Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following most common adverse reactions (<1%) were local skin reactions: Drying or flaking of the skin;
burning or tingling, erythema;
pigmentation changes;
application site reactions including signs and symptoms of inflammation.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1,056 subjects with recurrent herpes labialis treated 5 times daily for 5 days.
The most common adverse reactions (<1%) were local skin reactions, and occurred in the area of the application site, including: - Drying or flaking of the skin;
burning or tingling following application;
pigmentation changes;
5 WARNINGS AND PRECAUTIONS • Only for topical use for recurrent herpes labialis on the lips and around the mouth.
(5) 5.1 General XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth.
XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.
There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore.
Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.
Like all medications, Xerese can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: