Zofran (Ondansetron) - Summary

ZOFRAN SUMMARY

The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type.

ZOFRAN (ONDANSETRON) is indicated for the following:

     1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin50 mg/m2.
     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, ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.

See all Zofran indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zofran (Ondansetron)

Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. [2014]
hyperemesis gravidarum... CONCLUSION: Ondansetron and metoclopramide demonstrated similar antiemetic and

Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. [2014]
pyridoxine was superior for the treatment of nausea and vomiting of pregnancy... CONCLUSION: Our investigation showed ondansetron to be superior to the

Ondansetron reducing pain on injection of etomidate: a controlled randomized study. [2014]
of etomidate... CONCLUSION: This study illustrates that pre-treatment with intravenous

Effect of oral ondansetron on decreasing the vomiting associated with acute gastroenteritis in Iranian children. [2013]
in decreasing the vomiting due to acute gastroenteritis in children... CONCLUSION: Although administrayion of oral ondansetron in gastroenteritis could

Ondansetrone or metoclopromide? Which is more effective in severe nausea and vomiting of pregnancy? A randomized trial double-blind study. [2013]
of OND versus metoclopramide (MET) in the treatment of HG... CONCLUSION: OND has a more favorable effect in controlling severe vomiting.

more studies >>

Clinical Trials Related to Zofran (Ondansetron)

To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects [Completed]
Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will be used as a positive control and will be given orally. The cardiac repolarization will be measured by taking consecutive ECGs on a recording device known as a Holter monitor and measuring the QT interval at specified times. In addition, blood samples will also be taken at specified times and will be used to measure the amount of study medication in the body.

Ondansetron and the QT Interval In Adult Emergency Department Patients [Completed]
The purpose of this study is to assess the use of the medication ondansetron (zofran) in the emergency department. There are studies of the ability of ondansetron to cause a prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but not on emergency department patients. This is an observational study where patients that are going to receive the anti-nausea medicine ondansetron in the emergency department will have an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and returns to normal in that time period. Any serious outcomes will be reported. There is expected to be no adverse outcomes from this routinely used medication.

How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women [Completed]
This is called "Aim 1" of the investigators' NIH grant. Ondansetron (Zofran) is a safe and effective drug used in pregnant women to prevent nausea but the investigators do not know what effect pregnancy may have on the metabolism of Zofran in pregnant women or their babies. Therefore the investigators will enroll approximately 40 pregnant women and their babies and draw blood samples from the mother, the baby and the cord, to determine how much Zofran is in each sample of blood (called the pharmacokinetics or PK of Zofran). The pregnant women will receive Zofran, as a standard-of-care drug, for their scheduled Cesarean Section. The investigators will also enroll about 20 non-pregnant women undergoing surgery who will receive Zofran as standard-of-care during surgery. In both the pregnant & the non-pregnant women, the investigators will draw blood samples at the same time points based on number of minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the investigators move into Aim 2 of the study, which will be done in pregnant, narcotic-addicted mothers and their babies who are born addicted to narcotics. Aim 2 will be listed separately as it will be an interventional study.

Cross-over Bioequivalence Fasting Study to Compare Ondansetron Oral Soluble Film (OSF)With Zofran Orally Disintegrating Tablets(ODT) [Completed]
The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF 8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg) (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female adult, human study participants under fasting conditions. • To monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fasting conditions.

Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions [Completed]

more trials >>

Reports of Suspected Zofran (Ondansetron) Side Effects

Vomiting (37),  Nausea (31),  Malaise (29),  Abdominal Pain (27),  Headache (26),  Fatigue (22),  Pruritus (17),  Maternal Exposure During Pregnancy (17),  Cognitive Disorder (17),  Drug Ineffective (15), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Zofran review by 21 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		nausea
Dosage & duration:		4mg taken once daily for the period of 6 months
Other conditions:		pregnancy
Other drugs taken:		prenatal vitamins
		Reported Results
Benefits:		cured the hyperemesis I was suffering completely with no noticeable side effects.
Side effects:		Because it specifically treats the stomach there were no side effects to any other part of my body.
Comments:		I was suffering hyperemesis during pregnancy and was not able to take other anti nausea pills due to side effects and potential risks to the fetus. So this very safe, gentle pill was given to me and it worked perfectly.

Zofran review by 34 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		nausea
Dosage & duration:		4mg taken 2 times/day for the period of 4 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		no nausea, less vomiting. able to get through work and school feeling better
Side effects:		mild dizziness, sometimes I would get a headache
Comments:		I was prescribes 4 mg zofran to take 4 times per day for relief of nausea and vomiting which was most likely due to vertigo. I had a decrease in the nausea symptoms after the first dose, and had total relief after about 3 doses. i did experience a mile headache, which I believe is common for this drug

Zofran review by 46 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		nausea (after surgery)
Dosage & duration:		2mg IV push taken 1x for the period of 1 hour
Other conditions:		none
Other drugs taken:		Dilaudid
		Reported Results
Benefits:		Was prescribed in hospital to relieve nausea I was suffering, post foraminotomy.
Side effects:		Anaphylactic reaction. Extreme shaking of extremities. Loss of consciousness. Treated by hospital ER staff. Prior known allergic reaction to Compazine, hospital pharmacy said they were unrelated class of drugs and should not have caused allergic reaction. Physician suggested I take no anti-nausea drugs from now on.
Comments:		IV Steroids.