Very common (10% or more): Drowsiness (28%)
Common (1% to 10%): Dizziness, sedation, fever, anxiety, confusion, tremor, diaphoresis, lethargy, feeling of warmth
Uncommon (% to 1%): Withdrawal symptoms after either abrupt cessation or fast tapering of the drug, headache, chills, flu syndrome, malaise, withdrawal syndrome, pallor, facial flushing, syncope, loss of concentration, insomnia, amnesia, paresthesia, agitation, vertigo, foot drop, ataxia, hypesthesia, slurred speech, hallucinations, euphoria, apathy, seizures, myoclonus
Frequency not reported: Inflammatory masses including granulomas (some of which have resulted in serous neurologic impairment including paralysis) in patients receiving continuous infusion of opioids via indwelling intrathecal catheter [ Ref ]
During clinical development for the approved indications, 18560 patients were exposed to XARELTO . These included 7111 patients who received XARELTO 15 mg or 20 mg orally once daily for a mean of 19 months (5558 for 12 months and 2512 for 24 months) to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation (ROCKET AF); 6962 patients who received XARELTO 15 mg orally twice daily for three weeks followed by 20 mg orally once daily to treat DVT or PE (EINSTEIN DVT , EINSTEIN PE), 10 mg or 20 mg orally once daily (EINSTEIN Extension, EINSTEIN CHOICE) to reduce the risk of recurrence of DVT and/or PE; and 4487 patients who received XARELTO 10 mg orally once daily for prophylaxis of DVT following hip or knee replacement surgery (RECORD 1-3).