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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alopecia23.02.02.001--
Amblyopia06.02.01.001--Not Available
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Atrioventricular block first degree02.03.01.004--
Atrioventricular block second degree02.03.01.005--
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cyanosis02.11.04.004; 24.03.01.007; 22.02.02.007; 23.06.04.005--
Dermatitis23.03.04.002--Not Available
Dermatitis atopic23.03.04.016; 10.01.04.004--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dizziness postural02.11.04.008; 24.06.02.008; 17.02.05.004--Not Available
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
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