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warnings
Warnings Tissue damage: Intramuscular hydroxyzine hydrochloride may result in severe injection site reactions (including extensive tissue damage, necrosis and gangrene) requiring surgical intervention (including debridement, skin grafting and amputation).
Adverse Reaction Therapeutic doses of hydroxyzine seldom produce impairment of mental alertness. However, drowsiness may occur; if so, it is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered in the recommended doses for over four years of uninterrupted therapy. The absence of adverse effects has been further demonstrated in experimental studies in which excessively high doses were administered. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered. Hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) in post marketing reports.