Zofran (ondansetron) is a prescription drug manufactured by GlaxoSmithKline. The drug was approved by the U.S. Food and Drug Administration (FDA) for treatment of nausea and vomiting in patients undergoing cancer treatment or certain surgeries. Many doctors also prescribed Zofran for a variety of off-label conditions. Some prescribed the drug for morning sickness in pregnant women.

Birth Injury Risks

The FDA has revealed infants born to mothers who took Zofran while pregnant, in order to treat morning sickness, may be at risk of severe birth defects. The FDA Adverse Event Reporting System—a database of side effects—indicates Zofran may lead to certain birth defects, including:

  • Cleft Lip
  • Cleft Palate
  • Heart Defects
  • Kidney Problems

Developing fetuses are most vulnerable during the first trimester of pregnancy. This is also when reports of morning sickness are most common among expectant mothers. As a result, the first trimester is when a pregnant woman is most likely to be prescribed drugs like Zofran.

In 2012, GlaxoSmithKline paid a $3 billion settlement after the U.S. Department of Justice (DOJ) determined the company had promoted Zofran for off-label uses. If you took Zofran for morning sickness and your child was born with birth defects, you may be entitled to compensation.


If you have suffered harm after taking Zofran, trust Carter Mario Law Firm to help. Contact our team today at 203-876-2711 to schedule your free, no-obligation consultation.


We Can Help

Over the past three decades, our team of Connecticut personal injury attorneys has successfully handled thousands of cases. Our team-based approach allows us to pool our strengths and promote open communication. As a result, we have been able to recover millions of dollars in compensation for our clients. Regardless of the complexities of your case, we can help protect your rights.

When you or someone you love suffers serious harm caused by a dangerous drug, you need experience on your side. Let Carter Mario Law Firm protect your rights. Just call 203-876-2711 today. You can also submit a FREE Initial Consultation Form. We know dangerous drug claims—and stand ready to help you receive the compensation you deserve.

The Carter Mario team offers decades of combined legal experience. We provide 24/7 access to our compassionate attorneys—along with our exclusive Zero Fee Warranty. With Carter Mario, you don’t owe any attorneys’ fees unless we recover on your behalf. It’s that simple. Call 203-876-2711 to find out how Carter Mario can help you today.

Get Carter! Guaranteed Tough! Guaranteed Fast!


The information presented on this website is for informational purposes only and is not intended to constitute medical or legal advice. All trademarks are property of their respective owners and are used for the purposes of product identification only. The use of any such trademarks is not intended to constitute an endorsement of any product, service, or company. This law firm is in no way associated with, sponsored by, or affiliated with any business entity, publication, governmental agency, or other organization.