Denavir Side Effects
Please note - some side effects for Denavir 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 Denavir - for the Consumer
Denavir
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 Denavir:
Seek medical attention right away if any of these SEVERE side effects occur when using Denavir:Bad taste in mouth; burning, pain, flushing, or itching at the application site; headache.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
Denavir Side Effects - for the Professional
Denavir
In two double-blind, placebo-controlled trials, 1516 patients were treated with Denavir (penciclovir cream) and 1541 with placebo. The most frequently reported adverse event was headache, which occurred in 5.3% of the patients treated with Denavir and 5.8% of the placebo-treated patients. The rates of reported local adverse reactions are shown in Table 2 below. One or more local adverse reactions were reported by 2.7% of the patients treated with Denavir and 3.9% of placebotreated patients.
Table 2--Local Adverse Reactions Reported in Phase III Trials
| Penciclovir n=1516 % |
Placebo n=1541 % |
|
| Application site reaction | 1.3 | 1.8 |
| Hypesthesia/Local anesthesia | 0.9 | 1.4 |
| Taste pervesion | 0.2 | 0.3 |
| Puritus | 0 | 0.3 |
| Pain | 0 | 0.1 |
| Rash (erthematous) | 0.1 | 0.1 |
| Allergic reaction | 0 | 0.1 |
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 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 cream.
General: Headache, oral/pharyngeal edema, parosmia.
Skin: Application site reactions, aggravated condition, decreased therapeutic response, erythematous rash, local edema, pain, paresthesia, pruritus, skin discoloration and urticaria.
TopSide Effects by Body System
General
Topical penciclovir is generally well tolerated. Incidence of adverse effects in clinical trials was similar to that of placebo.
Nervous system
Nervous system side effects have included headache (5.3%).
Dermatologic
Dermatologic side effects have included application site reactions (1.3%), hypesthesia/local anesthesia (0.9%), and erythematous rash (0.1%). Local edema, pain, paresthesia, pruritus, skin discoloration, urticaria, and aggravation of the condition have also been reported.
Other
Other side effects have included taste perversion (0.2%), and oral/pharyngeal edema, and parosmia.
TopMore resources:
Denavir Topical - Includes detailed dosage instructions.
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