ADVERSE REACTIONS Frequently reported adverse events in clinical trials of VALTREX in healthy patients are listed in Tables 4 and 5.  Laboratory abnormalities reported in clinical trials of VALTREX in otherwise healthy patients are listed in Table 6. Table 6. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Study Populations Herpes Zoster Genital Herpes Treatment Genital Herpes Suppression Laboratory Abnormality VALTREX 1 gram t.i.d. Place-bo VALTREX 1 gram b.i.d. VALTREX 500 mg b.i.d. Place-bo VALTREX 1 gram q.d. VALTREX 500 mg q.d. Place-bo Hemoglobin (<0.8 x LLN) 0.8% 0% 0.3% 0.2% 0% 0% 0.8% 0.8% White blood cells (<0.75 x LLN) 1.3% 0.6% 0.7% 0.6% 0.2% 0.7% 0.8% 1.5% Platelet count (<100,000/mm 3 ) 1.0% 1.2% 0.3% 0.1% 0.7% 0.4% 1.1% 1.5% AST (SGOT) (>2 x ULN) 1.0% 0% 1.0% * 0.5% 4.1% 3.8% 3.0% Serum creatinine (>1.5 x ULN) 0.2% 0% 0.7% 0% 0% 0% 0% 0% *Data were not collected prospectively. LLN = Lower limit of normal. ULN = Upper limit of normal. Suppression of Genital Herpes in HIV-Infected Patients: In HIV-infected patients, frequently reported adverse events for VALTREX (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13% vs. 8%), fatigue (8% vs. 5%), and rash (8% vs. 1%). Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir subjects versus placebo included elevated alkaline phosphatase (4% vs. 2%), elevated ALT (14% vs. 10%), elevated AST (16% vs. 11%), decreased neutrophil counts (18% vs. 10%), and decreased platelet counts (3% vs. 0%). | ||||
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