利伐沙班常见不良反应

The safety of rivaroxaban 10 mg was evaluated in three phase III studies in which a total of 4571 patients undergoing major lower extremity orthopedic surgery (total hip replacement or total knee replacement) received rivaroxaban for up to 39 days.

A total of approximately 14% of treated patients experienced adverse reactions. Bleeding and anemia occurred in approximately 3.3% and 1% of patients, respectively. Other common adverse reactions include nausea, increased GGT, and increased transaminases.

The following table lists adverse reactions in the three phase III studies according to system organ class (MedDRA) and frequency of occurrence. Common: ≥1/100 to <1/10, Uncommon: ≥1/1000 to <1/100, Rare: ≥1/10000 to <1/1000, Very Rare: <1/10000, Unknown: Unable to estimate based on available data.

Elevated γ-glutamyl transpeptidase and elevated transaminase (including elevated alanine aminotransferase and elevated aspartate aminotransferase) are common; rarely elevated lipase, amylase, blood bilirubin, lactate dehydrogenase, and alkaline phosphatase; rare elevated conjugated bilirubin (with or without elevated alanine aminotransferase).

Heart abnormalities: Rarely tachycardia. Blood and lymphatic system abnormalities: common anemia (including corresponding laboratory parameters); rare thrombocytosis (including elevated platelet count). Nervous system diseases: syncope (including loss of consciousness), dizziness, and headache are rare. Gastrointestinal abnormalities: nausea is common; constipation, diarrhea, abdominal and gastrointestinal pain (including upper abdominal pain, stomach discomfort), indigestion (including upper abdominal discomfort), dry mouth, and vomiting are rare.

Renal and urinary system abnormalities: rare renal damage (including elevated blood creatinine and elevated blood urea). Skin and subcutaneous tissue abnormalities: Rarely pruritus (including rare generalized urticaria), rash, urticaria (including rare generalized urticaria), bruises. Abnormalities of the musculoskeletal system: Rarely, extremity pain. Complications of injury, poisoning and surgery: Wound discharge is rare.

Vascular abnormalities: common postoperative bleeding (including postoperative anemia and wound bleeding); rare bleeding (including hematoma and rare muscle bleeding), gastrointestinal bleeding (including gum bleeding, rectal bleeding, hematemesis), hematuria (including the occurrence of hematuria), reproductive tract bleeding (including menorrhagia), hypotension (including blood pressure drop, hypotension caused by surgery), epistaxis; internal bleeding in unknown key organs (such as the brain), adrenal bleeding, conjunctival hemorrhage, and hemoptysis. Abnormalities of the body and administration site: local edema, peripheral edema, discomfort (including fatigue, weakness), and fever are rare. Immune system abnormalities: Rare allergic dermatitis; unknown hypersensitivity reactions. Hepatobiliary abnormalities: Rare liver function abnormalities; unknown jaundice.