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Zofran is the brand name of a medication known as Ondansetron that is used to prevent nausea and vomiting during chemotherapy treatment for cancer, radiation therapy, and post-surgery. The drug has also proven effective with gastroenteritis and dehydration. It is an off-label medication commonly used to alleviate morning sickness in pregnant women, and is also used to treat cyclic vomiting syndrome.

A recent study found that Zofran was effective in reducing symptoms of schizophrenia, a psychotic mental health disorder. Zofran is administered orally by pill or via slow injection into a vein, and functions by blocking the neurotransmitter serotonin, which tends to cause vomiting. The medication may interact with other prescribed medications and should only be taken under doctor supervision.

The World Health Organization has categorized Zofran as one of the safest and most effective medicines on the market. Nonetheless, disturbing side effects are common and more severe complications may occur.


Use of Zofran comes with the risk of a normal span of medication side effects, including headaches, diarrhea, constipation, dizziness, sleepiness, weakness, itchiness, and muscle spasms. If you experience any of these symptoms while taking Zofran, you should talk to your doctor.

More severe side effects and allergic reactions can also occur, including: fever, chills, rash, hives, swelling of lips, tongue, and/or throat, and difficulty breathing. It is very important to call your doctor if you experience any of these symptoms.

In extreme cases, Zofran has been associated with stomach pain, severe constipation, chest pain, severe dizziness and/or fainting, racing or irregular heartbeat, jaundice, and blurred vision. While these side effects are relatively rare, it is a good idea to be vigilant about monitoring your condition while taking Zofran.


A few serious complications have been noted with use of Zofran. Multiple studies have found an increase in major congenital malformations that results from increases in heart problems among babies of mothers who used Zofran for morning sickness during pregnancy.

Zofran has also caused the adverse effect of extremely high levels of serotonin, which results in hallucinations, fever, rapid heartbeat, agitation and overactive reflexes, nausea, diarrhea, vomiting, loss of coordination, and fainting. Use of Zofran has been found to sometimes cause a prolonged QT interval of the heart, resulting in a rapid and irregular heartbeat or arrhythmia of the heart, a condition known as torsades de pointes that can prove fatal. The risk of contracting this complication is most prevalent in the intravenous form of the drug, and with patients who have congestive heart failure, congenital long QT syndrome, and/or bradyarrhythmias.


Zofran can cause a host of birth defects, including kidney malformation, a cleft palate, and heart defects. Such birth defects can immeasurable emotional grief, physical pain, and hardship. These defects are often lifelong conditions that profoundly impact the life of the child, mother, and family. Zofran birth defects (and complications) include:

Cleft palate and cleft lips Congenital heart defects Kidney malformations Clubfoot Abnormal heart rhythm, or arrhythmia Heart defects, such as septal defects and tachycardia (holes in the heart) Skull and/or musculoskeletal deformities Miscarriages


As of 2018, there are approximately 500 lawsuits filed against GlaxoSmithKline, the manufacturer of Zofran, due to birth defects associated with the drug. If you have a baby or child with a birth defect and used Zofran during your pregnancy, please contact a lawyer to discuss filing a compensation claim for your hardship and suffering. No one deserves to live with an unwanted birth defect.

In 2003, the Justice Department fined GlaxoSmithKline for $3 billion dollars because they had promoted the off-label use Zofran to pregnant women for morning sickness—without issuing a warning statement about the known and very hazardous side effects of birth defects. Although the FDA had sent a letter of warning years before the lawsuit to GlaxoSmithKline stating that they needed to warn potential users about the hazards of Zofran, the company ignored the request.

Zofran lawsuits for birth defects are, therefore, based on the fact that the company mislead Zofran users. Such behavior demonstrates negligence to act with reasonable care to ensure the safety of the patient. Therefore, Zofran has been held liable for damages in multiple cases, especially those regarding birth defects and debilitating adverse reactions in pregnant mothers.


  • The company failed to ensure Zofran was safe before marketing it.
  • GlaxoSmithKline failed to warn potential users of the drug about the serious risk of its use, including birth defects.
  • GlaxoSmithKline fraudulently claimed Zofran was safe for pregnant women.
  • It is illegal to market an unapproved drug as a supposedly safe method of off-label treatment, in this case for morning sickness.
  • The company misrepresented animal studies and deceived the public and scientific community by claiming Zofran was safe when it was not.
  • The company manufactured and profited tremendously from a defective drug that has resulted in many birth defects and undue suffering and strife for a vulnerable population. .