What the label lists and what reports show
Clobetasol side effects
Clobetasol's FDA label lists its adverse reactions in its own words. FAERS holds 10,472 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 pruritus (926 reports).
- Generic listed
Check it at the source: the clobetasol FDA label on DailyMed (effective April 21, 2026, Encube Ethicals, Inc.); 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 clobetasol propionate topical spray?Clobetasol propionate topical spray can pass through your skin. Too much clobetasol propionate topical spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working. The most common side effects with clobetasol propionate topical spray include: burning at treated site upper respiratory tract infection runny nose sore throat dry, itchy and reddened skin If you go to another doctor for illness, injury or surgery, tell that doctor you are using clobetasol propionate topical spray. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of clobetasol propionate topical spray. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. […]
Source: FDA drug label (CLOBETASOL PROPIONATE), Alembic Pharmaceuticals Inc., effective July 17, 2026 (SPL set a83d212b-a970-4ee7-8431-fead6b2e7f9d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsClobetasol Propionate Topical Solution, 0.05% is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for Clobetasol Propionate Topical Solution, 0.05% have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. …
Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence)
This table is printed in the CLOBETASOL PROPIONATE label published by Alembic Pharmaceuticals Inc. of July 17, 2026; the label quoted above does not print one.
| Adverse Reaction | Clobetasol Propionate 0.05% Spray (N=120) | Vehicle Spray (N=120) |
|---|---|---|
| General disorders and administration site conditions | 50 (42%) | 56 (47%) |
| Application site burning | 48 (40%) | 56 (47%) |
| Application site dryness | 2 (2%) | 0 (0%) |
| Application site irritation | 1 (1%) | 0 (0%) |
| Application site pain | 1 (1%) | 2 (2%) |
| Application site pigmentation changes | 1 (1%) | 0 (0%) |
| Application site pruritus | 4 (3%) | 3 (3%) |
| Infections and infestations | 17 (14%) | 12 (10%) |
| Nasopharyngitis | 6 (5%) | 3 (3%) |
| Pharyngitis streptococcal | 1 (1%) | 0 (0%) |
| Upper respiratory tract infection | 10 (8%) | 2 (2%) |
| Skin and subcutaneous tissue disorders | 4 (3%) | 2 (2%) |
| Eczema asteatotic | 2 (2%) | 0 (0%) |
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, Encube Ethicals, Inc., effective April 21, 2026 (SPL set 8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,472 reports list clobetasol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 434 are coded as a death and 2,015 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 18 reactions below, 3 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?
- Clobetasol: 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