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Prudoxin 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.
Prudoxin FDA Prescribing Information: Side Effects
Controlled Clinical Trials
Systemic Adverse Effects: In controlled clinical trials of patients treated with Doxepin HCl Cream 5%, the most common systemic adverse effect reported was drowsiness. Drowsiness occurred in 22% of patients treated with Doxepin HCl Cream 5% (and 2% of patients treated with placebo cream) and resulted in the premature discontinuation of the drug in approximately 5% of patients treated.
Local Site Adverse Effects: In controlled clinical trials of patients treated with Doxepin HCl Cream 5%, the most common local site adverse effect reported was burning and/or stinging at the site of application. These occurred in approximately 21% of these patients. 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 Doxepin HCl Cream 5% withdrew from the study because of the burning and/or stinging.
Other local site adverse effects reported in approximately 1 to 10% of these patients included: Pruritus exacerbation, eczema exacerbation, dryness and tightness to skin, paresthesias, and edema.
Other local site adverse effects reported in less than 1% of these patients included: Irritation, tingling, scaling, and cracking.
Post Marketing Experience
Some cases of allergic contact dermatitis have been reported in patients using Doxepin HCl 5% cream.
Read the entire FDA prescribing information for Prudoxin (Doxepin) »
Additional Prudoxin 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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