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Montelukast Pregnancy and Breastfeeding Warnings

Montelukast is also known as: Singulair

Medically reviewed on December 25, 2017

Montelukast Pregnancy Warnings

Animal studies showed no adverse effects on embryofetal development at oral doses up to 400 mg/kg/day in rats or up to 100 mg/kg/day in rabbits. Retardation of fetal growth and development was observed in rabbits dosed at 200 mg/kg/day, a dose level associated with severe maternal toxicity. Fetal exposure of montelukast was demonstrated in both species. During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated with this drug during pregnancy. Most of these women were also taking other asthma medications during their pregnancy. A causal relationship between these events and this drug has not been established. There are no controlled data in human pregnancy".

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

See references

Montelukast Breastfeeding Warnings

This drug should be used only if clearly needed. Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: : The effects in the nursing infant are unknown.

Studies in lactating rats have shown that this drug is excreted into milk following oral doses of 100 and 200 mg/kg/day, and growth of the pups was slightly inhibited at the higher dose level.

See references

References for pregnancy information

  1. "Product Information. Montelukast Sodium (montelukast)." Ajanta Pharma USA, Bridgewater, NJ.
  2. "Product Information. Singulair (montelukast)." Merck & Co, Inc, West Point, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Sarkar M, Koren G, Kalra S, et al. "Montelukast use during pregnancy: a multicentre, prospective, comparative study of infant outcomes." Eur J Clin Pharmacol 65 (2009): 1259-64

References for breastfeeding information

  1. "Product Information. Montelukast Sodium (montelukast)." Ajanta Pharma USA, Bridgewater, NJ.
  2. "Product Information. Singulair (montelukast)." Merck & Co, Inc, West Point, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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