Roacta Adverse Reactions

Cardiovascular: Chest pain, edema, flushing, palpitation, stroke, syncope, tachycardia, vascular thrombotic disease.
Central nervous system: Aggressive behavior, depression, dizziness, drowsiness, emotional instability, fatigue, headache, insomnia, lethargy, malaise, nervousness, paresthesia, pseudotumor cerebri, psychosis, seizure, stroke, suicidal ideation, suicide attempts, suicide, violent behavior.
Dermatologic: Abnormal wound healing, acne fulminans, alopecia, bruising, cheilitis, dry nose, dry skin, eczema, eruptive xanthomas, facial erythema, fragility of skin, hirsutism, hyperpigmentation, hypopigmentation, increased sun-burn susceptibility, nail dystrophy, paronychia, peeling of palms, peeling of soles, photoallergic reactions, photosensitizing reactions, pruritus, purpura, rash.
Endocrine and metabolic: Triglycerides increased (25%), abnormal menses, blood glucose increased, cholesterol increased, HDL decreased, hyperuricemia.
Gastrointestinal: Bleeding and inflammation of the gums, colitis, esophagitis, esophageal ulceration, inflammatory bowel disease, nausea, nonspecific gastrointestinal symptoms, pancreatitis, weight loss, xerostomia.
Genitourinary: Nonspecific urogenital findings.
Hematologic: Agranulocytosis (rare), anemia, neutropenia, pyogenic granuloma, thrombocytopenia.
Hepatic: Alkaline phosphatase increased, ALT increased, AST increased, GGTP increased, hepatitis, LDH increased.
Neuromuscular and skeletal: Back pain (29% in pediatric patients), arthralgia, arthritis, bone abnormalities, bone mineral density decreased, calcification of tendons and ligaments, CPK increased, myalgia, premature epiphyseal closure, skeletal hyperostosis, tendonitis, weakness.
Ocular: Cataracts, color vision disorder, conjunctivitis, corneal opacities, dry eyes, eyelid inflammation, keratitis, night vision decreased, optic neuritis, photophobia, visual disturbances.
Otic: Hearing impairment, tinnitus.
Renal: Glomerulonephritis, hematuria, proteinuria, pyuria, vasculitis.
Respiratory: Bronchospasms, epistaxis, respiratory infection, voice alteration, Wegener's granulomatosis.
Miscellaneous: Allergic reactions, anaphylactic reactions, disseminated herpes simplex, diaphoresis, infection, lymphadenopathy.