Xerese
FDA Issues Proposal to Increase Consumer Awareness of Tanning Bed Risks »
"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
Accordin"...
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Xerese
Xerese Side Effects Center
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xerese FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Overall Adverse Reaction Profile
The safety data derived from XERESE (acyclovir and hydrocortisone cream) clinical studies reflect exposure to XERESE (acyclovir and hydrocortisone cream) in 1002 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The majority of the adverse reactions were local skin reactions and occurred in the area of the application site.
Adverse Reactions in Clinical Studies
Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.
The majority of the adverse reactions were local and occurred in the area of the application site.
Skin and Subcutaneous Tissue Disorders
The following most common adverse reactions ( < 1%) were local skin reactions, and occurred in the area of the application site:
- Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.
Contact dermatitis following application has been observed when applied under occlusion in dermal safety studies. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.
A study enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE (acyclovir and hydrocortisone cream) using repeat insult patch testing methodology. Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE (acyclovir and hydrocortisone cream) base were identified. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.
Dermal tolerance was assessed in a 21-day cumulative irritation study in 36 healthy subjects. XERESE (acyclovir and hydrocortisone cream) , its cream base and Zovirax® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semi-occlusive conditions.
Photoallergic potential and phototoxicity were assessed in two studies in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE (acyclovir and hydrocortisone cream) .
Read the entire FDA prescribing information for Xerese (Acyclovir and Hydrocortisone Cream) »
Additional Xerese Information
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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