Ondansetron

Ondansetron

Ondansetron 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 hydrochloride 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2. 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. 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. 4. 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 tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.

History

There is currently no drug history available for this drug.

Other Information

The active ingredient in ondansetron tablets 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:

chemical structure

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 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only).

This product meets USP Dissolution Test 3.

Ondansetron Manufacturers


  • Proficient Rx Lp
    Ondansetron (Ondansetron Hydrochloride) Tablet, Film Coated [Proficient Rx Lp]
  • Proficient Rx Lp
    Ondansetron Tablet, Orally Disintegrating [Proficient Rx Lp]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ondansetron Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Northwind Pharmaceuticals, Llc
    Ondansetron (Ondansetron Hydrochloride) Tablet, Film Coated [Northwind Pharmaceuticals, Llc]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Cardinal Health
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Cardinal Health]
  • Bluepoint Laboratories
    Ondansetron Tablet, Orally Disintegrating [Bluepoint Laboratories]
  • West-ward Pharmaceutical Corp.
    Ondansetron (Ondansetron Hydrochloride) Injection [West-ward Pharmaceutical Corp.]
  • Stat Rx Usa
    Ondansetron Tablet, Orally Disintegrating [Stat Rx Usa]
  • Sun Pharmaceutical Industries Limited
    Ondansetron Tablet, Orally Disintegrating [Sun Pharmaceutical Industries Limited]
  • Major Pharmaceuticals
    Ondansetron (Ondansetron Hydrochloride) Tablet [Major Pharmaceuticals]
  • Pd-rx Pharmaceuticals, Inc.
    Ondansetron (Ondansetron) Tablet, Orally Disintegrating [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ondansetron Tablet, Orally Disintegrating [Lake Erie Medical Dba Quality Care Products Llc]
  • Baxter Healthcare Corporation
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Baxter Healthcare Corporation]
  • Physicians Total Care, Inc.
    Ondansetron Tablet, Orally Disintegrating [Physicians Total Care, Inc.]
  • Ranbaxy Pharmaceuticals Inc.
    Ondansetron Tablet, Film Coated Ondansetron Tablet, Film Coated [Ranbaxy Pharmaceuticals Inc.]
  • Cardinal Health
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Cardinal Health]
  • Actavis Inc.
    Ondansetron Tablet, Film Coated [Actavis Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ondansetron Tablet, Orally Disintegrating [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Ondansetron (Ondansetron Hydrochloride) Injection [Physicians Total Care, Inc.]
  • West-ward Pharmaceutical Corp
    Ondansetron (Ondansetron Hydrochloride) Tablet Ondansetron Tablet [West-ward Pharmaceutical Corp]
  • Dispensing Solutions, Inc.
    Ondansetron Tablet, Orally Disintegrating [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Ondansetron (Ondansetron) Tablet, Orally Disintegrating [Dispensing Solutions, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ondansetron (Ondansetron) Tablet, Orally Disintegrating [Pd-rx Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc
    Ondansetron Tablet, Orally Disintegrating [Preferred Pharmaceuticals, Inc]
  • Stat Rx Usa Llc
    Ondansetron Tablet, Film Coated [Stat Rx Usa Llc]
  • Life Line Home Care Services, Inc.
    Ondansetron Tablet, Film Coated [Life Line Home Care Services, Inc.]
  • Hhs/program Support Center/supply Service Center
    Ondansetron Tablet, Orally Disintegrating [Hhs/program Support Center/supply Service Center]
  • Rebel Distributors Corp
    Ondansetron Tablet, Orally Disintegrating [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Ondansetron Tablet, Orally Disintegrating [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Ondansetron Tablet, Orally Disintegrating [Rebel Distributors Corp]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Ondansetron Tablet, Orally Disintegrating [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Preferred Pharmaceuticals, Inc.
    Ondansetron Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ondansetron Tablet, Orally Disintegrating [Lake Erie Medical Dba Quality Care Products Llc]
  • Mylan Institutional Inc.
    Ondansetron Tablet, Film Coated [Mylan Institutional Inc.]
  • Unit Dose Services
    Ondansetron Tablet, Orally Disintegrating [Unit Dose Services]
  • The Medicines Company
    Ondansetron (Ondansetron Hydrochloride) Injection [The Medicines Company]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Pfizer Laboratories Div Pfizer Inc
    Ondansetron (Ondansetron) Injection [Pfizer Laboratories Div Pfizer Inc ]
  • Pfizer Laboratories Div Pfizer Inc
    Ondansetron Injection [Pfizer Laboratories Div Pfizer Inc ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc.
    Ondansetron Tablet, Orally Disintegrating [Preferred Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ondansetron Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Bd Rx Inc.
    Ondansetron (Ondansetron Hydrochloride
) Injection, Solution [Bd Rx Inc.
]
  • Preferred Pharmaceuticals, Inc.
    Ondansetron Tablet, Orally Disintegrating [Preferred Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Hospira, Inc.
