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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal weight gain14.03.02.0100.024996%Not Available
Abortion missed18.01.01.0020.001366%Not Available
Acne23.02.01.001--Not Available
Acute psychosis19.03.01.0010.008879%Not Available
Adenocarcinoma16.16.01.004--Not Available
Adenoma benign16.02.02.001--Not Available
Aggression19.05.01.0010.197786%Not Available
Agitation19.06.02.001; 17.02.05.0120.197103%
Agranulocytosis01.02.03.001--Not Available
Akathisia19.06.02.006; 17.01.02.0020.424529%
Akinesia17.01.02.0030.002732%Not Available
Alanine aminotransferase increased13.03.04.005--
Albinism23.05.02.005; 14.14.04.006; 03.08.04.006--Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.0020.427261%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.001366%Not Available
Anger19.04.02.0010.045349%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anorgasmia19.08.01.0010.009971%
Anticholinergic syndrome17.05.01.0010.003415%Not Available
Antisocial behaviour19.05.01.0100.012293%Not Available
Anxiety19.06.02.0020.187268%
Apathy19.04.04.0020.025406%Not Available
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