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Zofran and Hypospadia


Studies have found case reports linking Zofran with hypospadia, a urethral birth defect in boys that usually requires corrective surgery.

Zofran and Hypospadia

In 2004, a study found case reports linking Zofran and hypospadia. The study was published in the medical journal BJOG, titled “The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study.”  Click here to read more.

Conclusions of the study were based on data from 176 pregnant women who used Zofran during the first trimester. Six babies (3.6%) were born with a major birth defect, including three babies that had mild-moderate hypospadia. This rate was higher than would be expected in the general population, but the study was too small to conclude that Zofran increased the risk of hypospadia.

Furthermore, evidence linking the maternal use of Zofran and hypospadia is conflicting. Another study published in 2011 by Birth Defects Research found no evidence linking Zofran and hypospadia. However, the study did link Zofran and a 2.4-fold increased risk of cleft palate.


Hypospadia is a congenital birth defect that occurs when the opening of the urethra (tube that carries urine out of the body) is located somewhere other than the tip of the penis.

Types of Hypospadia

  • Subcoronal: Located just under the head of the penis (50-75% of cases)
  • Midshaft: Located along the shaft of the penis.
  • Penoscrotal: Located where the penis meets the scrotum.

In extremely rare cases, hypospadia occurs at the base of the scrotum. It may also occur with chordee, or extreme downward curvature of the penis due to incomplete separation from the perineum or undescended testicles.

What is the problem?

Hypospadia is not life-threatening but it can cause a number of complications, which become more serious as the boy ages. Depending on the location of the opening, spraying of urine can be a problem and he may need to sit down while urinating. Hypospadia can also cause a number of sexual problems, especially if it is accompanied by curvature of the penis.


Corrective surgery is usually recommended when the boy is 3-18 months old. In some cases, hypospadia must be treated in stages — moving the urethra, correcting curvature, and repairing skin around the urethra. Doctors may recommend against circumcision so the foreskin can be used to repair the hypospadia.


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