"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 "...
Clobex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Clobex (clobetasol propionate) 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. Clobex is available in generic form. Common side effects of Clobex include:
- dryness, and
- redness when first applied to the skin.
These side effects should disappear in a few days as your body adjusts to Clobex. Other side effects of Clobex include:
- skin rash,
- 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,
- crusting of treated skin, or
- stretch marks.
Clobex Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. Do not use more than 26 sprays per application or 52 sprays per day. It is not likely other drugs you take orally or inject will have an effect on topically applied Clobex. But many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Clobex should be used only if prescribed. It is unknown if 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 Clobex (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.
Clobex 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 Clobex (Clobetasol Propionate Spray)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Clobex 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, unusual 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 Clobex (Clobetasol Propionate Spray)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Clobex FDA Prescribing Information: Side Effects
Clinical Trials Experience
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 practice.
In controlled, clinical trials with CLOBEX® Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.
Table 1 : Commonly Occurring Adverse Reactions ( ≥ 1%
|Adverse Reaction||Clobetasol Propionate 0.05% Spray
|System Organ Class|
|General disorders and administration site conditions||50 (42%)||56 (47%)|
|Application site burning||48 (40%)||56 (47%)|
|Application site dryness||2 (2%)||0 (0%)|
|Application site irritation||1 (1%)||0 (0%)|
|Application site pain||1 (1%)||2 (2%)|
|Application site pigmentation changes||1 (1%)||0 (0%)|
|Application site pruritus||4 (3%)||3 (3%)|
|Infections and infestations||17 (14%)||12 (10%)|
|Nasopharyngitis||6 (5%)||3 (3%)|
|Pharyngitis streptococcal||1 (1%)||0 (0%)|
|Upper respiratory tract infection||10 (8%)||2 (2%)|
|Skin and subcutaneous tissue disorders||4 (3%)||2 (2%)|
|Eczema asteatotic||2 (2%)||0 (0%)|
Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
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.
The following adverse reactions have been identified during post-approval use of CLOBEX® Spray, 0.05%.
Read the entire FDA prescribing information for Clobex (Clobetasol Propionate Spray)
Additional Clobex Spray 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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