Skip to Content
Is your RA under control? Take an assessment and find out

Sulindac Pregnancy and Breastfeeding Warnings

Sulindac is also known as: Clinoril

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. "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.

References for breastfeeding 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.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.