Zofran and Serotonin Syndrome

Posted on May 5, 2016

Zofran, pharmaceutical giant GlaxoSmithKline’s (GSK) brand name for the drug ondansetron, was approved by the U.S. Food and Drug Administration (FDA) in 1998. GlaxoSmithKline then began marketing Zofran as a remedy for morning sickness in pregnant women—a use for which the FDA had not approved the drug.

The medication was then linked in studies to a plethora of birth defects, including cleft palate, renal atresia (born without one or both kidneys), and the congenital heart defects atrial septal defect, ventricular septal defect, and atrioventricular septal defect. Zofran has also been linked to another side effect, serotonin syndrome.

Serotonin syndrome is a serious health issue that occurs when there is too much of the neurotransmitter serotonin in the body. Symptoms of serotonin syndrome include:

  • Confusion
  • Agitation
  • Restlessness
  • Rapidly beating heart
  • Hypertension (also known as high blood pressure)
  • Pupil dilatation
  • Loss of muscle coordination
  • Twitching of muscles
  • Muscle rigidity
  • Excessive sweating
  • Diarrhea
  • Headaches
  • Shakiness
  • Shivering
  • Goose bumps

Symptoms of serotonin syndrome will discontinue once serotonin levels return to normal. But, if left untreated, the serotonin syndrome can lead to unconsciousness and even death.

While taking Zofran alone has been known to cause serotonin syndrome in some cases, it most often occurs when the medication is combined with other medications, such as Prozac (fluoxetine) and other selective serotonin reuptake inhibitor antidepressants. Certain migraine medications can also cause serotonin syndrome when taken with Zofran.

If you were prescribed Zofran and experienced serotonin syndrome or any other side effect, you may be able to pursue compensation for any injuries you suffered. To find out more about your legal rights and obligations, you’ll need to consult a knowledgeable pharmaceutical litigation attorney. The seasoned legal team at the law offices of Farah & Farah has been successfully representing injury victims since 1979. Farah & Farah is currently investigating Zofran related injuries nationwide. Call us today at (800) 533-3555 for a free, no obligation consultation.


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