FAQ: What Pregnancy Category Is Zofran?

Is it safe to take Zofran while pregnant?

Zofran is approved by the Food and Drug Administration (FDA) for use to fight off nausea related to chemotherapy. It is not currently approved by the FDA for morning sickness. Even so, most studies show that ondansetron is safe to use during the first trimester when most women experience morning sickness.

Is ondansetron safe in early pregnancy?

Ondansetron. Although ondansetron has limited safety data in pregnancy, it is often prescribed for women with hyperemesis gravidarum. It is not recommended as first-line therapy, especially in the first trimester of pregnancy. Ondansetron commonly causes constipation, which may already be a problem in pregnancy.

Can you take Category B drugs while pregnant?

Category B drugs include prenatal vitamins, acetaminophen and several other medications used routinely and safely during pregnancy. If there is a clinical need for a Category B drug, it is considered safe to use it.

Can Zofran cause birth defects?

Does taking ondansetron increase the chance of birth defects? Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Most studies have found no increased chance for birth defects among thousands of people who used ondansetron in the first trimester of pregnancy.

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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.

How often can you take Zofran 8 mg while pregnant?

Ondansetron can be given orally or intravenously in doses up to 8 mg three to four times daily.

Why is Zofran contraindicated in pregnancy?

It has been used off-label to treat nausea and vomiting in pregnancy. Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy.

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 ondansetron cause miscarriage?

There are no concerns that ondansetron use in pregnancy affects the chance of miscarriage, stillbirth, preterm delivery or low infant birth weight.

Which pregnancy category is the riskiest?

Category X: Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk. The drug is contraindicated in women who are or may become pregnant.

Is Category C safe for pregnancy?

Category C: Studies in animals have revealed adverse effects on the fetus and there are no controlled studies in women, or studies in women and animals are not available. Drugs from this class can be given to pregnant women if the benefit to the mother outweighs the risk to the fetus.

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Which antifungal is safe in pregnancy?

Careful consideration of the benefit to the mother and the risk to the fetus is required when prescribing antifungal therapy in pregnancy. Imidazoles are considered safe as topical therapy for fungal skin infections during pregnancy. Nystatin is minimally absorbed and is effective for vaginal therapy.

What does Zofran do during pregnancy?

Ondansetron (Zofran®) is a medicine used to treat nausea and vomiting that may be caused by surgery, chemotherapy, or radiation therapy. Healthcare professionals also prescribe ondansetron during pregnancy to reduce symptoms of nausea and vomiting, also known as “morning sickness.”

Can Zofran cause heart defects in babies?

Specifically, the study found that there was a 160 percent increase in heart defects in infants born to women who took Zofran during pregnancy compared to those who did not. The dangers of Zofran during pregnancy are even more pronounced with regard to the increased risk for septal birth defects.

Why was Zofran taken off the market?

WASHINGTON — The 32-mg dose of the anti-nausea drug ondansetron (Zofran) has been pulled from the market because of concerns about cardiac problems, the FDA announced Tuesday. Ondansetron is approved for preventing chemotherapy-induced nausea and vomiting, and, in lower doses, for postoperative nausea and vomiting.

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