Prescription medication · Superpotent Topical Corticosteroid
clobetasol
Also sold as Temovate, Clobex. This medicine treats skin problems that cause inflammation and itching.
Data updated 2026-05-15
- 5,204
- FDA reports
- 2
- Recall records
What the data shows
clobetasol (Temovate) is a prescription Superpotent Topical Corticosteroid, with 5,204 FDA adverse-event reports on file.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
clobetasol (Temovate) is a prescription Superpotent Topical Corticosteroid. This medicine treats skin problems that cause inflammation and itching.
Clobetasol ointment is a very strong steroid medicine used on the skin. It helps reduce swelling, itching, and redness.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.11/unit
Generic Available
Yes (53 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: CLOBETASOL 0.05% CREAM
Same CMS presentation as the headline generic unit price above (5 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -18.5% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| April 17, 2024 | $0.1308/GM | - | 2 |
| May 22, 2024 | $0.1497/GM | +14.5% | 1 |
| July 17, 2024 | $0.1292/GM | -13.7% | 2 |
| September 18, 2024 | $0.1621/GM | +25.5% | 3 |
| December 18, 2024 | $0.1321/GM | -18.5% | 32 |
What it does
This medicine treats skin problems that cause inflammation and itching.
Common side effects
Burning feeling, Skin irritation, Itching
Key warnings
Using too much clobetasol or using it for too long can affect your hormone levels.
The sections below are summarized in plain English from clobetasol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Clobetasol is a strong corticosteroid. It works by reducing inflammation in the skin. This helps to relieve itching and other skin problems.
Side Effects (from patient reports)
Based on 5,204 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for clobetasol, by number of reports
- Itching
Itching
813 reports
- Psoriasis
Psoriasis
667 reports
- Skin rash
Skin rash
593 reports
- Tiredness
Tiredness
512 reports
- Headache
Headache
498 reports
- Feeling sick to your stomach
Feeling sick to your stomach
477 reports
- Diarrhea
Diarrhea
457 reports
- Joint pain
Joint pain
430 reports
- Pain
Pain
399 reports
- Peeling skin
Peeling skin
358 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
Using too much clobetasol or using it for too long can affect your hormone levels. This medicine is not recommended for children under 12 years old.
Common Questions
How long can I use clobetasol ointment?
How much clobetasol ointment should I use?
Can I use bandages with clobetasol ointment?
What should I do if my skin does not improve?
Can children use clobetasol ointment?
What should I do if I miss a dose?
How should I store clobetasol ointment?
Can I use clobetasol ointment if I am pregnant?
What are the common side effects?
What if I accidentally swallow some of the ointment?
What are the common side effects of clobetasol?
What drug class is clobetasol?
What pregnancy or breastfeeding source fields are listed for clobetasol?
Has clobetasol been recalled?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
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What the FDA Data Shows for clobetasol
The FDA label for clobetasol (sold under brand names such as Temovate, Clobex) classifies it as a prescription-only medication in the Superpotent Topical Corticosteroid class. This medicine treats skin problems that cause inflammation and itching. Official labeling lists 3 commonly reported side effects, including Burning feeling, Skin irritation, Itching.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,204 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.11.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 24, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages