Orsa Adverse Reactions

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The adverse reactions listed as follows is defined using the following MedDRA convention and system organ class database: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
The most common adverse reactions are phlebitis and pseudo-allergic reactions in connection with too rapid intravenous use of vancomycin.
Blood and the lymphatic system disorders: Rare (≥10,000 to ≤1/1,000): thrombocytopenia, neutropenia, agranulocytosis, eosinophilia.
Immune system disorders: Rare (≥10,000 to ≤1/1,000): anaphylactic reactions, hypersensitivity reactions.
Ear and labyrinth disorders: Uncommon (≥ 1,000 to ≤1/100): transient or permanent loss of hearing.
Rare (≥10,000 to ≤1/1,000): tinnitus, dizziness.
Cardiac disorders: Very rare (≤1/10,000): cardiac arrest.
Vascular disorders: Common (>1/100 to ≤1/10): decrease in blood pressure, thrombophlebitis.
Rare (≥10,000 to ≤1/1,000): vasculitis.
Respiratory, thoracic and mediastinal disorders: Common (>1/100 to ≤1/10): dyspnoea, stridor.
Gastrointestinal disorders: Rare (≥10,000 to ≤1/1,000): nausea.
Very rare (≤1/10,000): pseudomembranous enterocolitis.
Skin and subcutaneous tissue disorders: Common (>1/100 to ≤1/10): exanthema and mucosal inflammation, pruritus, urticaria.
Very rare (≤1/10,000): exfoliative dermatitis, Stevens-Johnson syndrome, Lyell's syndrome, IgA induced bullous dermatitis.
Renal and urinary disorders: Common (>1/100 to ≤1/10): renal insufficiency manifested primarily by increased serum creatinine or serum urea concentrations.
Rare (≥10,000 to ≤1/1,000): interstitial nephritis, acute renal failure.
General disorders and administration site conditions: Common (>1/100 to ≤1/10): redness of the upper body and the face, pain and spasm of the chest and back muscles.
Rare (≥10,000 to ≤1/1,000): drug fever, shivering.
During or shortly after rapid infusion anaphylactic reactions may occur. The reactions abate when administration is stopped, generally between 20 minutes and 2 hours after having stopped administration.
Ototoxicity has primarily been reported in patients given high doses, or concomitant treatment with other ototoxic medicinal products, or with pre-existing reduction in kidney function or hearing.