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)
Rhinitis22.07.03.006; 11.01.13.004--
Salivary hypersecretion07.06.01.009--Not Available
Sedation17.02.04.005--Not Available
Seizure17.12.03.001--
Sexual dysfunction19.08.05.002; 21.03.02.003--Not Available
Sinus arrhythmia02.03.03.008--Not Available
Sleep disorder19.02.04.001--Not Available
Small intestinal obstruction07.13.06.001--
Somnolence19.02.05.003; 17.02.04.006--
Swelling08.01.03.015--Not Available
Swollen tongue07.14.02.003; 23.04.01.014; 10.01.05.015--Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Tardive dyskinesia17.01.02.012--Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 01.08.01.005; 23.06.01.011--
Toothache07.09.06.001--
Torticollis17.01.03.003; 15.05.04.003--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Trismus17.01.03.004; 15.05.04.004--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Muscle tightness15.05.03.007--Not Available
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