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Locoid Lipocream

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Locoid Lipocream

SIDE EFFECTS

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

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

  Locoid Lipocream
(N=131)
Vehicle
(N=133 )
Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema 1.5% 1.5%
Acne 0.8% 0.0%
Telangiectasia 0.0% 0.8%

Postmarketing Experience

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

DRUG INTERACTIONS

There are no known drug interactions with Locoid Lipocream (hydrocortisone butyrate) .

Read the Locoid Lipocream Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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Locoid Lipocream - User Reviews

Locoid Lipocream User Reviews

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Here is a collection of user reviews for the medication Locoid Lipocream sorted by most helpful. Patient Discussions FAQs

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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