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Sulindac Pregnancy and Breastfeeding Warnings

Sulindac is also known as: Clinoril

Medically reviewed on September 14, 2017

Sulindac Pregnancy Warnings

Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, oligohydramnios, 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.

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

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.

See references

Sulindac Breastfeeding Warnings

Use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

Due to its long half-life and lack of published clinical experience during breastfeeding, other agents may be preferred.

See references

References for pregnancy information

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

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Clinoril (sulindac)." Merck & Co, Inc, West Point, PA.
  4. 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 -]):

Further information

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

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