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Hospira, Inc.]
  • Cardinal Health
    Ondansetron Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Ondansetron Injection, Solution [Remedyrepack Inc. ]
  • Cardinal Health
    Ondansetron Tablet, Orally Disintegrating [Cardinal Health]
  • Cardinal Health
    Ondansetron Tablet, Orally Disintegrating [Cardinal Health]
  • Cardinal Health
    Ondansetron Tablet, Film Coated [Cardinal Health]
  • Clinical Solutions Wholesale
    Ondansetron Tablet, Orally Disintegrating [Clinical Solutions Wholesale]
  • Remedyrepack Inc.
    Ondansetron Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ondansetron Injection, Solution [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Ondansetron Tablet, Orally Disintegrating [Clinical Solutions Wholesale]
  • Remedyrepack Inc.
    Ondansetron Injection, Solution [Remedyrepack Inc. ]
  • Rnabaxy Pharmaceuticals Inc.
    Ondansetron (Ondansetron) Tablet, Orally Disintegrating [Rnabaxy Pharmaceuticals Inc.]
  • Aidarex Pharmaceuticals Llc
    Ondansetron Tablet, Orally Disintegrating [Aidarex Pharmaceuticals Llc]
  • Remedyrepack Inc.
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Remedyrepack Inc. ]
  • Glenmark Generics Inc., Usa
    Ondansetron Tablet, Film Coated Ondansetron Tablet, Orally Disintegrating [Glenmark Generics Inc., Usa]
  • Teva Parenteral Medicines, Inc.
    Ondansetron Injection, Solution [Teva Parenteral Medicines, Inc.]
  • Teva Parenteral Medicines, Inc.
    Ondansetron Injection, Solution [Teva Parenteral Medicines, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ondansetron Tablet, Orally Disintegrating [Pd-rx Pharmaceuticals, Inc.]
  • Sandoz Inc
    Ondansetron Tablet, Film Coated [Sandoz Inc]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Direct Rx
    Ondansetron Tablet, Orally Disintegrating [Direct Rx]
  • Direct Rx
    Ondansetron Tablet, Film Coated [Direct Rx]
  • West-ward Pharmaceutical Corp.
    Ondansetron Injection [West-ward Pharmaceutical Corp.]
  • West-ward Pharmaceutical Corp.
    Ondansetron Injection [West-ward Pharmaceutical Corp.]
  • Proficient Rx
    Ondansetron Tablet, Orally Disintegrating [Proficient Rx]
  • Northstar Rx Llc
    Ondansetron (Ondansetron Hydrochloride) Solution [Northstar Rx Llc]
  • St Marys Medical Park Pharmacy
    Ondansetron Tablet, Orally Disintegrating [St Marys Medical Park Pharmacy]
  • Sandoz Inc
    Ondansetron Tablet, Orally Disintegrating [Sandoz Inc]
  • Sandoz Inc
    Ondansetron Tablet, Film Coated [Sandoz Inc]
  • Proficient Rx Lp
    Ondansetron Tablet, Film Coated [Proficient Rx Lp]
  • Auromedics Pharma Llc
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Auromedics Pharma Llc]
  • Bryant Ranch Prepack
    Ondansetron Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Ondansetron Tablet, Film Coated [Bryant Ranch Prepack]
  • West-ward Pharmaceutical Corp
    Ondansetron Injection [West-ward Pharmaceutical Corp]
  • Clinical Solutions Wholesale
    Ondansetron Tablet, Film Coated [Clinical Solutions Wholesale]
  • Cardinal Health
    Ondansetron Tablet, Orally Disintegrating [Cardinal Health]
  • Cardinal Health
    Ondansetron Injection [Cardinal Health]
  • Fresenius Kabi Usa, Llc
    Ondansetron (Ondansetron Hydrochloride) Injection [Fresenius Kabi Usa, Llc]
  • Cardinal Health
    Ondansetron Tablet, Orally Disintegrating [Cardinal Health]
  • Cardinal Health
    Ondansetron Injection [Cardinal Health]
  • Apotex Corp
    Ondansetron (Ondansetron Hydrochloride) Solution [Apotex Corp]
  • Bryant Ranch Prepack
    Ondansetron Tablet, Orally Disintegrating [Bryant Ranch Prepack]
  • Silarx Pharmaceuticals, Inc
    Ondansetron (Ondansetron Hydrochloride) Solution [Silarx Pharmaceuticals, Inc]
  • Citron Pharma Llc
    Ondansetron Tablet, Orally Disintegrating [Citron Pharma Llc]
  • Auromedics Pharma Llc
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Auromedics Pharma Llc]
  • Sandoz Inc
    Ondansetron Injection, Solution [Sandoz Inc]
  • Cardinal Health
    Ondansetron Tablet, Film Coated [Cardinal Health]
  • Aurobindo Pharma Limited
    Ondansetron (Ondansetron Hydrochloride) Solution [Aurobindo Pharma Limited]
  • Direct Rx
    Ondansetron Tablet, Orally Disintegrating [Direct Rx]
  • Taro Pharmaceuticals U.s.a., Inc.
    Ondansetron (Ondansetron Hydrochloride) Solution [Taro Pharmaceuticals U.s.a., Inc.]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Aurobindo Pharma Limited
    Ondansetron Tablet, Orally Disintegrating [Aurobindo Pharma Limited]
  • Mylan Pharmaceuticals Inc.
    Ondansetron Tablet, Orally Disintegrating [Mylan Pharmaceuticals Inc.]
  • Mylan Pharmaceuticals Inc.
    Ondansetron Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Qilu Pharmaceutical Co., Ltd.
    Ondansetron Injection, Solution [Qilu Pharmaceutical Co., Ltd.]
  • Proficient Rx Lp
    Ondansetron Tablet, Orally Disintegrating [Proficient Rx Lp]
  • Remedyrepack Inc.
    Ondansetron Tablet, Orally Disintegrating [Remedyrepack Inc. ]
  • Medsource Pharmaceuticals
    Ondansetron Tablet, Orally Disintegrating [Medsource Pharmaceuticals]
  • Medsource Pharmaceuticals
    Ondansetron Tablet, Orally Disintegrating [Medsource Pharmaceuticals]
  • Preferred Pharmaceuticals Inc.
    Ondansetron Tablet, Orally Disintegrating [Preferred Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Ondansetron (Ondansetron Hydrochloride) Injection, Solution [Remedyrepack Inc. ]

Login To Your Free Account