What the label lists and what reports show
Betamethasone side effects
Betamethasone's FDA label lists its adverse reactions in its own words. FAERS holds 10,812 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (948 reports).
- Generic listed
Check it at the source: the betamethasone FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of betamethasone dipropionate cream (augmented)?Betamethasone dipropionate cream (augmented) may cause serious side effects, including: • Betamethasone dipropionate cream (augmented) can pass through your skin. Too much betamethasone dipropionate cream (augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. • Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol. • High blood sugar (hyperglycemia). • Effects on growth and weight in children. • Vision problems. Topical corticosteroids including betamethasone dipropionate cream (augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with betamethasone dipropionate cream (augmented). […]
Source: FDA drug label (Betamethasone Dipropionate), Padagis Israel Pharmaceuticals Ltd, effective March 31, 2023 (SPL set 7bd2646c-f34a-4824-8f66-c41e77db19d2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks
This table is printed in the Sernivo label published by Primus Pharmaceuticals, Inc. of April 22, 2026; the label quoted above does not print one.
| Reaction | 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% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set 0b386ccc-a2d4-4d18-a2d7-e46ff894c674), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,812 reports list betamethasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 730 are coded as a death and 3,086 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Betamethasone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions