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)
Floppy iris syndrome17.02.11.001; 12.02.02.001; 06.05.03.007--Not Available
Psychiatric decompensation19.01.02.0100.006420%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.001366%Not Available
Skin mass23.07.04.0140.021582%Not Available
Oromandibular dystonia17.01.03.0060.003688%Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.001366%Not Available
Anosognosia19.21.01.004; 17.02.03.0100.002049%Not Available
Injury associated with device08.07.01.012; 12.01.08.0350.034285%Not Available
Slow speech19.19.02.004; 17.02.08.0160.005737%Not Available
Resting tremor17.01.06.0080.001366%Not Available
Substance-induced psychotic disorder19.03.01.007; 12.03.01.0530.001366%Not Available
Muscle tone disorder17.05.02.014; 15.05.04.0170.001366%Not Available
Language disorder19.19.01.006; 17.02.08.0150.001366%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.010381%
Somatic symptom disorder19.24.01.0060.001366%Not Available
Abnormal loss of weight14.03.02.0190.003688%Not Available
Attention-seeking behaviour19.05.01.0160.008332%Not Available
Delusion of grandeur19.10.01.0040.004371%Not Available
Grandiosity19.05.01.0190.003688%Not Available
Hallucination, olfactory19.10.04.0050.003005%Not Available
Head banging19.11.03.0070.001366%Not Available
Hypermetabolism14.11.01.0180.006966%Not Available
Impulsive behaviour19.18.01.0010.010654%Not Available
Jealous delusion19.10.01.0060.001366%Not Available
Overweight14.03.02.0210.009698%Not Available
Persecutory delusion19.10.01.0070.003415%Not Available
Prolactin-producing pituitary tumour16.24.07.001; 05.03.05.0050.006147%Not Available
Slow response to stimuli17.02.05.0630.005327%Not Available
Soliloquy19.05.01.0210.014342%Not Available
Somatic delusion19.10.01.0080.001366%Not Available
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