What the label lists and what reports show
Betamethasone and calcipotriene side effects
Betamethasone and calcipotriene's FDA label: “The most common adverse reactions (≥1%) are pruritus and scaly rash.” FAERS holds 3,232 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 diarrhoea (224 reports).
- Generic listed
Check it at the source: the betamethasone and calcipotriene FDA label on DailyMed (effective December 12, 2022, Prasco Laboratories); 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 Calcipotriene and Betamethasone Dipropionate Ointment?The most common side effects are: itching rash Other less common side effects with Calcipotriene and Betamethasone Dipropionate Ointment include: redness of the skin skin irritation skin burning inflamed hair pores (folliculitis) change of skin color (at the site of application) rash with pus-filled papules thinning of the skin (atrophy) swollen fine blood vessels (this makes your skin appear red at the site of application) Calcipotriene and Betamethasone Dipropionate Ointment may cause serious side effects. Serious side effects are more likely to happen if you use too much Calcipotriene and Betamethasone Dipropionate Ointment, use it for too long, or use it with other topical medicines that contain corticosteroids, calcipotriene, or certain other ingredients. Check with your doctor before using other topical medicines. […]
Source: FDA drug label, NDA021852 (Leo Pharma As), as published by Prasco Laboratories, effective December 12, 2022 (SPL set d9493e66-251c-426c-90a8-1bf1e526ab85), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥1%) are pruritus and scaly rash.
Table 1 Adverse Events Reported by ≥1% of Subjects by Preferred Term
| Reaction | Calcipotriene and Betamethasone Dipropionate Ointment N = 2448 | Calcipotriene N = 3197 | Betamethasone dipropionate N = 1164 | Vehicle N = 470 |
|---|---|---|---|---|
| Any Adverse Event | 663 (27.1) | 1055 (33.0) | 329 (28.3) | 157 (33.4) |
| Pruritus | 75 (3.1) | 183 (5.7) | 38 (3.3) | 43 (9.1) |
| Headache | 69 (2.8) | 75 (2.3) | 44 (3.8) | 12 (2.6) |
| Nasopharyngitis | 56 (2.3) | 77 (2.4) | 34 (2.9) | 9 (1.9) |
| Psoriasis | 30 (1.2) | 47 (1.5) | 14 (1.2) | 5 (1.1) |
| Rash scaly | 30 (1.2) | 40 (1.3) | 0 (0.0) | 1 (0.2) |
| Influenza | 23 (0.9) | 34 (1.1) | 14 (1.2) | 6 (1.3) |
| Upper respiratory tract infection | 20 (0.8) | 19 (0.6) | 12 (1.0) | 3 (0.6) |
| Erythema | 15 (0.6) | 54 (1.7) | 3 (0.3) | 5 (1.1) |
| Application site pruritus | 13 (0.5) | 24 (0.8) | 10 (0.9) | 6 (1.3) |
| Skin irritation | 11 (0.4) | 60 (1.9) | 8 (0.7) | 5 (1.1) |
| Pain | 7 (0.3) | 12 (0.4) | 3 (0.3) | 5 (1.1) |
| Burning sensation | 6 (0.2) | 30 (0.9) | 3 (0.3) | 6 (1.3) |
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.
From the label: adverse reactions, continuedBecause 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 practice. The most common adverse reactions (≥1%) are pruritus and scaly rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to Calcipotriene and Betamethasone Dipropionate Ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Calcipotriene and Betamethasone Dipropionate Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most subjects received once daily application, and the median weekly dose was 24.5 g. …
Source: FDA drug label, NDA021852 (Leo Pharma As), as published by Prasco Laboratories, effective December 12, 2022 (SPL set d9493e66-251c-426c-90a8-1bf1e526ab85), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,232 reports list betamethasone and calcipotriene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 760 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 20 reactions below, 5 are 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 and calcipotriene: 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