Famciclovir Side Effects

Brand Names: Famvir

Please note - some side effects for Famciclovir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Famciclovir - for the consumer

Famciclovir

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famciclovir:

Diarrhea; gas; headache; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; confusion; delirium; disorientation; hallucinations; red, swollen, blistered, or peeling skin.

For the professional

Famciclovir

Immunocompetent Patients

The safety of Famciclovir has been evaluated in clinical studies involving 816 Famciclovir-treated patients with herpes zoster (Famciclovir, 250 mg t.i.d. to 750 mg t.i.d.) and 1,197 patients with recurrent genital herpes treated with Famciclovir as suppressive therapy (125 mg q.d. to 250 mg t.i.d.) of which 570 patients received Famciclovir (open-labeled and/or double-blind) for at least 10 months. Table 5 lists selected adverse events.

The following adverse events have been reported during post-approval use of Famciclovir: urticaria, hallucinations and confusion (including delirium, disorientation, confusional state, occurring predominantly in the elderly). Because these adverse events are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. Table 6 lists selected laboratory abnormalities in genital herpes suppression trials.

HIV-Infected Patients

In HIV-infected patients, the most frequently reported adverse events for Famciclovir (500 mg twice daily; n = 150) and acyclovir (400 mg, 5x/day; n = 143), respectively, were headache (16.7% vs. 15.4%), nausea (10.7% vs. 12.6%), diarrhea (6.7% vs. 10.5%), vomiting (4.7% vs. 3.5%), fatigue (4.0% vs. 2.1%), and abdominal pain (3.3% vs. 5.6%).

Postmarketing Experience

The following adverse events have been reported during post-approval use of Famciclovir: urticaria, serious skin reactions (e.g., erythema multiforme), jaundice, thrombocytopenia, hallucinations, dizziness, somnolence and confusion (including delirium, disorientation, confusional state, occurring predominantly in the elderly). Because these adverse events are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

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