VUSION SIDE EFFECTS

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) 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 (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

Gastrointestinal Disorders: vomiting

General Disorders and Administration site Conditions: burning sensation, condition aggravated, inflammation, pain

Injury, Poisoning and Procedural Complications: accidental exposure

Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.