Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Palonosetron
Drug ID BADD_D01659
Description Palonosetron (INN, trade name Aloxi) is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is the most effective of the 5-HT3 antagonists in controlling delayed CINV nausea and vomiting that appear more than 24 hours after the first dose of a course of chemotherapy and is the only drug of its class approved for this use by the U.S. Food and Drug Administration. As of 2008, it is the most recent 5-HT3 antagonist to enter clinical use.
Indications and Usage For the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, as well as prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy. Also used for the prevention of postoperative nausea and vomiting for up to 24 hours post operation.
Marketing Status approved; investigational
ATC Code A04AA05
DrugBank ID DB00377
KEGG ID D07175
MeSH ID D000077924
PubChem ID 6337614
TTD Drug ID D04FVU
NDC Product Code 68001-355; 16714-834; 63323-673; 55111-694
UNII 5D06587D6R
Synonyms Palonosetron | 2-QHBIQO | Palonosetron, (R-(R*,R*))-isomer | Palonosetron, (3R)- | Palonosetron, (R-(R*,S*))-isomer | RS 25259-198 | RS 25259 198 | RS 25259198 | RS-25259-198 | RS25259198 | 2-(1-azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one | RS 25233-198 | RS 25233 198 | RS 25233198 | RS-25233-198 | RS25233198 | RS 25259 | RS-25259 | RS25259 | RS 25259-197 | RS 25259 197 | RS 25259197 | RS-25259-197 | RS25259197 | Aloxi | Palonosetron, (S-(R*,S*))-isomer | Palonosetron Hydrochloride | RS 25233-197 | RS 25233 197 | RS 25233197 | RS-25233-197 | RS25233197
Chemical Information
Molecular Formula C19H24N2O
CAS Registry Number 135729-61-2
SMILES C1CC2CN(C(=O)C3=CC=CC(=C23)C1)C4CN5CCC4CC5
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)
Sinus arrhythmia02.03.03.008--Not Available
Sinus bradycardia02.03.03.009--
Sinus tachycardia02.03.03.010--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Supraventricular extrasystoles02.03.03.011--Not Available
Tachycardia02.03.02.007--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Vein discolouration24.03.02.004--Not Available
Ventricular extrasystoles02.03.04.007--Not Available
Vomiting07.01.07.003--
Gastrointestinal hypomotility07.02.02.005--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Infusion site pain12.07.05.002; 08.02.05.014--Not Available
Metabolic disorder14.11.01.001--Not Available
Angiopathy24.03.02.007--Not Available
Induration08.01.03.020--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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