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  • Generic Name: acyclovir for injection
  • Brand Name: Zovirax Injection
  • Drug Class: Antivirals, Other
Last updated on MDtodate: 10/03/2022


Adverse Effects Derived from Clinical Trials

The adverse reactions listed have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received ZOVIRAX at ~5 mg/kg (250 mg/m2) 3times daily and approximately 300 patients who received 10 mg/kg (500 mg/m2) 3 times daily.

The following convention has been used for the classification of undesirable effects in terms of frequency: Very common ≥ 1/10, common ≥ 1/100 and < 1/10, uncommon ≥ 1/1 000 and < 1/100, rare ≥ 1/10 000 and < 1/1 000, very rare < 1/10 000.

Blood and Lymphatic System Disorders

Uncommon: decreases in haematological indices (anaemia, thrombocytopenia, leucopenia).

Vascular Disorders

Common: phlebitis.

Gastrointestinal Disorders

Common: nausea, vomiting.

Hepatobiliary Disorders

Common: reversible increases in liver-related enzymes.

Skin and Subcutaneous Tissue Disorders

Common: rashes (including photosensitivity), urticaria, pruritus, fevers.

Renal and Urinary Disorders

Common: increases in blood urea and creatinine levels. Rapid increases in blood urea and creatinine levels are believed to be related to peak plasma levels and the state of hydration of the patient. To avoid this effect, ZOVIRAX should not be given as an intravenous bolus injection, but by slow infusion over a one hour period.

Adverse Effects Derived from Post-Marketing Data

The following events have been identified during post-approval use of ZOVIRAX from spontaneous reports. As these are reported from a population of unknown size, precise estimates of frequency cannot be made.

Immune system disorders: Anaphylaxis.

Psychiatric and nervous system disorders: Headache, dizziness, agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.

The above events are generally reversible and usually reported in patients with renal impairment, or with other predisposing factors (see WARNINGS AND SPECIAL PRECAUTIONS).

Respiratory, thoracic and mediastinal disorders: Dyspnoea.

Gastrointestinal disorders: Diarrhoea, abdominal pain.

Hepatobiliary disorders: Reversible increases in bilirubin, hepatitis, jaundice.

Skin and subcutaneous tissue disorders: Angioedema, accelerated diffuse hair loss. The relationship of accelerated diffuse hair loss to ZOVIRAX therapy is uncertain.

Renal and urinary disorders: Renal impairment, acute renal failure.

Adequate hydration of the patient should be maintained. Renal impairment usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of ZOVIRAX. Progression to acute renal failure, may occur.

General disorders and administration site conditions: Fatigue, fever, local inflammatory reactions.

Severe local inflammatory reactions sometimes leading to ulceration have occurred when ZOVIRAX IV has been inadvertently infused into extravascular tissues.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of acyclovir cream. Because they arereported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination oftheir seriousness, frequency of reporting, or potential causal connection to acyclovir cream.

General: Angioedema, anaphylaxis.

Skin: Contact dermatitis, eczema.



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