Denavir
Temporary Tattoos May Put You at Risk »
"Spring break is on the way, or maybe summer vacation. Time to pack your swim suit, hit the beach, and perhaps indulge in a little harmless fun. What about getting a temporary tattoo to mark the occasion? Who could it hurt to get a temporary tatto"...
Denavir
SIDE EFFECTS
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 (penciclovir) 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 (penciclovir) and 3.9% of placebo-treated 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 perversion | 0.2 | 0.3 |
| Pruritus | 0.0 | 0.3 |
| Pain | 0.0 | 0.1 |
| Rash (erythematous) | 0.1 | 0.1 |
| Allergic reaction | 0.0 | 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 (penciclovir) 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 (penciclovir) 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.
Read the Denavir (penciclovir) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
No information provided.
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Denavir Information
Denavir - User Reviews
Denavir User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Denavir sorted by most helpful.
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.
Women's Health
Find out what women really need.
Updated & New
