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Rivaroxaban Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jun 2, 2022.

Rivaroxaban is also known as: Xarelto

Rivaroxaban Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity. After pregnant rabbits were given oral doses of at least 10 mg/kg (dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the recommended human dose of 20 mg/day) during organogenesis, increased fetal toxicity (increased resorptions, decreased number of live fetuses, decreased fetal body weight) was observed. Fetal body weights decreased after pregnant rats were give oral doses of 120 mg/kg (dose corresponds to about 14 times the human exposure of unbound drug) during organogenesis; peripartal maternal bleeding and maternal and fetal death occurred at 40 mg/kg (about 6 times maximum human exposure of unbound drug at the human dose of 20 mg/day). This drug crosses the placenta in animals; in an in vitro placenta perfusion model, unbound drug was rapidly transferred across the human placenta. There are no controlled data in human pregnancy.

Pregnancy is a risk factor for venous thromboembolism; that risk is increased in women with inherited/acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications (including preeclampsia); maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption, and pregnancy loss (early and late).

Based on the pharmacologic activity of factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.

All patients receiving anticoagulants (including pregnant patients) are at risk for bleeding; this risk may be increased during labor or delivery. The bleeding risk should be balanced with the risk of thrombotic events when considering the use of this drug in this setting.

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 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug should be used with caution in pregnant patients due to the potential for pregnancy-related hemorrhage and/or emergent delivery; the anticoagulant effect of this drug cannot be reliably monitored with standard laboratory testing.
-The benefits and risks for the mother and possible risks to the fetus should be considered when prescribing this drug during pregnancy.
-Disease-associated maternal and/or embryofetal risk, fetal/neonatal adverse reactions, and risks during labor/delivery should be considered.
-Patients of childbearing potential who require anticoagulation should discuss pregnancy planning with their physician; the risk of clinically significant uterine bleeding (potentially requiring gynecological surgical interventions) seen with oral anticoagulants (including this drug) should be assessed in patients of childbearing potential and those with abnormal uterine bleeding.
---According to some authorities: This drug should be used in patients of childbearing potential only with effective contraception; patients of childbearing potential should avoid becoming pregnant during therapy.

See references

Rivaroxaban Breastfeeding Warnings

If this drug is required by the mother, it is not a reason to discontinue nursing; because data are limited, preterm or newborn infants should be monitored for signs of bleeding.
-According to some authorities: Use is contraindicated; a decision should be made to discontinue breastfeeding or discontinue the drug.

Excreted into human milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

Several case reports consistently showed that maternal doses of 15 to 30 mg/day produced low levels in milk that were considerably below doses required for anticoagulation in infants.

A 40-year-old woman developed bilateral pulmonary embolism and peripartum cardiomyopathy after cesarean section; after initially receiving enoxaparin, she was switched to this drug (15 mg orally twice a day) after 2 days. On the third day of this drug, complete milk collections from both breasts were obtained before and at 3, 6, and 10 hours after the morning dose; blood samples were collected at the same times. According to author calculation, a fully breastfed infant would receive 2.4 mcg/kg over the 10-hour period, which would be 1.3% of the maternal weight-adjusted dosage.

A 38-year-old woman with antiphospholipid syndrome began 15 mg/day (0.19 mg/kg/day) at 5 days postpartum for prophylaxis of deep vein thrombosis; she partially breastfed her infant (at least 50%). On 2 separate days, 7 samples of milk were collected over a 24-hour period; values were similar at the same times on each day. A mean peak value of 53.9 mcg/L occurred at 6 hours after dosing and the milk level averaged 22.7 mcg/L; the half-life in milk was 4.7 hours. A fully breastfed infant would receive 3.4 mcg/kg/day (estimated), which corresponded to 1.8% of the maternal weight-adjusted dosage. No apparent evidence of bleeding was noted in the infant at 1- and 3-month checkups and development was normal at 18 months of age.

This drug was prescribed to 2 postpartum women, 1 for stroke and the other for pulmonary embolism; each began therapy with 15 mg twice a day for 21 days, then 20 mg once a day. Both patients provided several steady-state milk samples over the dosage interval during each regimen. After the 15 mg dose, a mean peak value of 300 mcg/L occurred 1 hour after dosing and the milk level averaged 160 mcg/L; a fully breastfed infant would receive 10 mcg/kg every 12 hours (estimated), which corresponded to 5% of the maternal weight-adjusted dosage. After the 20 mg dose, a mean peak value of 260 mcg/L occurred 2 hours after dosing and the milk level averaged 70 mcg/L; a fully breastfed infant would receive 10 mcg/kg/day (estimated), which corresponded to 4% of the maternal weight-adjusted dosage.

At 8 months postpartum, 2 nursing mothers received a single 20 mg oral dose; blood and milk samples were collected before the dose and at 2.5, 6, 10, 12, and 24 hours after the dose. The peak drug milk level of about 90 mcg/L occurred at 2.5 hours after the dose. The milk level over 24 hours averaged 28.9 mcg/L, which corresponded to an infant dosage of 4.3 mcg/kg/day and a relative infant dose of 1.63% of the maternal weight-adjusted dosage. The daily dosage of this drug in milk was about 0.7% of the estimated infant daily dosage required for anticoagulation.

See references

References for pregnancy information

  1. "Product Information. Xarelto (rivaroxaban)." Janssen Pharmaceuticals (2022):
  2. "Product Information. Xarelto (rivaroxaban)." Bayer Australia Ltd (2020):
  3. "Product Information. Xarelto (rivaroxaban)." Bayer Plc (2022):

References for breastfeeding information

  1. "Product Information. Xarelto (rivaroxaban)." Janssen Pharmaceuticals (2022):
  2. National Library of Medicine (US), National Center for Biotechnology Information "Rivaroxaban - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK500742/"
  3. "Product Information. Xarelto (rivaroxaban)." Bayer Australia Ltd (2020):
  4. "Product Information. Xarelto (rivaroxaban)." Bayer Plc (2022):

Further information

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