MedPath

Ondansetron

Generic Name
Ondansetron
Brand Names
Zofran, Zuplenz
Drug Type
Small Molecule
Chemical Formula
C18H19N3O
CAS Number
99614-02-5
Unique Ingredient Identifier
4AF302ESOS

Overview

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis. The FDA withdrew its approval for the use of all intravenous drug products containing more than 16 mg of ondansetron hydrochloride in a single dose, due to a high risk of QT prolongation.

Background

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis. The FDA withdrew its approval for the use of all intravenous drug products containing more than 16 mg of ondansetron hydrochloride in a single dose, due to a high risk of QT prolongation.

Indication

In the adult patient population: i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and - the prevention and treatment of postoperative nausea and vomiting ii) intravenously administered ondansetron injection formulations are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and - the prevention and treatment of postoperative nausea and vomiting In the pediatric (4-18 years of age) patient population: i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting, ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger, iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting In the geriatric (>65 years of age) patient population: i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population

Associated Conditions

  • Chemotherapy-Induced Nausea and Vomiting
  • Cholestatic pruritus
  • Post Operative Nausea and Vomiting (PONV)
  • Radiation-Induced Nausea and Vomiting
  • Uremic Pruritus
  • Severe Hyperemesis gravidarum

Clinical Trials

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FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Redpharm Drug, Inc.
67296-1137
ORAL
4 mg in 1 1
2/7/2023
RPK Pharmaceuticals, Inc.
53002-0591
ORAL
8 mg in 1 1
11/30/2021
Hikma Pharmaceuticals USA Inc.
0641-6080
INTRAMUSCULAR, INTRAVENOUS
2 mg in 1 mL
4/1/2022
St. Mary's Medical Park Pharmacy
60760-636
ORAL
4 mg in 1 1
12/8/2023
BluePoint Laboratories
68001-246
ORAL
4 mg in 1 1
2/10/2022
Clinical Solutions Wholesale, LLC
58118-7500
ORAL
4 mg in 1 1
9/3/2020
Proficient Rx LP
63187-199
ORAL
8 mg in 1 1
3/1/2024
Fosun Pharma USA Inc.
72266-123
INTRAMUSCULAR, INTRAVENOUS
2 mg in 1 mL
1/31/2023
Northwind Pharmaceuticals, LLC
51655-933
ORAL
4 mg in 1 1
5/16/2023
Advanced Rx Pharmacy of Tennessee, LLC
80425-0073
ORAL
4 mg in 1 1
1/19/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Ondansetron Hydrochloride Injection
国药准字H20066474
化学药品
注射剂
7/30/2021
Ondansetron Hydrochloride Injection
国药准字H20056409
化学药品
注射剂
6/15/2020
Ondansetron Hydrochloride Injection
国药准字H20055086
化学药品
注射剂
9/30/2020
Ondansetron Hydrochloride Injection
国药准字H19980115
化学药品
注射剂
12/23/2020
Ondansetron Hydrochloride Injection
国药准字H20243751
化学药品
注射剂
5/21/2024
Ondansetron Hydrochloride Injection
国药准字H19980012
化学药品
注射剂
8/13/2020
Ondansetron Hydrochloride Injection
国药准字H20055769
化学药品
注射剂
3/25/2020
Ondansetron Hydrochloride Injection
国药准字H20046058
化学药品
注射剂(注射液)
1/6/2021
Ondansetron Hydrochloride Injection
国药准字H20046059
化学药品
注射剂(注射液)
1/6/2021
Ondansetron Hydrochloride Injection
国药准字H20067400
化学药品
注射剂
9/9/2021

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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