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Zofran 8mg Tablet
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Indications & Clinical Uses
- Zofran brand products are reported by Drugs.com as discontinued in the US (a marketing decision, not a reported safety withdrawal), and generic ondansetron remains available; this status was not confirmed on an FDA page.
- Zofran 8 mg tablets (yellow; a 4 mg tablet also exists) contain ondansetron, a 5-HT3 receptor antagonist that prevents nausea and vomiting.
- The US label covers prevention of nausea and vomiting from highly emetogenic chemotherapy (including cisplatin at 50 mg/m2 or more), moderately emetogenic chemotherapy, radiotherapy (total body, or abdominal single or daily fractions) and postoperative nausea and vomiting.
- In children, use is established from age 4 and for moderately emetogenic chemotherapy only.
- The US label holder is Novartis Pharmaceuticals Corporation.
- Zofran prevents nausea; it is not a treatment for stomach infections.
Side Effects
- In chemotherapy trials the most common reactions were headache (24%), malaise or fatigue (13%) and constipation (9%).
- After radiotherapy, headache, constipation and diarrhea were most common, and in postoperative studies headache (9%) and low oxygen levels (hypoxia, 9%).
- Serious reactions include anaphylaxis and bronchospasm (allergic reactions), QT prolongation with torsades de pointes (an irregular heart rhythm causing palpitations or fainting), serotonin syndrome (agitation, sweating, fever, tremor, fast heartbeat) and masking of a bowel blockage (ileus) after surgery.
- The US label has no boxed warning.
- Seek urgent help for swelling of the face or throat, difficulty breathing, fainting or a racing or irregular heartbeat.
Precautions & Warnings
- Zofran is contraindicated in anyone with hypersensitivity to ondansetron or its ingredients and in patients using apomorphine, because of profound low blood pressure and loss of consciousness.
- Avoid Zofran in congenital long QT syndrome, and take extra care if you have heart rhythm problems.
- Bowel activity is watched after abdominal surgery because Zofran can mask ileus.
- Pregnancy data are inconsistent and animal studies showed no fetal harm; it is unknown whether ondansetron passes into human breast milk.
- Doses depend on the use, for example a single 24 mg dose 30 minutes before highly emetogenic chemotherapy and 16 mg one hour before anaesthesia for postoperative nausea, so follow your prescriber's instructions.
- Store tablets at 2 C to 30 C in a tight, light-resistant container away from light.
Avoid Interactions
- Medicines that increase risk: apomorphine is contraindicated with Zofran.
- Serotonergic medicines, including SSRIs, SNRIs, MAOIs and tramadol, can cause serotonin syndrome when combined with ondansetron, and monitoring is advised.
- Medicines and conditions that affect the heart rhythm add to the QT risk, so tell your prescriber about them.
- Tramadol may also need higher doses for pain relief when used with ondansetron.
- Medicines that reduce effect: CYP3A4 inducers speed up the clearance of ondansetron and may lower its levels.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and herbal supplements before you start Zofran.
References
Frequently Asked Questions
Zofran 8 mg (ondansetron) tablets prevent nausea and vomiting caused by chemotherapy, radiotherapy and surgery. Zofran is a 5-HT3 blocker. In children, use is established from age 4 and for moderately emetogenic chemotherapy only. It prevents nausea rather than treating other causes.
Take Zofran (ondansetron) tablets by mouth exactly as prescribed, usually starting 30 minutes before chemotherapy. For moderately emetogenic chemotherapy the label dose is 8 mg, then 8 mg 8 hours later, then twice daily for 1 to 2 days. Highly emetogenic chemotherapy uses a single 24 mg dose.
Common Zofran side effects include headache, tiredness and constipation, and some people get diarrhea. Serious effects are allergic reactions, an irregular heartbeat (QT prolongation) and serotonin syndrome. Get urgent help for face or throat swelling, breathing trouble, fainting or a racing heartbeat. There is no boxed warning.
Never take Zofran (ondansetron) with apomorphine, which can cause a dangerous drop in blood pressure and fainting. Use caution with serotonergic medicines such as SSRIs, SNRIs, MAOIs and tramadol, and avoid Zofran if you have congenital long QT syndrome. Tell your prescriber about heart-rhythm medicines.
Zofran tablets are established for children aged 4 and over, and only to prevent nausea from moderately emetogenic chemotherapy. Zofran (ondansetron) has not been established for children in other uses on the US label. A healthcare provider sets the dose.
Drugs.com reports the Zofran brand as discontinued in the US, while generic ondansetron remains available. This is a marketing status, not a reported safety withdrawal, and it was not confirmed on an FDA page. Ask your pharmacist about equivalent ondansetron tablets.
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