Palonosetron
Serotonin (5ht3) Antagonists
Sold as Aloxi · posfrea · AKYNZEO
- Drug class
- Serotonin (5ht3) Antagonists
- Availability
- Prescription only
- Routes
- Intravenous, Oral
- Markets covered
- 4
- Products on record
- 18
- FDA reports (12 mo)
- 525
Overview
Palonosetron is an active pharmaceutical ingredient in the Serotonin (5ht3) Antagonists group (A04AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 9 | May 1, 2026 |
| US United States | FDA | 5 | April 29, 2025 |
| EU European Union | EMA | 2 | February 20, 2026 |
| CA Canada | Health Canada | 2 | March 22, 2025 |
GBUnited Kingdom· MHRA
9 products
Uses
Palonosetron Fresenius Kabi is indicated in adults for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
How to take
USUnited States· FDA
5 products
Uses
1 INDICATIONS AND USAGE Palonosetron hydrochloride injection is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
EUEuropean Union· EMA
2 products
Uses
Palonosetron Accord is indicated in adults for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Palonosetron Accord is indicated in paediatric patients 1 month of age and older for. • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
How to take
CACanada· Health Canada
2 products
Uses
1 Pediatrics Pediatrics (2 to 17 years of age): The safety and efficacy of ALOXI injection has been established in pediatric patients aged 2 to 17 years undergoing moderately and highly emetogenic cancer chemotherapy. Data in patients aged 2 months to 2 years were limited.
No data are available in children aged less than 2 months (see ADVERSE REACTIONS/Clinical Trial Adverse Reactions [Pediatrics]; CLINICAL TRIALS). Safety and effectiveness of ALOXI capsules in patients below the age of 18 years have not been established.
2 Geriatrics No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients (18 to 64 years).
How to take
Drug interactions
Known interactions involving Palonosetron. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 385. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL088280264 · revised December 5, 2025
- [2]FDA DailyMed · 0063b66a-a71b-47… · revised May 15, 2024 [PDF]
- [3]European Medicines Agency · EMEA/H/C/004129 · revised February 20, 2026
- [4]Health Canada (DPD) · 02381710 · revised March 22, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.