Zovirax Side Effects

Generic name: acyclovir

Note: This document contains side effect information about acyclovir. Some of the dosage forms listed on this page may not apply to the brand name Zovirax.

Some side effects of Zovirax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to acyclovir: oral capsule, oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking acyclovir (the active ingredient contained in Zovirax) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• pain in your lower back;

• urinating less than usual or not at all;

• easy bruising or bleeding; or

• unusual weakness.

Less serious side effects of acyclovir may include:

• nausea, vomiting, diarrhea, loss of appetite, stomach pain;

• headache, feeling light-headed; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to acyclovir: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects have been the most frequently reported side effects, and include nausea, vomiting, abdominal pain, and diarrhea.

Nausea and vomiting have been reported with oral and intravenous administration, and have preceded neurotoxicity and nephrotoxicity. Gagging and anorexia have also been reported.

Renal

Renal side effects have included renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated serum creatinine, and hematuria. Renal effects generally are transient and resolve over several days following discontinuation of therapy; however fatal renal failure has occurred. Renal damage is most commonly due to crystallization of the drug in the renal tubules. Acute tubular necrosis and interstitial nephritis have also been reported.

Transient renal dysfunction has been reported with both oral and intravenous acyclovir therapy. Crystallization of the drug in renal tubules is thought to be the mechanism for the development of renal dysfunction, based on findings of crystalluria in several case reports and at least one prospective study.

Elderly or renally impaired patients are at greater risk for developing neurotoxicity and further deterioration in renal function.

Nervous system

Nervous system side effects have included aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, delusions, disorientation, dizziness, EEG changes, abnormal cerebrospinal fluid findings, encephalopathy, focal neurological signs, hallucinations, headache, insomnia, irritability, lightheadedness, major depression, mania, myoclonus, obtundation, paresthesia, psychosis, seizure, somnolence, tremors, and Cotard's syndrome. Neurotoxicity generally develops early in acyclovir (the active ingredient contained in Zovirax) treatment and has most commonly been reported in patients with renal failure, the elderly, and in patients following bone marrow transplant. It is thought to be associated with high serum concentrations of acyclovir. Guillain Barre syndrome has been reported in at least one patient receiving acyclovir prophylaxis following allogeneic marrow transplantation.

Acyclovir neurotoxicity is almost exclusively seen in patients with renal failure. These patients may have longstanding chronic renal failure or acute failure associated with acyclovir. Although more commonly seen with intravenous administration of larger doses, neurotoxicity has also been reported in patients receiving oral doses of acyclovir. Following discontinuation of acyclovir, mental status recovers within about a week. Several patients with chronic renal failure exhibiting neurotoxicity improved dramatically following hemodialysis. In one study of renal transplant patients receiving oral acyclovir therapy, one patient developed neurotoxicity, manifested as disorientation, confusion and myoclonus. The symptoms responded to a decrease in dosage. Three other case reports have also described neurologic symptoms, including visual hallucinations, delusions, mania, tremors, myoclonus and EEG changes, which improved following discontinuation of intravenous acyclovir. Rechallenge in one case using a lower dosage resulted in no sequelae.

Local

Local adverse effects associated with intravenous administration of acyclovir (the active ingredient contained in Zovirax) have included inflammation or phlebitis at the injection site. Phlebitis is more common when concentrated solutions (greater than 7 mg/mL) are administered. Skin eruptions have been reported at venipuncture sites and tissue necrosis has occurred after infiltration into extravascular tissues.

Cardiovascular

Cardiovascular side effects have included hypotension.

Dermatologic

Dermatologic side effects have included alopecia, erythema multiforme, hives, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria.

Hematologic

Hematologic and lymphatic side effects have included anemia, disseminated intravascular coagulation, hemolysis, leukocytoclastic vasculitis, leukocytosis, leukopenia, lymphadenopathy, neutropenia, neutrophilia, thrombocytosis, thrombocytopenia, and pancytopenia.

Hepatic

Hepatic side effects have included elevated liver function tests, hepatitis, hyperbilirubinemia, and jaundice.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis.

Ocular

Ocular side effects have included visual abnormalities.

Musculoskeletal

Musculoskeletal side effects reported have included myalgia and dysarthria.

Other

Other side effects have included angioedema, fever, malaise, pain, fatigue, peripheral edema, and increased lactate dehydrogenase.

Genitourinary

Genitourinary side effects have included crystalluria.

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