Kidney defects and malformations have been observed in babies exposed to Zofran when their mothers used this anti-nausea drug during pregnancy.

What is the problem?

Zofran is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for a fetus has not been well-studied.

Study Links Zofran and Kidney Defects

It has been linked to at least a 20% increased risk of major birth defects, according to a study published in Biomedical Research International in 2013. The study was too small to assess risks of individual birth defects, although there was a 6-fold increased risk of  kidney defects described as “obstructive defects of renal pelvis and ureter.”

Multiple Case Reports of Zofran Kidney Defects

In June 2014, the Toronto Star investigated reports of birth defects and found evidence of kidney malformations:

“At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations, according to a Star analysis of 2012 records.”


The kidneys are bean-shaped organs, each about the size of a fist, located near the middle of the back just below the rib cage. They are responsible for filtering blood, removing toxins and wastes, and producing urine.


One of the more common kidney defects is hydronephrosis (literally “water inside the kidneys”). It involves swelling of the kidney(s) when the flow of urine is obstructed.

Over time, high pressure inside the kidneys can cause tissue damage and kidney failure. Kidney stones and infections are also more likely.

Congenital hydronephrosis is caused by a birth defect in the urinary tract — such as the valves inside the urethra (posterior urethral valves) or other constrictions that block the ureter or urethra.

Other Types of Kidney Defects

There are also a number of birth defects involving kidney malformations, including:

  • Kidneys in the wrong place (ectopia)
  • Kidneys in the wrong position (malrotation)
  • Kidneys are joined together (horseshoe kidney)
  • Missing kidneys (kidney agenesis)
  • Cysts or fluid-filled secs inside the kidney (Polycystic Kidney Disease)
  • Medullary sponge kidney (MSK)
  • Metabolic diseases (cystinosis)
  • And more


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