Oxymetazoline Topical application

In the U.S.

• Rhofade

Available Dosage Forms:

• Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Imidazoline

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• swelling or pain at the application site
• worsening of rosacea pimples

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Data not available

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not assigned. Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal models have revealed evidence of delayed skeletal ossification, increased pup mortality, and decreased pup weight at maternally toxic doses. There are no controlled data in human pregnancy. There is a theoretical association between renal collecting system anomalies and second-trimester exposure in patients using intranasal formulations. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.