In animal studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given this drug during organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose despite the presence of maternal and fetal toxicity at these doses. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, decidualization and their use resulted in increased pre and post implantation loss. 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, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy.

Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child.

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 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.

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.

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 is not recommended unless clearly needed

AU TGA pregnancy category: C
US FDA pregnancy category: B (3% gel); C prior to 30 weeks gestation; D starting at 30 weeks gestation (topical solutions, 1% gel)
US FDA pregnancy category: Not assigned

Risk Summary: NSAIDs increase the risk of premature closure of the fetal ductus arteriosus when taken after 30 weeks gestation; data from observational studies regarding embryofetal risks in the first or second trimester are inconclusive.

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

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug should not be applied to the breasts of nursing mothers.

Limited data is available on the excretion of this drug into human milk, but it appears to be low and the drug has a short half-life. Many experts feel this drug is compatible with breastfeeding, although use of other agents with more published information may be preferable.

See references