The use of Zofran in the first trimester of pregnancy has been linked to an increased risk of birth defects, including several cases of hypospadia.

Evidence Linking Zofran and Hypospadia

In 2004, a study published in the medical journal BJOG reported several cases of hypospadia associated with Zofran.

Researchers observed outcomes of 176 pregnancies where Zofran was used in the first three months of pregnancy. There were 169 live births, 5 miscarriages, and 6 babies born with major birth defects (3.6%).

Three cases of minor-moderate hypospadias were observed, which is higher than the expected number (1 in 300 boys). However, the study was too small to draw any conclusions about whether Zofran causes hypospadias or birth defects overall. Click here to read more.

The link between Zofran and hypospadia is uncertain. Another study, published in Birth Defects Research in 2011, found no evidence that Zofran increased the risk of hypospadia. However, they did found that Zofran more than doubled the risk of having a baby with cleft palate.

What is Hypospadia?

Hypospadia is a birth defect in boys that occurs when the opening of the urethra is not located at the tip of the penis. The urethra is the tube that carries urine from the bladder to the outside of the body.

Where Does Hypospadia Occur?

  • Subcoronal: Opening of the urethra located near the head of the penis.
  • Midshaft: Opening of the urethra located along the shaft of the penis.
  • Penoscrotal: Opening of the urethra located where the penis and scrotum meet.


Hypospadia is not a life-threatening birth defect, but it can cause a number of serious complications. Boys with hypospadia sometimes have a curved penis. They may need to sit while urinating due to spraying of urine. Later in life, hypospadia can cause problems with sexual intercourse.


Most cases of hypospadia need to be treated with surgery, often when the boy is between the ages of 3-18 months. Severe cases may need to be treated in stages to move the opening of the urethra, correct curvature of the penis, and repair the skin around the urethra.


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