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Ondansetron Hydrochloride Oral tablet

It is used to treat nausea and vomiting caused by chemotherapy

Generic Name: ondansetron  |  Brand Name: Zofran

Brand Names: Zofran ODT, Zofran, Zuplenz, Ondansetron Hydrochloride

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 09/15/2011] ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.

BACKGROUND: Ondansetron (Zofran) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which ondansetron may cause QT interval prolongation.

RECOMMENDATION: The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

ONDANSETRON (on DAN se tron) is used to treat nausea and vomiting caused by chemotherapy. It is also used to prevent or treat nausea and vomiting after surgery.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • history of irregular heartbeat
  • liver disease
  • low levels of magnesium or potassium in the blood
  • an unusual or allergic reaction to ondansetron, granisetron, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

-apomorphine
This medicine may also interact with the following medications:

-carbamazepine
-phenytoin
-rifampicin
-tramadol

What should I watch for while using this medicine?

Check with your doctor or health care professional right away if you have any sign of an allergic reaction.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips or tongue
  • breathing problems
  • dizziness
  • fast or irregular heartbeat
  • feeling faint or lightheaded, falls
  • fever and chills
  • swelling of the hands or feet
  • tightness in the chest

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation or diarrhea
  • headache

Where should I keep my medicine?

Keep out of the reach of children.

Store between 2 and 30 degrees C (36 and 86 degrees F). Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: September 23, 2011
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