Zofran (ondansetron)

Drug Class


Indication for Use

Treatment of nausea and vomiting


Birth Defects, including:

  • Cardiac defect
  • Septal defect
  • Cleft palate
  • Kidney defects
  • Neural tube defects
  • Craniosynostosis
  • Gastroschisis

Zofran is manufactured by GlaxoSmithKline and received approval in 1991 as an antiemetic for chemotherapy treatment in cancer patients and in the mid 1990’s as a treatment for post-operative nausea.

Nevertheless, Zofran has been marketed and prescribed “off-label” to pregnant women since 1998 as an anti-nausea medication.  Zofran works by inhibiting serotonin activity within the brain, and when a fetus is exposed to the drug, can lead to serious birth defects including cardiac defects, especially septal defects and cleft palate. Zofran has also been associated with other injuries including kidney defects, neural tube defects, craniosynostosis and gastroschisis.

An application is pending before the Judicial Panel on Multidistrict Litigation (JPML) for the coordination of the thousands of anticipated Zofran lawsuits.