Rhofade

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 4/26/2022
Rhofade Side Effects Center

What Is Rhofade?

Rhofade (oxymetazoline hydrochloride) cream, for topical use is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

What Are Side Effects of Rhofade?

Common side effects of Rhofade include:

  • application site reactions (swelling, itching, redness, and pain), and
  • worsening inflammatory lesions of rosacea.

Dosage for Rhofade

Apply a pea-sized dose of Rhofade once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands after application.

What Drugs, Substances, or Supplements Interact with Rhofade?

Rhofade may interact with beta-blockers, anti-hypertensives, cardiac glycosides, other alpha1 adrenergic receptor antagonists, and MAO inhibitors. Tell your doctor all medications and supplements you use.

Rhofade During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Rhofade; it is unknown how it will affect a fetus. It is unknown if Rhofade passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Rhofade (oxymetazoline hydrochloride) Cream, For Topical Use 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.

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow
Rhofade 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.

Stop using this medicine and call your doctor at once if you have:

  • worsening of your rosacea symptoms;
  • numbness, tingling, cold feeling in your hands or feet;
  • pale or purple appearance in your fingers or toes; or
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights.

Common side effects may include:

  • skin redness or itching;
  • pain; or
  • other skin reactions.

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 Rhofade (Oxymetazoline Hydrochloride)

QUESTION

Rosacea usually first appears on the ________. See Answer
Rhofade Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under 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.

A total of 489 subjects with persistent facial erythema associated with rosacea were treated with RHOFADE once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with RHOFADE once daily for up to one year in a long-term (open-label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with RHOFADE through 4 weeks of treatment are presented in Table 1 below.

Table 1: Adverse Reactions Reported by ≥ 1% of Subjects through 4 Weeks of Treatment in Controlled Clinical Trials

Adverse Reaction Pooled Controlled Clinical Trials
RHOFADE Cream
(N = 489)
Vehicle Cream
(N = 483)
Application site dermatitis 9 (2%) 0
Worsening inflammatory lesions of rosacea 7 (1%) 1 (<1%)
Application site pruritus 5 (1%) 4 (1%)
Application site erythema 5 (1%) 2 (<1%)
Application site pain 4 (1%) 1 (<1%)

In the long-term (open-label) clinical trial, the rates of adverse reactions over a one-year treatment period were as follows: worsening inflammatory lesions of rosacea (3%), application site dermatitis (3%), application site pruritis (2%), application site pain (2%), and application site erythema (2%). Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea.

Read the entire FDA prescribing information for Rhofade (Oxymetazoline Hydrochloride)

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© Rhofade Patient Information is supplied by Cerner Multum, Inc. and Rhofade Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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