Herpes Simplex
Short-Term Administration: The most frequent adverse events reported
during clinical trials of treatment of genital herpes with ZOVIRAX (acyclovir) 200 mg administered
orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in
8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of
287 (0.7%) patients who received placebo.
Long-Term Administration: The most frequent adverse events reported
in a clinical trial for the prevention of recurrences with continuous administration
of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated
with ZOVIRAX (acyclovir) were nausea (4.8%) and diarrhea (2.4%). The 589 control patients
receiving intermittent treatment of recurrences with ZOVIRAX (acyclovir) for 1 year reported
diarrhea (2.7%), nausea (2.4%), and headache (2.2%).
Herpes Zoster
The most frequent adverse event reported during 3 clinical trials of treatment
of herpes zoster (shingles) with 800 mg of oral ZOVIRAX (acyclovir) 5 times daily for 7
to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported
malaise (11.1%).
Chickenpox
The most frequent adverse event reported during 3 clinical trials of treatment
of chickenpox with oral ZOVIRAX (acyclovir) at doses of 10 to 20 mg/kg 4 times daily for
5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea
(3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).
Observed During Clinical Practice: In addition to adverse events reported
from clinical trials, the following events have been identified during post-approval
use of ZOVIRAX (acyclovir) . 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, potential
causal connection to ZOVIRAX (acyclovir) , or a combination of these factors.
General: Anaphylaxis, angioedema, fever, headache, pain, peripheral
edema.
Nervous: Aggressive behavior, agitation, ataxia, coma, confusion,
decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations,
paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be
marked, particularly in older adults or in patients with renal impairment (see
PRECAUTIONS).
Digestive: Diarrhea, gastrointestinal distress, nausea.
Hematologic and Lymphatic:Anemia, leukocytoclastic vasculitis,
leukopenia, lymphadenopathy, thrombocytopenia.
Hepatobiliary Tract and Pancreas: Elevated liver function tests,
hepatitis, hyperbilirubinemia, jaundice.
Musculoskeletal: Myalgia.
Skin:Alopecia, erythema multiforme, photosensitive rash, pruritus,
rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Special Senses: Visual abnormalities
Urogenital: Renal failure, renal pain (may be associated with
renal failure), elevated blood urea nitrogen, elevated creatinine, hematuria
(see WARNINGS).