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.
ADVERSE REACTIONS In clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts.
The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period.
Severe reactions were most frequent within the first 2 weeks of treatment.
Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%);
less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.
The most common systemic adverse event reported during the clinical studies was headache (7%).
WARNINGS Correct diagnosis of the lesions to be treated is essential.
See the Diagnosis subsection of the INDICATIONS AND USAGE section.
Condylox Gel 0.5% is intended for cutaneous use only.
Avoid contact with the eyes.
If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.
Like all medications, Condylox 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: