Temovateclobetasol
According to the FDA label: Clobetasol propionate topical solution, USP is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
10,767 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Temovate in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 1,147 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pruritus 862 reports
Off Label Use 680 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Psoriasis 679 reports
A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Full definition in the glossary →Rash 628 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Fatigue 531 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 517 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Product Use in Unapproved Indication 496 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Nausea 491 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 474 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 437 reports
Pain 417 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Skin Exfoliation 372 reports
Peeling or shedding of the outer layer of skin.
Full definition in the glossary →Dry Skin 356 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →Erythema 347 reports
Redness of the skin.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 6,127 |
| Male | 3,523 |
| Unknown | 12 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 279 |
| 18-34 | 618 |
| 35-49 | 1,000 |
| 50-64 | 2,063 |
| 65-74 | 1,499 |
| 75+ | 1,083 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Temovate. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 5,625 |
| Other Serious | 3,692 |
| Hospitalization | 2,095 |
| Death | 460 |
| Life-Threatening | 247 |
| Disability | 195 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Temovate. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 19 |
| 2005 | 21 |
| 2006 | 65 |
| 2007 | 95 |
| 2008 | 99 |
| 2009 | 139 |
| 2010 | 157 |
| 2011 | 243 |
| 2012 | 381 |
| 2013 | 249 |
| 2014 | 272 |
| 2015 | 506 |
| 2016 | 501 |
| 2017 | 604 |
| 2018 | 524 |
| 2019 | 544 |
| 2020 | 601 |
| 2021 | 631 |
| 2022 | 954 |
| 2023 | 1,283 |
| 2024 | 1,214 |
| 2025 | 1,356 |
| 2026 (partial) | 309 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Temovate
In FDA adverse event reports that mention Temovate, these medications appeared most often in the same report.
- Dupilumab (1,906 reports)
- Ergocalciferol (1,462 reports)
- Omeprazole (1,165 reports)
- Aspirin (1,145 reports)
- Acetaminophen (1,088 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026