695; 72819-159; 0904-6935; 14593-855; 27808-222; 27808-225; 42292-055; 43975-349; 43975-351; 65162-282; 68180-523; 72819-157; 72819-158; 10147-0952; 66039-872; 27808-224; 43975-352; 24196-154; 53747-039; 16714-866; 16714-868; 27808-223; 14501-0051; 65372-1144; 16714-869; 42292-027
UNII 838F01T721
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
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)
Paranoia19.05.01.0050.246276%Not Available
Parkinsonism17.01.05.0030.058188%Not Available
Personality change17.02.05.019; 19.05.01.0060.007649%
Photophobia17.17.02.006; 06.01.01.0040.013659%
Pituitary tumour16.24.01.003; 05.03.05.0020.008879%Not Available
Pleurothotonus17.01.03.0090.002049%Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonia aspiration22.07.01.015; 11.01.09.019--Not Available
Pollakiuria20.02.02.007--
Polycystic ovaries21.11.01.006; 05.05.01.0140.003005%Not Available
Polydipsia14.05.02.001; 05.03.03.0020.010381%Not Available
Polydipsia psychogenic19.24.01.004; 14.05.02.0020.001366%Not Available
Posture abnormal15.03.05.029; 17.02.05.0330.005327%Not Available
Pregnancy18.08.02.004--Not Available
Pressure of speech19.19.03.0060.005327%Not Available
Priapism24.04.12.007; 21.03.01.0050.025270%Not Available
Protrusion tongue17.02.05.037; 07.14.02.0020.005327%Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.017757%Not Available
Psychomotor retardation19.15.02.0020.002049%Not Available
Psychosexual disorder19.08.02.0010.050129%Not Available
Psychotic behaviour19.03.01.0030.004371%Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.002--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary infarction24.04.09.001; 22.06.02.0020.001366%Not Available
Rales22.12.01.011--Not Available
Rash23.03.13.001--Not Available
Rash papular23.03.13.017--Not Available
Renal failure20.01.03.005--Not Available
Respiratory distress22.02.01.012--Not Available
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