Rivaroxaban is contraindicated in patients with hypersensitivity to rivaroxaban or any excipient of the tablet (see Description).
Rivaroxaban is contraindicated in patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding).
Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk (see Pharmacology: Pharmacokinetics under Actions).
Safety and efficacy of Rivaroxaban have not been established in pregnant women. Animal data show that rivaroxaban crosses the placental barrier. Therefore, use of Rivaroxaban is contraindicated throughout pregnancy (see Use in Pregnancy & Lactation, Pharmacology: Toxicology: Preclinical safety data under Actions).
Safety and efficacy of Rivaroxaban have not been established in nursing mothers. Animal data indicate that rivaroxaban is secreted into breast milk. Therefore, Rivaroxaban may only be administered after breastfeeding is discontinued (see Use in Pregnancy & Lactation, Pharmacology: Toxicology: Preclinical safety data under Actions).
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