Prescription medication · Superpotent Topical Corticosteroid

clobetasol

Name: clobetasol - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Temovate, Clobex. This medicine treats skin problems that cause inflammation and itching.

Compiled by PlainMeds Editorial, Drug Information Editorial Team

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.

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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 →

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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.

How to Take It

Apply a thin layer of this ointment to the affected skin twice a day. Gently and completely rub the ointment into your skin. Do not use more than 50 grams in one week. Do not cover the treated area with bandages or dressings.

This is a plain-language summary of clobetasol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if clobetasol can harm an unborn baby or pass into breast milk.

This is a plain-language summary of clobetasol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of clobetasol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store at room temperature between 59°F and 86°F. Do not refrigerate.

Side Effects (from patient reports)

Based on 5,204 FDA adverse event reports.

Itching

813
Psoriasis

667
Skin rash

593
Tiredness

512
Headache

498
Feeling sick to your stomach

477
Diarrhea

457
Joint pain

430
Pain

399
Peeling skin

358

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?

Do not use it for more than 2 weeks in a row.

How much clobetasol ointment should I use?

Use a thin layer on the affected area twice a day. Do not use more than 50 grams in one week.

Can I use bandages with clobetasol ointment?

No, do not cover the treated area with bandages or dressings.

What should I do if my skin does not improve?

If your skin does not get better in 2 weeks, talk to your doctor.

Can children use clobetasol ointment?

This medicine is not recommended for children under 12 years old.

What should I do if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose.

How should I store clobetasol ointment?

Store it at room temperature between 59°F and 86°F. Do not refrigerate.

Can I use clobetasol ointment if I am pregnant?

Tell your doctor if you are pregnant before using this medicine.

What are the common side effects?

The most common side effects are burning, irritation, and itching.

What if I accidentally swallow some of the ointment?

Call your doctor or poison control center right away.

What are the common side effects of clobetasol?

The most commonly reported side effects of clobetasol include Burning feeling, Skin irritation, Itching. Based on 5,204 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

What drug class is clobetasol?

clobetasol belongs to the Superpotent Topical Corticosteroid drug class. It requires a prescription (Rx). This medicine treats skin problems that cause inflammation and itching.

Is clobetasol safe during pregnancy?

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if clobetasol can harm an unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has clobetasol been recalled?

There are 2 recalls associated with clobetasol products. CGMP Deviations: Firm went out of business and could no longer continue stability studies. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 26, 2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc.

Class II April 26, 2023

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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: January 24, 2025

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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

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