LOCOID LIPOCREAM SIDE EFFECTS

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• HPA-axis suppression. This has been observed in pediatric subjects using Locoid Lipocream
• Concomitant skin infections
• Allergic contact dermatitis

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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.

The safety data derived from Locoid Lipocream clinical trials reflect exposure to Locoid Lipocream twice daily for up to 4 weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis. Adverse reactions shown in the table below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream.

Table 1: Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis

Postmarketing Experience

Because adverse 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.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

SRC: NLM .