Ondansetron Hydrochloride Solution Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2.
- Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
- Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Ondansetron Oral Solution, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
There is currently no drug history available for this drug.
The active ingredient in Ondansetron Oral Solution, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:
The molecular formula is C18H19N3O∙HCl∙2H2O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline.
Each 5 mL of Ondansetron Oral Solution, USP contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Ondansetron Oral Solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, saccharin sodium, sodium benzoate, sodium citrate, and strawberry flavor.