Can I take rivaroxaban while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary The limited available data on rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of rivaroxaban for the mother and possible risks to the fetus when prescribing rivaroxaban to a pregnant woman [see Warnings and Precautions (5.2 , 5.7 )]. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Rivaroxaban (oral), Novadoz Pharmaceuticals LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Several case reports, a thorough pharmacokinetic analysis, and a pharmacokinetic computer model consistently indicate that maternal doses of rivaroxaban of 15 to 30 mg daily produce low levels in milk that are considerably below doses (7% or less) required for anticoagulation in infants. Plasma rivaroxaban levels in two breastfed infants were undetectable. If the mother requires rivaroxaban, it is not a reason to discontinue breastfeeding.[1,2]

“Summary of Use during Lactation”, LactMed record “Rivaroxaban” (LM1169), quoted verbatim. Everything LactMed reports about Rivaroxaban while breastfeeding.

8.2 Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rivaroxaban and any potential adverse effects on the breastfed infant from rivaroxaban or from the underlying maternal condition (see Data).

Prescribing label, section “8.2 Lactation” (opening excerpt): Rivaroxaban (oral), Novadoz Pharmaceuticals LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.