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Does ondansetron cause cleft palate?

Author

James Craig

Updated on February 20, 2026

Does ondansetron cause cleft palate?

Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy. Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.

Beside this, does Zofran cause cleft palate?

Women suffering from extreme morning sickness often take Zofran (ondansetron) to combat their debilitating nausea and vomiting. However, two studies have found that the drug may increase risk of heart defects and cleft palate in children exposed in utero.

Furthermore, does Zofran really cause birth defects? The results of these studies have concluded Zofran causes birth defects, particularly congenital heart defects, cleft palate defects, and kidney defects. The birth defects linked to use of Zofran during pregnancy include: 130% risk of overall birth defects.

Hereof, is it safe to take ondansetron while pregnant?

Although not specifically approved by the FDA for the management of nausea and vomiting during pregnancy, ondansetron is now commonly used during pregnancy.

What are the risks of taking Zofran while pregnant?

Taking Zofran while pregnant is low risk, and it has been prescribed for years for pregnancy nausea.

Side effects associated with Zofran include:

  • headache.
  • diarrhea.
  • constipation.
  • weakness.
  • tiredness.
  • dizziness.

What stage of pregnancy does cleft palate develop?

What is Cleft Palate? The roof of the mouth (palate) is formed between the sixth and ninth weeks of pregnancy. A cleft palate happens if the tissue that makes up the roof of the mouth does not join together completely during pregnancy.

Can people with a cleft palate talk?

A child with a cleft lip may not have many speech problems. A child with a cleft palate may need to work with an SLP. They may need help learning to make sounds and speak clearly. Some children have problems with their soft palate.

How early can they detect cleft palate?

How is cleft lip/cleft palate diagnosed? In most cases, a prenatal ultrasound can detect cleft lip alone or cleft lip and palate as early as 16 weeks into a pregnancy. The diagnosis is then confirmed at birth with a detailed visual assessment and physical examination.

Is Zofran safe at 8 weeks pregnant?

A new study published in the New England Journal of Medicine concluded that the popular drug Zofran (used to treat nausea, vomiting and in some cases, hyperemesis gravidarum, in early pregnancy) poses no risk to the developing fetus.

Can folic acid prevent cleft lip?

A new study finds that women who take folic acid supplements early in their pregnancy can substantially reduce their baby's chances of being born with a facial cleft.

Is there a lawsuit against Zofran?

Currently, the Zofran lawsuit is still on-going. In 2012, GlaxoSmithKline pled guilty to criminal charges lodged by the United States Department of Justice for its off-label promotion of Zofran for uses never approved by the FDA.

Does Zofran cause heart defects?

Zofran during pregnancy can cause heart defects such as VSD or “hole in the heart” defects. Use of Zofran (Ondansetron) during pregnancy was investigated by researchers at the Copenhagen University at the Department of Clinical Pharmacology and was found to increase the risk of cardiac birth defects.

Can I take Zofran on an empty stomach?

Ondansetron can be taken with or without food. The first dose of ondansetron is usually taken before the start of your surgery, chemotherapy, or radiation treatment.

How quickly does ondansetron work?

Ondansetron for nausea and vomiting sickness. Ondansetron is an anti-sickness medicine. It will start to work within 1-2 hours. The most common side-effects are a headache, constipation, and feeling flushed.

Can ondansetron cause miscarriage?

Currently, no scientific evidence has linked the anti-nausea drug Zofran, frequently prescribed “off-label” for morning sickness, to an increased risk of miscarriage.

What nausea medicine is safe while pregnant?

In fact, the FDA has approved a prescription medication for use during pregnancy that is a combination of Vitamin B6 and Unisom. It is called Diclegis. This is the only FDA approved medication for treating nausea and vomiting during pregnancy.

What are the side effects of ondansetron?

Ondansetron may cause side effects.Tell your doctor if any of these symptoms are severe or do not go away:
  • headache.
  • constipation.
  • weakness.
  • tiredness.
  • chills.
  • drowsiness.

What pregnancy category is ondansetron?

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Can ondansetron be addictive?

Drug Abuse And Dependence

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Is Zofran used for anxiety?

Zofran (ondansetron) and Compazine (prochlorperazine) are prescribed for the treatment of nausea and vomiting. Zofran is often used to prevent and treat nausea and vomiting during chemotherapy and after surgery. Compazine is also used to treat psychotic disorders such as schizophrenia and anxiety.

Why am I still nauseous after taking Zofran?

The mechanism of the drug involves blocking serotonin, which can cause vomiting. Doctors will look at your liver health and weight when deciding how much of the drug you should take. While Zofran can offer relief to some patients who can't eat or struggle with chronic nausea, it can also create severe side effects.

What drug class is ondansetron?

5-HT3 antagonist

How long does 4mg Zofran last?

Zofran (ondansetron) lasts about eight hours. It begins to work quickly and reaches peak concentration in about two hours. To prevent nausea, the dose is usually repeated eight hours after the first one. Some people continue this Zofran dosage for 1 to 2 days following chemotherapy or radiation.

Does Zofran cross the placenta?

2. Does Zofran Pass The Placental Barrier To A Significant Degree? Yes. We've already covered how Zofran is able to cross the fetal placental barrier, and was found in both human and animal fetal tissue at high concentrations.

Can you take Tylenol with Zofran while pregnant?

Interactions between your drugs

No interactions were found between Tylenol and Zofran. This does not necessarily mean no interactions exist. Always consult your healthcare provider.

Is Zofran bad for kidneys?

Conducted by researchers from the University of Western Australia, the study found evidence that women prescribed Zofran during early pregnancy may be up to 7 times more likely to have babies with kidney defects. These results, however, have been highly-contested.

How safe is Zofran?

Zofran may cause headaches, drowsiness, constipation and other mild side effects. In rare cases, the anti-nausea medication can cause erratic heartbeats and high serotonin levels, which may be life-threatening. The drug has also been said to cause birth defects, though research findings are mixed.

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