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)
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.0050.036197%Not Available
Injection site induration08.02.03.007; 12.07.03.0070.083321%Not Available
Injection site inflammation08.02.03.008; 12.07.03.0090.009971%Not Available
Injection site irritation12.07.03.027; 08.02.03.0270.016937%Not Available
Injection site mass12.07.03.010; 08.02.03.0090.444062%Not Available
Injection site necrosis12.07.03.020; 08.02.03.0200.002049%Not Available
Injection site pain12.07.03.011; 08.02.03.0100.666981%Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.0130.023221%Not Available
Injection site rash08.02.03.032; 23.03.13.010; 12.07.03.0320.082365%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.221416%
Injection site ulcer23.07.03.012; 12.07.03.017; 08.02.03.0160.006966%Not Available
Injection site urticaria12.07.03.029; 10.01.06.003; 08.02.03.029; 23.04.02.0030.003005%Not Available
Injection site vesicles23.03.01.024; 12.07.03.051; 08.02.03.0510.006966%Not Available
Injection site warmth12.07.03.036; 08.02.03.0360.026226%Not Available
Insomnia19.02.01.002; 17.15.03.0020.154486%
Insulin C-peptide increased13.10.02.011--Not Available
Intentional self-injury19.12.01.002; 12.01.08.0360.051495%Not Available
Intestinal obstruction07.13.01.002--Not Available
Irritability19.04.02.013; 08.01.03.0110.089741%
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint stiffness15.01.02.003--Not Available
Joint swelling15.01.02.004--Not Available
Lacrimation increased06.08.02.004--
Laryngeal pain22.12.03.010--
Laryngospasm22.04.02.002--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.075536%
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.0010.032646%
Libido increased21.03.02.007; 19.08.03.0020.003005%
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
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