Caliberi Adverse Reactions

Common: Dermatologic: Flushing (1% to 13%), hypersensitivity reactions, rash.
Gastrointestinal: Indigestion (1% to 13%), Nausea (up to 11%), dyspepsia, abdominal pain, vomiting, gastro-esophageal reflux.
Musculoskeletal: Backache (2.4% to 12%), Myalgia (1% to 14%).
Neurologic: Headache (3% to 42%), dizziness.
Respiratory: Nasopharyngitis (2% to 13%), Respiratory tract infection (3% to 13%), nasal congestion, dyspnea, epistaxis.
Serious: Cardiovascular: Angina (less than 2%), Chest pain (less than 2%), Heart failure, Myocardial infarction (less than 2%), Tachycardia (less than 2%), palpitations, flushing, hypotension, hypertension, peripheral edema, fatigue.
Dermatologic: Stevens-Johnson syndrome.
Neurologic: Cerebral hemorrhage, Cerebrovascular accident, Seizure.
Ophthalmic: Anterior ischemic optic neuropathy, Non-arteritic, Retinal artery occlusion, Thrombosis of retinal vein, blurred vision, sensations described as eye pain.
Otic: Decreased hearing, Sudden onset (less than 2%), Sudden hearing loss (less than 2%), tinnitus.
Hematuria.
Prolonged erections.