Denavir

What Is Denavir?

Denavir (penciclovir cream) is an antiviral medication used topically (on the skin) for the treatment of recurrent cold sores.

What Are Side Effects of Denavir?

Common side effects of Denavir include:

• application site reactions (such as redness, burning, stinging, numbness, rash, pain, itching, skin discoloration, or hives),
• changes in the sense of taste,
• headache, or
• swollen mouth or throat.

A very serious allergic reaction to Denavir is rare. Seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.

Dosage for Denavir

A dose of Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear). Do not use other topical medications to treat the same area at the same time as Denavir topical, unless directed by your doctor.

What Drugs, Substances, or Supplements Interact with Denavir?

No other medicines have been reported to interact with Denavir topical. Tell your doctor all prescription or over-the-counter medications you use.

Denavir During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Denavir. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Denavir (penciclovir cream) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Denavir Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe skin redness, itching, rash, or pain after applying this medicine.

Common side effects may include:

• numbness or tingling where the medicine was applied;
• headache; or
• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Denavir (Penciclovir)

 

Denavir Professional Information

SIDE EFFECTS

Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In two double-blind, placebo-controlled trials, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1.

Table 1 : Local Adverse Reactions Reported in Phase III Trials

	Penciclovir n=1516 %	Placebo N=1541 %
Application site reaction	1	2
Hypesthesia/Local anesthesia	< 1	< 1
Taste perversion	< 1	< 1
Rash (erythematous)	< 1	< 1

Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of DENAVIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following events have been identified from worldwide post-marketing use of DENAVIR in treatment of recurrent herpes labialis (cold sores) in adults. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to DENAVIR.

General: Headache, oral/pharyngeal edema, parosmia.

Skin: Aggravated condition, decreased therapeutic response, local edema, pain, paresthesia, pruritus, skin discoloration, and urticaria.

Read the entire FDA prescribing information for Denavir (Penciclovir)