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)
Violence-related symptom19.05.01.0220.006010%Not Available
Consciousness fluctuating17.02.04.0190.002049%Not Available
Negative thoughts19.15.02.0120.001366%Not Available
Communication disorder19.19.01.0080.007376%Not Available
Disturbance in social behaviour19.05.01.0180.025406%Not Available
Foaming at mouth08.01.03.070; 07.05.05.019; 17.02.05.0560.001366%Not Available
Myosclerosis15.05.03.032--Not Available
Tachyphrenia17.03.03.007; 19.10.03.0100.009971%Not Available
Excessive eye blinking17.17.02.010; 06.05.01.0040.007649%Not Available
Schizoaffective disorder bipolar type19.03.02.0030.004781%Not Available
Decreased eye contact19.01.02.012; 17.02.05.0550.005327%Not Available
Disorganised speech19.19.02.005; 17.02.08.0170.004644%Not Available
Administration site induration08.02.04.022; 12.07.04.0220.001366%Not Available
Administration site pain12.07.04.029; 08.02.04.0290.001366%Not Available
Behaviour disorder19.01.01.0050.009971%Not Available
Bell's palsy17.04.03.0110.001366%Not Available
Bilateral breast buds21.05.04.0140.004644%Not Available
Disruptive mood dysregulation disorder19.21.04.0050.003005%Not Available
Eosinophilic pleural effusion01.02.04.023; 22.05.02.0090.004098%Not Available
Fear of injection19.06.03.0160.010654%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Injection site discharge12.07.03.057; 08.02.03.0570.007649%Not Available
Injection site hypoaesthesia17.02.06.051; 12.07.03.060; 08.02.03.0600.004644%Not Available
Injection site indentation23.03.03.086; 12.07.03.061; 08.02.03.0610.004644%Not Available
Injection site scab12.07.03.069; 08.02.03.069; 23.03.03.0880.004644%Not Available
Limb mass15.03.05.0190.006966%Not Available
Malignant catatonia19.11.01.0030.001366%Not Available
Physical deconditioning08.01.03.0960.002732%Not Available
Plasma cell mastitis21.05.03.0070.002049%Not Available
Post-injection delirium sedation syndrome19.13.02.004; 17.02.04.024; 12.02.05.0570.004781%Not Available
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