For additional Zofran information, visit our other Zofran pages: Zofran and birth defects, Zofran studies, Zofran Lawsuits, or What Types of Birth Defects are Associated with Zofran Use?
If you have been experiencing morning sickness and nausea during your pregnancy, your doctor may have prescribed or spoken to you about taking Zofran. Zofran can be prescribed as a tablet or in liquid form and is also available in its generic form named ondansetron. Approximately 1 million pregnant women are prescribed Zofran each year to treat morning sickness and nausea. It is an effective medication that works to block the receptors in your body that trigger the feeling of nausea.
The issue at hand is that Zofran is not an FDA approved medication for use in pregnant women experiencing morning sickness. Taking Zofran, or ondansetron, for morning sickness carries unknown risks to the health of the fetus due to the lack of safety trials conducted. During pregnancy, it is generally in the best interest of the mother to take an abundance of caution when dealing with any potential risks to the fetus.
Currently, Zofran is classified by the FDA as a “Pregnancy Category B” drug, meaning that there have been no well-controlled studies on the effects of the drug on pregnant women. There is, however, an FDA “Pregnancy Category A” drug called Diclegis, which has been recently approved to treat nausea and morning sickness in pregnant women. “Pregnancy Category A” medications have been tested and confirmed to not carry any serious relative risks to the fetus or mother during pregnancy.
Currently, the FDA has only definitively stated that the use of Zofran is possibly linked to Serotonin Syndrome. Serotonin Syndrome is a condition that occurs from an increased CNS serotonergic activity and causes excessive nerve cell activity in the brain. Some symptoms of serotonin syndrome are extreme anxiety and feeling over energized. Other possible side effects have been recorded, such as cleft palates in newborns, but require further research to conclusively link to Zofran.
Because the risks of Zofran are still generally unknown, it is in a mother’s best interest to consult with a doctor about any concerns prior to taking the medication. Furthermore, if you have been experiencing dizziness, shortness of breath, extreme fatigue, or an irregular heartbeat after having taken Zofran, seek emergency medical attention and contact your primary care physician.
If you have any concerns or questions, always be sure to consult with your physician, OBGYN, or child’s pediatrician.