Because ulcerated genital lesions are characteristically tender and sensitive to any contact or manipulation, patients may experience discomfort upon application of ointment. In the controlled trials, mild pain (including transient burning and stinging) was reported by 103 (28.3%) of 364 patients treated with acyclovir and by 115 (31.1%) of 370 patients treated with placebo; treatment was discontinued in 2 of these patients. Other local reactions among acyclovir-treated patients included pruritus in 15 (4.1%), rash in 1 (0.3%) and vulvitis in 1 (0.3%). Among the placebo-treated patients, pruritus was reported by 17 (4.6%) and rash by 1 (0.3%).

In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.

Observed During Clinical Practice

Based on clinical practice experience in patients treated with acyclovir ointment in the U.S., spontaneously reported adverse reactions are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as proof of the underlying disease process. Voluntary reports of adverse events which have been received since market introduction include:

General: edema and/or pain at the application site

Skin: pruritus, rash

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%.

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