"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
Olux-E Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Olux-E (clobetasol propionate foam) is a topical (for the skin) steroid used to treat inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. Common side effects of Olux-E include:
- application site reactions when Olux-E is first applied to the skin (skin rash, burning, itching, redness, irritation, or dryness),
- unusual hair growth,
- "hair bumps" (folliculitis),
- cracking skin,
- thinning or softening of your skin,
- skin rash or irritation around your mouth,
- temporary hair loss,
- spider veins,
- changes in color of treated skin,
- crusting of treated skin, or
- stretch marks.
Tell your doctor if you have severe irritation of any treated skin, or if you show signs of absorbing Olux-E through your skin and have side effects including:
- blurred vision, or seeing halos around lights,
- mood changes,
- sleep problems (insomnia),
- weight gain,
- puffiness in your face,
- muscle weakness, or
- feeling tired.
The dose of Olux-E is to apply a thin layer of foam to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. It is not likely that other drugs you take orally or inject will have an effect on topically applied Olux-E. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, and supplements you use. During pregnancy, Olux-E should be used only when prescribed. It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breastfeeding.
Our Olux-E (clobetasol propionate foam) 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-E 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-E (Clobetasol Propionate Foam)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Olux-E 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 promptly if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration.
Skin infections can become worse when this medication is used. Tell 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 Olux-E (Clobetasol Propionate Foam)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Olux-E FDA Prescribing Information: Side Effects
Clinical Trials Experience
In controlled clinical trials involving 821 subjects exposed to Olux-E (clobetasol propionate foam) Foam and Vehicle Foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with Olux-E (clobetasol propionate foam) Foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender. 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 following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate.
Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.
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.
Read the entire FDA prescribing information for Olux-E (Clobetasol Propionate Foam)
Additional Olux-E Information
Olux-E - User Reviews
Olux-E User Reviews
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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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