rhofade
Pharmaranks rates Rhofade 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Rhofade (Oxymetazoline Hydrochloride) is a vasoconstrictor used to treat Common Cold, Conjunctivitis, Rhinitis, Sinusitis.
Oxymetazoline Hydrochloride · by Mayne Pharma
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Oxymetazoline Hydrochloride
- Drug class
- Vasoconstrictor
- Form
- Topical
- Strength
- Oxymetazoline Hydrochloride 1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- common cold, conjunctivitis, rhinitis
- Manufacturer
- Mayne Pharma
- FDA application
- NDA208552
What is Rhofade?
From the FDA label:Oxymetazoline Hydrochloride Cream, 1% contains oxymetazoline hydrochloride, an alpha 1A adrenoceptor agonist. Oxymetazoline Hydrochloride Cream is a white to off-white cream. It has a chemical name of 3-[(4,5-Dihydro1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)- 2,4-dimethyl-phenol hydrochloride and a molecular weight of 296.8. It is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is C 16 H 25 ClN 2 O and its structural formula is: Each gram of Oxymetazoline Hydrochloride Cream, 1% contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. The cream contains the following inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water. Chemical Structure
How to use
For topical use only. Oxymetazoline Hydrochloride Cream is not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount of Oxymetazoline Hydrochloride Cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying Oxymetazoline Hydrochloride Cream. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Prime pump bottle before initial use and discard product from first three pumps. ( 2 ) Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. ( 2 ) Wash hands after application. ( 2 )
Side effects
Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 Oxymetazoline Hydrochloride Cream 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 Oxymetazoline Hydrochloride Cream 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 Oxymetazoline Hydrochloride Cream 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 Oxymetazoline HCl Cream (N = 489)…
Warnings
Important safety information
Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens. ( 5.1 ) Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. ( 5.2 ) Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. ( 5.3 ) 5.1 Potential Impacts on Cardiovascular Disease Alpha-adrenergic agonists may impact blood pressure. Oxymetazoline Hydrochloride Cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens. 5.2 Potentiation of Vascular Insufficiency Oxymetazoline Hydrochloride Cream should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangitis obliterans, scleroderma, or Sjögren's syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop. 5.3 Risk of Angle Closure Glaucoma Oxymetazoline Hydrochloride Cream may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
Who should not take Rhofade
None. None. ( 4 )
Overdose — what happens if you take too much
Oxymetazoline Hydrochloride Cream is not for oral use. If oral ingestion occurs, seek medical advice. Monitor patient closely and administer appropriate supportive measures as necessary. Accidental ingestion of topical solutions (nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma. Keep Oxymetazoline Hydrochloride Cream out of reach of children.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Anti-hypertensives/Cardiac Glycosides Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha 1 adrenergic receptor antagonists such as in the treatment of cardiovascular disease, benign prostatic hypertrophy, or Raynaud's disease. 7.2 Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Drug class
May treat (source: NIH RxClass)
See how Rhofade ranks — best-rated vasoconstrictor for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Rhofade treat?
- Rhofade (Oxymetazoline Hydrochloride) may be used to treat common cold, conjunctivitis, rhinitis, sinusitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Rhofade rated?
- pharmaranks gives Rhofade a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Rhofade?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rhofade. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rhofade?
- Rhofade is marketed by Mayne Pharma. You can see Mayne Pharma's full profile, rating, and other products on pharmaranks.
- Is Rhofade a brand-name or generic drug?
- Rhofade is a brand-name product with the active ingredient Oxymetazoline Hydrochloride.
- Is Rhofade available over the counter?
- No. Rhofade is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rhofade come in?
- Rhofade is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Rhofade?
- Rhofade is classified as vasoconstrictor, per the FDA's Established Pharmacologic Class.
- Is Rhofade FDA-registered?
- Rhofade is on record with the U.S. FDA under application number NDA208552. You can verify this on its official FDA label.
- Has Rhofade been recalled by the FDA?
- Rhofade has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Rhofade safe?
- There's no single safe-or-not verdict. pharmaranks gives Rhofade a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Rhofade?
- Rhofade's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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rhofade
70/100