Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paliperidone palmitate
Drug ID BADD_D01657
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 D05340
MeSH ID D000068882
PubChem ID 9852746
TTD Drug ID D0B3UJ
NDC Product Code 58032-1010; 64552-4063; 50458-609; 14501-0069; 50458-560; 64552-4076; 65372-1174; 68108-0630; 65089-0047; 50458-562; 50458-606; 55111-926; 47848-058; 50458-607; 50458-611; 64552-4037; 64552-4066; 50458-561; 50458-563; 65085-0066; 50458-564; 50458-608; 50458-612
UNII R8P8USM8FR
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 C39H57FN4O4
CAS Registry Number 199739-10-1
SMILES CCCCCCCCCCCCCCCC(=O)OC1CCCN2C1=NC(=C(C2=O)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F)C
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---
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001---
Akathisia17.01.02.002; 19.06.02.006--
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009---
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Atrioventricular block first degree02.03.01.004--
Back pain15.03.04.005--
Bradycardia02.03.02.002---
Bradykinesia17.01.02.004---
Breast discharge21.05.05.001---
Breast engorgement21.05.05.002; 18.08.02.001---
Breast pain21.05.05.003--
Breast tenderness21.05.05.004---
Bundle branch block02.03.01.009---
Bundle branch block left02.03.01.007---
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cerebrovascular disorder24.03.05.002; 17.08.02.002---
Cogwheel rigidity17.01.05.001; 15.05.04.006---
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
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