XARELTO® (rivaroxaban) tablets
XARELTO® (rivaroxaban) tablets
XARELTO® (rivaroxaban) tablets
The rates of major bleeding events and any bleeding events observed in
patients in the RECORD clinical trials are shown in Table 4.
Table 4: Bleeding Events* in Patients Undergoing Hip or Knee
Replacement Surgeries (RECORD 1-3)
XARELTO 10 mg Enoxaparin†
Total treated patients
N = 4487
N = 4524
n (%)
n (%)
* Adverse reaction occurring any time following the first dose of doubleblind medication, which may have been prior to administration of
active drug, until two days after the last dose of double-blind study
medication
† Includes the placebo-controlled period of RECORD 2, enoxaparin
dosing was 40 mg once daily (RECORD 1-3)
Other clinical trial experience: In an investigational study of acute
medically ill patients being treated with XARELTO 10 mg tablets, cases of
pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis
were observed.
Postmarketing Experience: The following adverse reactions have been
identified during post-approval use of rivaroxaban. Because these
reactions are reported voluntarily from a population of uncertain size, it
is not always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure.
Blood and lymphatic system disorders: agranulocytosis, thrombocytopenia
Gastrointestinal disorders: retroperitoneal hemorrhage
Hepatobiliary disorders: jaundice, cholestasis, hepatitis (including
hepatocellular injury)
Immune system disorders: hypersensitivity, anaphylactic reaction,
anaphylactic shock, angioedema
Nervous system disorders: cerebral hemorrha