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 For the treatment of schizophrenia.
Marketing Status Prescription; Discontinued
ATC Code N05AX13
DrugBank ID DB01267
KEGG ID D05339
MeSH ID D000068882
PubChem ID 115237
TTD Drug ID D0B3UJ
NDC Product Code 16714-867; 0591-3694; 42292-026; 16714-866; 27808-223; 14593-855; 65691-0072; 0378-3979; 61730-0008; 10147-0951; 16714-869; 62756-502; 0591-3692; 27808-224; 65162-282; 50458-550; 59651-475; 65162-281; 42292-027; 10147-0954; 0904-6936; 43975-352; 55111-925; 50458-552; 47335-765; 53747-039; 0904-6937; 27808-225; 16714-868; 43975-349; 24196-154; 66039-872; 65372-1144; 65015-736; 10147-0953; 60687-470; 43975-350; 10147-0952; 47335-744; 14501-0051; 65267-201; 65162-280; 50458-551; 27808-222; 0378-3980; 0378-3981; 60687-459; 47335-767; 43975-351; 53104-7718; 0591-3693; 50458-554; 42292-055; 65162-283; 0904-6935; 47335-766; 0378-3978; 0591-3695
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
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)
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.006--Not Available
Chronic kidney disease20.01.03.017--
Waist circumference increased13.15.01.033--Not Available
Head titubation17.01.06.006--Not Available
Substance abuse19.07.02.0060.078256%Not Available
Hypersexuality19.08.03.0050.009391%Not Available
Floppy iris syndrome17.02.11.001; 12.02.02.001; 06.05.03.007--Not Available
Treatment failure08.06.01.017--Not Available
Psychiatric decompensation19.01.02.0100.018781%Not Available
Skin mass23.07.04.0140.025042%Not Available
Oromandibular dystonia17.01.03.0060.006260%Not Available
Brain injury19.07.03.007; 17.11.01.003--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Anosognosia19.21.01.004; 17.02.03.0100.006260%Not Available
Creatinine renal clearance abnormal13.13.01.0160.006260%Not Available
Acute kidney injury20.01.03.016--
Slow speech19.19.02.004; 17.02.08.0160.012521%Not Available
Resting tremor17.01.06.0080.006260%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Muscle tone disorder15.05.04.017; 17.05.02.0140.006260%Not Available
Medication residue present13.15.01.0320.037563%Not Available
Language disorder19.19.01.006; 17.02.08.0150.006260%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Anal incontinence17.05.01.021; 07.01.06.0290.015651%
Liver function test increased13.03.01.044--Not Available
Somatic symptom disorder19.24.01.0060.006260%Not Available
Attention-seeking behaviour19.05.01.0160.009391%Not Available
Hypermetabolism14.11.01.0180.006260%Not Available
Impulsive behaviour19.18.01.0010.012521%Not Available
Jealous delusion19.10.01.0060.006260%Not Available
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