Clobex

What Is Clobex?

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.

What Are Side Effects of Clobex?

Common side effects of Clobex include:

• burning,
• stinging,
• itching,
• irritation,
• 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,
• blisters,
• pimples,
• crusting of treated skin, or
• stretch marks.

Dosage for Clobex

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.

What Drugs, Substances, or Supplements Interact with Clobex?

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.

Clobex During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Clobex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine through your skin--weight gain in your face and shoulders, slow wound healing, skin discoloration, thinning skin, increased body hair, tiredness, mood changes, menstrual changes, sexual changes.

Common side effects may include:

• burning, itching, swelling, or irritation of treated skin;
• dry or cracking skin;
• redness or crusting around your hair follicles;
• spider veins;
• stretch marks, thinning skin;
• rash or hives;
• acne; or
• temporary hair loss.

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 Clobex (Clobetasol Propionate Spray)

 

Clobex Professional 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% Incidence)

Adverse Reaction	Clobetasol Propionate 0.05% Spray (N=120)	Vehicle Spray (N=120)
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 glycosuria in some patients.

Postmarketing Experience

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%.

Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.

Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.

Read the entire FDA prescribing information for Clobex (Clobetasol Propionate Spray)