Zonalon Side Effects

Please note - some side effects for Zonalon 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 Zonalon - for the consumer

Zonalon Cream

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 Zonalon Cream:

Abnormal skin sensations; burning and stinging at the application site; changes in emotions; confusion; dizziness; drowsiness; dry and tight skin; dry mouth and lips; fatigue; headache; itching; swelling; taste changes; thirst.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; rapid or pounding heartbeat; severe burning and stinging at the application site.

For the professional

Zonalon

Controlled Clinical Trials

In controlled clinical trials of patients treated with Zonalon® Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon® Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with Zonalon® Cream in controlled clinical trials.

In controlled clinical trials of patients treated with Zonalon® Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with Zonalon® Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with Zonalon® Cream withdrew from the study because of the burning and/or stinging.

The table below presents the adverse events reported at an incidence of ≥ 1% in either Zonalon® or vehicle cream treatment groups during the trials:

Adverse events occurring in 0.5% to < 1.0% of Zonalon® Cream treated patients in the controlled clinical trials included: nervousness/anxiety, tongue numbness, fever, and nausea.

Post-Marketing Experience

Twenty-six cases of allergic contact dermatitis have been reported in patients using Zonalon® Cream, twenty of which were documented by positive patch test to doxepin 5% cream.

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