Vusion Side Effects

Please note - some side effects for Vusion 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 Vusion - for the Consumer

Vusion

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Vusion. Seek medical attention right away if any of these SEVERE side effects occur when using Vusion:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation.

Vusion Side Effects - for the Professional

Vusion

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Vusion Ointment group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Vusion were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

The potential for dermal toxicity of Vusion Ointment formulation was investigated in healthy adult volunteers in four topical safety studies. These studies were conducted to assess the potential for contact phototoxicity, photoallergy, sensitization, and cumulative irritation potential. Phototesting was conducted with UV-A only. Results indicated that Vusion Ointment did not induce a contact dermal phototoxic response, contact dermal photoallergic response, or contact dermal sensitization in adult subjects. In addition, Vusion Ointment did not show any evidence of cumulative irritation potential in adult subjects.

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