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 For the treatment of schizophrenia.
Marketing Status Prescription; Discontinued
ATC Code N05AX13
DrugBank ID DB01267
KEGG ID D05340
MeSH ID D000068882
PubChem ID 9852746
TTD Drug ID D0B3UJ
NDC Product Code 50458-561; 58032-1010; 65089-0047; 50458-606; 65085-0066; 64552-4063; 47848-058; 50458-560; 55111-926; 65372-1174; 50458-564; 64552-4066; 64552-4076; 68108-0630; 14501-0069; 50458-609; 50458-612; 50458-563; 50458-611; 50458-562; 50458-608; 50458-607
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Menstrual disorder21.01.01.004--Not Available
Menstruation delayed21.01.02.003; 05.05.01.010--Not Available
Menstruation irregular21.01.01.005; 05.05.01.008--
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neuroleptic malignant syndrome12.03.01.003; 08.05.01.005; 17.05.02.003; 15.05.04.015--Not Available
Neutropenia01.02.03.004--Not Available
Nightmare19.02.03.003--Not Available
Oculogyric crisis17.01.03.002; 06.05.02.002--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Parkinsonism17.01.05.003--Not Available
Pneumonia aspiration22.01.01.005--Not Available
Priapism21.03.01.005--Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.011--Not Available
Rash23.03.13.001--Not Available
Rash papular23.03.13.017--Not Available
Restlessness17.02.05.021; 19.11.02.002--
Retrograde ejaculation21.03.01.006--Not Available
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