Locoid Lipocream
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Locoid Lipocream
Locoid Lipocream Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Locoid Lipocream in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using hydrocortisone topical and call your doctor at once if you have any of these serious side effects:
- blurred vision, or seeing halos around lights;
- uneven heartbeats;
- sleep problems (insomnia);
- weight gain, puffiness in your face; or
- feeling tired.
Less serious side effects may include:
- skin redness, burning, itching, or peeling;
- thinning of your skin;
- blistering skin; or
- stretch marks.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Locoid Lipocream (Hydrocortisone Butyrate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Locoid Lipocream Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).
Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.
Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Locoid Lipocream (Hydrocortisone Butyrate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Locoid Lipocream FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 [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
| 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 entire FDA prescribing information for Locoid Lipocream (Hydrocortisone Butyrate) »
Additional Locoid Lipocream Information
Locoid Lipocream - User Reviews
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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