Medical Editor: John P. Cunha, DO, FACOEP
What Is Sernivo?
What Are Side Effects of Sernivo?
Common side effects of Sernivo include application site reactions include:
- pain, and
- thinning skin
Dosage for Sernivo
Apply a dose of Sernivo Spray 0.05% to the affected skin areas twice daily. Rub in gently. Use Sernivo Spray for up to 4 weeks and not beyond.
What Drugs, Substances, or Supplements Interact with Sernivo?
Sernivo may interact with other drugs. Tell your doctor all medications and supplements you use.
Sernivo During Pregnancy and Breastfeeding
During pregnancy, Sernivo should be used only if prescribed. Corticosteroids pass into breast milk when taken orally and can have undesirable effects on a nursing infant. It is unknown if topically applied corticosteroids such as Sernivo pass into breast milk. Consult your doctor before breastfeeding.
Our Sernivo (betamethasone dipropionate) Spray, 0.05% 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.
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.
|Vehicle Spray b.i.d
|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%) in subjects treated with SERNIVO spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.
Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.
Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.
Read the entire FDA prescribing information for Sernivo (Betamethasone Dipropionate Spray, 0.05%)