Ultravate

What Is Ultravate?

Ultravate (halobetasol propionate) Ointment and Cream, 0.05% is a corticosteroid prescribed for the for the relief of inflammation and itching due to a variety of skin conditions such as dermatitis, eczema, allergies, and rash. Ultravate is available in generic form.

What Are Side Effects of Ultravate?

Common side effects for Ultravate Cream include:

• application site skin reactions (stinging, burning, itching, dryness, or redness),
• skin rash,
• thinning or softening of your skin,
• skin rash or irritation around your mouth,
• swollen hair follicles,
• spider veins,
• numbness or tingling,
• changes in color of treated skin,
• blisters,
• pimples,
• crusting of treated skin, or
• stretch marks.

Skin infections can become worse when using Ultravate Cream. Tell your doctor if redness, swelling or irritation does not improve.

Dosage for Ultravate?

Apply a thin layer dose of Ultravate to the affected skin twice daily for up to two weeks. Rub in gently.

What Drugs, Substances, or Supplements Interact with Ultravate?

Ultravate may interact with other drugs. Tell your doctor all medications and supplements you use.

Ultravate During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Ultravate; it is unknown if it will harm a fetus. It is unknown if Ultravate topical passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Ultravate (halobetasol propionate) Ointment and Cream, 0.05% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Ultravate 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 (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common side effects may include:

• burning, stinging, itching, or dryness of treated skin;
• pain where the foam was applied;
• redness or crusting around your hair follicles;
• stretch marks;
• spider veins;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 Ultravate (Halobetasol Propionate)

 

Ultravate 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.

During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week).

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.

Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks

	ULTRAVATE Lotion (N= 277)	Vehicle Lotion (N= 259)
Adverse Reaction	%	%
Telangiectasia	1%	0%
Application site atrophy	1%	< 1%
Headache	1%	< 1%

Less common adverse reactions (incidence less than 1% but greater than 0.1%) that occurred in subjects treated with ULTRAVATE lotion included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.

Read the entire FDA prescribing information for Ultravate (Halobetasol Propionate)