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Cold Sores (Herpes Labialis): In clinical studies for the treatment of cold sores, the adverse events reported by patients receiving VALTREX (n = 609) or placebo (n = 609) included headache (VALTREX 14%, placebo 10%) and dizziness (VALTREX 2%, placebo 1%). The frequencies of abnormal ALT (>2 x ULN) were 1.8% for patients receiving VALTREX compared with 0.8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase, and serum creatinine) occurred with similar frequencies in the 2 groups. Observed During Clinical Practice: Text Continues Below
The following events have been identified during post-approval use of VALTREX in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, causal connection to VALTREX, or a combination of these factors. General Facial edema, hypertension, tachycardia. Allergic Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria. CNS Symptoms Aggressive behavior; agitation; ataxia; coma; confusion; decreased consciousness; dysarthria; encephalopathy; mania; and psychosis, including auditory and visual hallucinations; seizures, tremors (see PRECAUTIONS). Eye Visual abnormalities. Gastrointestinal Diarrhea. Hepatobiliary Tract and Pancreas Liver enzyme abnormalities, hepatitis. Renal Elevated creatinine, renal failure. Hematologic Thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis, TTP/HUS. Skin: Erythema multiforme, rashes including photosensitivity, alopecia. Renal Impairment Renal failure and CNS symptoms have been reported in patients with renal impairment who received VALTREX or acyclovir at greater than the recommended dose. Dose reduction is recommended in this patient population (see DOSAGE AND ADMINISTRATION). Page: << Prev | 1 | 2
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