sernivo
Pharmaranks rates Sernivo 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sernivo (Betamethasone Dipropionate) is a corticosteroid used to treat Atopic Dermatitis, Facial Dermatoses, Foot Dermatoses, Hand Dermatoses.
Betamethasone Dipropionate · by Primus Pharms
Available as a generic: Betamethasone Dipropionate
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
- Betamethasone Dipropionate
- Drug class
- Corticosteroid
- Form
- Spray/Inhaler
- Strength
- Betamethasone Dipropionate EQ 0.05% BASE/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- atopic dermatitis, facial dermatoses, foot dermatoses
- Manufacturer
- Primus Pharms
- FDA application
- NDA208079
What is Sernivo?
From the FDA label:SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C 28 H 37 FO 7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. Chemical Structure
How to use
Shake well before use. Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended. Discontinue SERNIVO Spray when control is achieved. Do not use if atrophy is present at the treatment site. Do not bandage, cover, or wrap the treated skin area unless directed by a physician. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. SERNIVO Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply to the affected skin areas twice daily. Rub in gently. ( 2 ) Use SERNIVO Spray for up to 4 weeks and not beyond. ( 2 ) Discontinue treatment when control is achieved. ( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side effects
The most common adverse reactions (≥1%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1 . Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N=352) Vehicle Spray b.i.d. (N=180) Application site pruritus 6.0% 9.4% Application site burning and/or stinging 4.5% 10.0% Application site pain 2.3% 3.9% Application site atrophy 1.1% 1.7% Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%)…
Warnings
Important safety information
SERNIVO Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and use in pediatric patients may predispose to HPA axis suppression. Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. ( 5.1 ) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose to HPA axis suppression. ( 5.1 ) Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) 5.1 Effects on Endocrine System SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with SERNIVO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with SERNIVO Spray twice daily for 29 days [ see Clinical Pharmacology ( 12.2 ) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [ see Dosage and Administration ( 2 ) ]. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of SERNIVO Spray is not recommended in pediatric patients [ see Use in Specific Populations ( 8.4 ) ]. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including SERNIVO Spray, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate [ see Adverse Reactions ( 6.2 ) ]. Avoid contact of SERNIVO Spray with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
Who should not take Sernivo
None. None ( 4 )
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Sernivo ranks — best-rated corticosteroid for:
Dosage forms
Spray/Inhaler
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Sernivo treat?
- Sernivo (Betamethasone Dipropionate) may be used to treat atopic dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, inflammation, leg dermatoses, 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 does Sernivo work?
- Sernivo is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Sernivo rated?
- pharmaranks gives Sernivo a composite score of 3.6 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 Sernivo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sernivo. 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 Sernivo?
- Sernivo is marketed by Primus Pharms. You can see Primus Pharms's full profile, rating, and other products on pharmaranks.
- Is Sernivo a brand-name or generic drug?
- Sernivo is a brand-name product with the active ingredient Betamethasone Dipropionate. Lower-cost generic equivalents containing Betamethasone Dipropionate are available — ask your pharmacist.
- Is Sernivo available over the counter?
- No. Sernivo 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 Sernivo come in?
- Sernivo is currently marketed as spray/inhaler, per the FDA's National Drug Code Directory.
- What class of drug is Sernivo?
- Sernivo is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Sernivo FDA-registered?
- Sernivo is on record with the U.S. FDA under application number NDA208079. You can verify this on its official FDA label.
- Has Sernivo been recalled by the FDA?
- Sernivo 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 Sernivo safe?
- There's no single safe-or-not verdict. pharmaranks gives Sernivo a recall-safety score of 72/100, 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 Sernivo?
- Sernivo's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (≥1%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .… 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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sernivo
72/100