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)
Dyspnoea02.11.05.003; 22.02.01.004--
Ear disorder04.03.01.001--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Electrocardiogram T wave amplitude decreased13.14.05.006--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.001--Not Available
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003--Not Available
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.003--Not Available
Eye swelling06.08.03.003--Not Available
Fatigue08.01.01.002--
Feeling hot08.01.09.009--Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.004--
Glycosuria20.02.01.005--
Headache17.14.01.001--
Hiccups22.12.01.001; 07.01.06.009--
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.003--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperkalaemia14.05.03.001--
Hypersensitivity10.01.03.003--
Hypersomnia19.02.05.001; 17.15.01.001--
Hypertension24.08.02.001--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
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