Vivocin Side Effects



Gland Pharma


Full Prescribing Info
Side Effects
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: 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: thrombocytopenia, neutropenia, agranulocytosis, eosinophilia.
Immune system disorders: Rare: anaphylactic reactions, hypersensitivity reactions.
Ear and labyrinth disorders: Uncommon: transient or permanent loss of hearing. Rare: tinnitus, dizziness.
Cardiac disorders: Very rare: cardiac arrest.
Vascular disorders: Common: decrease in blood pressure, thrombophlebitis. Rare: vasculitis.
Respiratory, thoracic and medistinal disorders: Common: dyspnoea, stridor.
Gastrointestinal disorders: Rare: nausea. Very rare: pseudomembranous enterocolitis.
Skin and subcutaneous tissue disorders: Common: exanthema and mucosal inflammation, pruritus, urticaria. Very rare: exfoliative dermatitis, Stevens-Johnson syndrome, Lyell's syndrome, IgA induced bullous dermatitis.
Renal and urinary disorders: Common: renal insufficiency manifested primarily by increased serum creatinine or serum urea concentrations. Rare: interstitial nephritis, acute renal failure.
General disorders and administration site conditions: Common: redness of the upper body and the face, pain and spasm of the chest and back muscles. Rare: 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.
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