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Rivaroxaban Pregnancy and Breastfeeding Warnings

Rivaroxaban is also known as: Xarelto

Medically reviewed by Last updated on Jun 12, 2020.

Rivaroxaban Pregnancy Warnings

Animal studies have revealed evidence of reproductive toxicity (e.g., hemorrhagic complications) and embryofetal toxicity (e.g., post-implantation loss).

Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. There are no controlled data in human pregnancy. Thrombolytic agents may lead to placental hemorrhage and subsequent prematurity and fetal loss. Use with caution in pregnancy because of the potential for pregnancy-related hemorrhage and/or emergent delivery.

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. Some authorities consider it contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: Insufficient data exists to inform a drug-associated risk of adverse developmental outcomes.

Comments: Females with childbearing potential requiring anticoagulation should use adequate methods of contraception. Additionally, this drug can increase the risk of significant uterine bleeding potentially requiring gynecological surgery. Females of reproductive potential with history of abnormal uterine bleeding should be assessed for this risk before using this drug.

See references

Rivaroxaban Breastfeeding Warnings

AU and UK: Use is contraindicated.
US: Benefit should outweigh risk.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Xarelto (rivaroxaban)." Bayer Inc, Toronto, IA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Xarelto (rivaroxaban)." Bayer Inc, Toronto, IA.

Further information

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