Skip to Content
Is your RA under control? Take an assessment here >

Indomethacin Pregnancy and Breastfeeding Warnings

Indomethacin is also known as: Indocin, Indocin IV, Indocin SR, Tivorbex

Medically reviewed on September 8, 2017

Indomethacin Pregnancy Warnings

Not recommended during last trimester of pregnancy.
Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C prior to 30 weeks gestation
US FDA pregnancy category: D starting at 30 weeks gestation

Comments:
-Avoid use during third trimester as it may cause premature closure of the ductus arteriosus.
-Not recommended in women attempting to conceive as may impair female fertility.

Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, platelet dysfunction, pulmonary hypertension, and gastrointestinal or intracranial bleeding. There are no controlled data in human pregnancy.

NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Indomethacin Breastfeeding Warnings

Due to low levels in breastmilk and therapeutic administration directly to infants, use is considered acceptable in nursing mothers; however, according to some manufacturers, use is not recommended. In a small study where 11 out of 15 women received doses ranging from 75 mg orally to 300 mg rectally once a day, the average concentration in breast milk was estimated to be 0.27% of the maternal weight adjusted dose. One study reported a plasma level of 47 mcg/L in 1 infant 1.2 hours after the midpoint of breastfeeding in a mother receiving 2.94 mg/kg once a day.

In a single case report in which a mother was taking 200 mg from the fourth to sixth day postpartum, the infant experienced a generalized seizure when this drug was stopped in the nursing mother, followed by a second seizure the next day. No metabolic findings accounted for convulsions and no levels of this drug were measured in mother or infant. Initially it was thought that this drug was possibly responsible for causing the seizures, however, later studies and established therapeutic use in newborns makes it unlikely that this drug caused the seizures. Due to lack of published clinical experience in newborns and preterm infants, other agents may be preferred.

AU and UK: Use is contraindicated.
US: Caution is recommended.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Indocin (indomethacin)." Merck & Co, Inc, West Point, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Indocin (indomethacin)." Merck & Co, Inc, West Point, PA.

Further information

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

Hide