Zofran Side Effects

What is Zofran? What was it used for?

Zofran is a drug that was primarily taken orally to help with the symptoms of nausea and vomiting related to chemotherapy.  It also has the name Ondansetron.  However it was also prescribed “off-label” for nausea and vomiting during pregnancy (morning sickness).

Recently it has come out that Zofran and possibly the generic versions might be connected with birth defects such as Cleft palate and Heart defects in children.  Zofran was also the subject of a Potential Signal of serious side effect by the FDA in 2013.  That was related to Serotonin syndrome.

Birth Defects

What birth defects might be related to Zofran?

  • Cleft Palate
  • Heart Defects

A study that looked at women in Denmark from 1997 to 2010 concluded that there was a 2 fold increase in cardiac malformations.  A different study involving the CDC concluded that ther ewas a 2 fold increase in risk for cleft palate as well.

Has the FDA issued any warnings on this drug?

Yes,  in 2013 the FDA issued a warning relating to potential side effects of seratonin syndrome.

Has Zofran caused your child’s birth defects?

Background Information on Zofran

Zofran was developed in the 1980s by GlaxoSmithKline.  It received Patent protection in 1987 and 1988 and was approved by the FDA in the US in 1992.  It was approved to treat nausea and vomiting in chemotherapy and radiation patients as well as post surgical patients.

Are there Generic versions of this drug?

Yes. Two companies make generic versiosn of the drug, Teva Pharmaceuticals and SICOR.

Has Zofran been recalled?

No.  Zofran has not been recalled.  A product or drug like this can be the subject of lawsuits for injuries and not be recalled.  A recall will be something that the government issues.  That would be a long time, if at all, in this case.

What does ‘Off-Label” mean?

Sometimes a drug is approved for one use and then is used for another in addition to its approved use.  The additional use is called off-label.

Has Zofran caused your child’s birth defects?

(800) 838-0800


When did the lawsuits start?

These lawsuits are just getting started.  What will probably happen soon is that these cases (or some of them) will be consolidated in only a few courts around the country.  There will probably be a Federal Court MDL and a few state courts who have cases moving forward.

Have any gone to Trial yet?

No.  All of this has started recently.  It will be a while before these cases get to trial.  It could be a couple of years before the first case goes to trial.

Is this a class action?

No.  Each person has their own case.  The cases may be put together so that the courts can deal with them all efficiently, but it is not a class action.

Is there a Time Limit to file these cases?

Yes, there is a time limit.  That limit is different in different states.  It could be several years though because these injuries happened to children.  Because the cases involve children, the time limits are often longer.  The only way to get a solid answer on how much time you have is to talk to a lawyer about your specific case.

Will my Doctor be involved in the case?

As of now these cases are only against the manufacturer, GlaxoSmithKline.


Have there been any settlements?

Not that we are aware of. Settlements usually only happen after several cases have gone to trial

How much is my case worth?

No one knows yet.  It is too early to tell.  Case values are really determined by trial verdicts and a lot of other factors.

  • How strong is the science to prove the case
  • What kind of injuries did someone have
  • Whether the company is in a position to settle

How long before the case will settle?

If it settles, it will likely be several years.  You have to be patient because these cases can take a very long time.