"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
Olux Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Olux (clobetasol propionate) Foam is a topical (for the skin) steroid used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. Olux Foam is available in generic form. Common side effects of Olux Foam include burning, stinging, itching, irritation, dryness, redness, or skin rash when first applied to the scalp/skin. This should disappear in a few days as your body adjusts to Olux Foam. Other side effects of Olux Foam include dry or cracking skin, thinning or softening of your skin, skin rash or irritation around your mouth, swollen hair follicles, temporary hair loss, spider veins, changes in color of treated skin, blisters, pimples, crusting of treated skin, or stretch marks.
Apply Olux Foam twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. It is not likely that other drugs you take orally or inject will have an effect on topically applied Olux. But many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. Olux should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk when applied to the scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
Our Olux (clobetasol propionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Olux 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.
Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.
Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as:
- blurred vision, or seeing halos around lights;
- mood changes;
- sleep problems (insomnia);
- weight gain, puffiness in your face; or
- muscle weakness, feeling tired.
Less serious side effects may include:
- mild skin rash, itching, burning, or redness;
- dry or cracking skin;
- thinning or softening of your skin;
- skin rash or irritation around your mouth;
- swollen hair follicles;
- temporary hair loss;
- spider veins;
- changes in color of treated skin;
- blisters, pimples, or crusting of treated skin; or
- stretch marks.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Olux (Clobetasol Propionate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Olux 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 (striae), skin thinning/discoloration, excessive hair growth, acne, hair bumps (folliculitis).
Skin infections can become worse when using this medication. Notify your doctor 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Olux (Clobetasol Propionate)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Olux FDA Prescribing Information: Side Effects
In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of OLUX (clobetasol propionate) Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with OLUX (clobetasol propionate) Foam. (See Table 3 below.)
Table 3: Subjects with reversible HPA axis suppression at any time during treatment
|Psoriasis||1 of 9|
|Atopic Dermatitis*||4 of 4|
|*OLUX Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of OLUX Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.|
In a controlled clinical trial (188 subjects) with OLUX (clobetasol propionate) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the OLUX (clobetasol propionate) Foam treated subjects. In two controlled clinical trials (360 subjects) with OLUX (clobetasol propionate) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the OLUX (clobetasol propionate) Foam treated subjects included application site burning (10%), application site dryness ( < 1%), and other application site reactions (4%).
In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).
The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as OLUX (clobetasol propionate) Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.
Read the entire FDA prescribing information for Olux (Clobetasol Propionate)
Additional Olux Information
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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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