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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 [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]
- Concomitant skin infections [see WARNINGS AND PRECAUTIONS]
- Skin irritation [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience: Adults
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, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Clinical Trials Experience: Pediatrics
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 (hydrocortisone butyrate) clinical trials reflect exposure to Locoid Lipocream twice daily for up to four 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 tables below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream (hydrocortisone butyrate) .
Table 1 : Frequency of adverse reactions in pediatric subjects
with mild to moderate atopic dermatitis
|Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema||1.5%||1.5%|
The following adverse reactions have been identified during post approval use of Locoid Lipocream (hydrocortisone butyrate) . 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.
Skin: Erythema, Rash and Application site irritation.
Read the Locoid Lipocream (hydrocortisone butyrate) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 11/6/2009
Additional Locoid Lipocream Information
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