Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Palonosetron hydrochloride
Drug ID BADD_D01660
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 D05343
MeSH ID D000077924
PubChem ID 6918303
TTD Drug ID D04FVU
NDC Product Code 0781-3415; 11014-0199; 60862-003; 14593-846; 54893-0013; 65862-736; 0703-4094; 67184-0514; 67184-0515; 14501-0070; 63827-1011; 67262-0001; 36000-326; 0143-9513; 67457-317; 0409-2504; 70860-785; 55111-914; 58175-0543; 62147-0218; 69097-927; 0781-3312; 25021-783; 68001-482; 60505-6193; 69543-371; 53104-7733; 58032-0135; 67184-0013; 55150-186; 47848-027
UNII 23310D4I19
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 C19H25ClN2O
CAS Registry Number 135729-62-3
SMILES C1CC2CN(C(=O)C3=CC=CC(=C23)C1)C4CN5CCC4CC5.Cl
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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Amblyopia06.02.01.001---
Anxiety19.06.02.002--
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Blood bilirubin increased13.03.04.018--
Blood pressure decreased13.14.03.002---
Bradycardia02.03.02.002---
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Dermatitis allergic23.03.04.003; 10.01.03.014---
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Electrocardiogram QT prolonged13.14.05.004--
Electrocardiogram T wave amplitude decreased13.14.05.006---
Electrolyte imbalance14.05.01.002---
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003---
Eye irritation06.04.05.003---
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Generalised oedema14.05.06.007; 08.01.07.004--
Glycosuria20.02.01.005--
Headache17.14.01.001--
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