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Denavir

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Since 2009, the Food and Drug Administratio"...

Denavir

Denavir

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 Denavir (penciclovir) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies have been performed with DENAVIR. Due to minimal systemic absorption of DENAVIR, systemic drug interactions are unlikely.

Last reviewed on RxList: 9/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Denavir - User Reviews

Denavir User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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