Very common (≥1/10): Infections and infestations: upper respiratory infection.
Common (≥1/100 to <1/10): Gatrointestinal disorders: diarrhea, nausea, vomiting.
Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST).
Skin and subcutaneous tissue disorders: rash.
General disorders and administration site conditions: pyrexia.
Uncommon (≥1/1000 to < 1/100): Immune system disorders: hypersensitivity reactions including anaphylaxis.
Psychiatric disorders: dream abnormalities including nightmares, insomnia, somnambulism, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression.
Nervous system disorders: dizziness, drowsiness, paresthesia/hypoesthesia, seizure.
Respiratory, thoracic and mediastinal disorders: epistaxis.
Gastrointestinal disorders: dry mouth, dyspepsia.
Skin and subcutaneous tissue disorders: bruising, urticaria, pruritus.
Musculoskeletal, connective tissue and bone disorders: arthralgia, myalgia including muscle cramps.
General disorders and administration site conditions: asthenia/fatigue, malaise, edema.
Rare (≥1/10,000 to <1/1000): Blood and lymphatic system disorders: increased bleeding tendency.
Psychiatric disorders: tremor, disturbance in attention, memory impairment.
Cardiac disorders: palpitations.
Skin and subcutaneous tissue disorders: angioedema.
Very rare (<1/10,000): Blood and lymphatic system disorders: thrombocytopenia.
Immune system disorders: hepatic eosinophilic infiltration.
Psychiatric disorders: hallucinations, suicidal thinking and behavior (suicidality), disorientation.
Respiratory, thoracic and mediastinal disorders: Churg-Strauss syndrome (CSS), pulmonary eosinophilia.
Hepatobiliary disorders: hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders: erythema nodosum, erythema multiforme.
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