Zofran (ondansetron) is an antiemetic medication, used to treat and protect against nausea and vomiting.  Zofran was the first in a class of drugs known as serotonin-3 (5-HT3) receptor antagonists to prevent nausea and vomiting caused by cancer chemotherapy, radiation treatment and surgery.  It’s not and never has been approved to be used in pregnant women, but for several years it was prescribed off-label to deal with nausea and vomiting of pregnancy (NVP).

Zofran Uses

Zofran was approved by the U.S. Food and Drug Administration (FDA) in 1991. It is approved for the following uses:

  • Prevent nausea and vomiting caused by chemotherapy treatment for cancer
  • Prevent nausea and vomiting caused by radiation therapy
  • Prevent post-surgical nausea and vomiting

Zofran Side Effects

The following side effects have been associated with Zofran use:

  • Serotonin syndrome
  • QT prolongation
  • Blurred vision
  • Temporary vision loss
  • Severe dizziness
  • Shortness of breath
  • Difficulty breathing
  • Fainting
  • Fast or pounding heartbeats
  • Slow heart rate
  • Anxiety
  • Agitation
  • Shivering
  • Fainting
  • Seizures
  • Urinating less than usual or not at all
  • Diarrhea
  • Constipation
  • Fever
  • Headache

Serotonin syndrome occurs when high levels of serotonin accumulate in your body. It is a medical emergency and can be life-threatening.

QT prolongation is an electrical disturbance in the heart that can cause serious irregular heart rhythms. It can be fatal.

Zofran Off-Label

The FDA only approves drugs for specific purposes. When a medication is used for every other purpose, it’s known as “off-label”.  Doctors are allowed to prescribe medication off-label, when they believe it’s in the best interests of the patients.  Drug companies, on the other hand, aren’t permitted to advertise their products for off-label functions.

Zofran is occasionally prescribed off-label to treat acute gastroenteritis in children.

For many years, Zofran was also prescribed off-label to deal with morning sickness in pregnant women.  In 2012, the manufacturer reached a settlement deal with the authorities concerning the marketing of numerous pharmaceutical products.  There were no findings that the manufacturer illegally marketed Zofran and the manufacturer did not admit wrongdoing or agree to plead guilty with respect to the marketing of Zofran.

Dangers of Zofran Use in Pregnancy

Zofran use during pregnancy can cause harm to the fetus and birth defects including:

  • Fetal death
  • Fetal growth restriction
  • Congenital heart malformations
  • Hypospadias
  • Heart murmurs
  • Orofacial clefts
  • Skeletal abnormalities
  • Skull deformities
  • Kidney malformation
  • Jaundice
  • Clubbed foot
  • Vision problems
  • Hearing loss

If you have questions about Zofran that are not answered here or believe your child’s birth defect was caused by Zofran, please email us or call us toll-free at 1-800-HURT-NOW.  We will help you find answers to your questions and we can refer you to an attorney who represents families of children with birth defects.