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Oxaprozin Pregnancy and Breastfeeding Warnings

Oxaprozin is also known as: Daypro, Daypro Alta

Medically reviewed on September 14, 2017

Oxaprozin Pregnancy Warnings

Animal studies have revealed evidence of increased pre- and post implantation loss following administration of prostaglandin synthesis inhibitors during pregnancy. Infrequent malformed fetuses were observed at doses of 7.5 mg/kg/day or higher (0.1 times maximum recommended human daily dose). There are no controlled data in human pregnancy. Testicular degeneration was observed in beagle dogs treated with 37.5 mg/kg/day for 42 days or 6 months (0.7 times maximum recommended human daily dose based on body surface area).

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

Administration during labor and delivery is not recommended; onset of labor may be delayed and the incidence of stillbirths may increase.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Avoid use during third trimester of pregnancy.
Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

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

Oxaprozin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

Due to lack of published clinical experience during breastfeeding, other agents may be preferred.

See references

References for pregnancy information

  1. "Product Information. Daypro (oxaprozin)." Searle, Skokie, IL.

References for breastfeeding information

  1. "Product Information. Daypro (oxaprozin)." Searle, Skokie, IL.
  2. 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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