Drug Safety Information for CLOBEX (Clobetasol propionate)

Safety-related Labeling Changes for OLUX (CLOBETASOL PROPIONATE) Rx Drug: FDA Link

Safety-related Labeling Changes for OLUX E (CLOBETASOL PROPIONATE) Rx Drug: FDA Link

Adverse Drug Reactions for CLOBEX* (Clobetasol propionate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CLOBEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Psoriasis480
2Drug ineffective438
3Nausea265
4Rash264
5Headache247
6Diarrhoea236
7Fatigue228
8Pruritus*226
9Pain*224
10Injection site pain217
11Arthralgia189
12Pyrexia180
13Dyspnoea179
14Erythema170
15Dizziness154
16Malaise*148
17Pain in extremity144
18Vomiting144
19Off label use139
20Oedema peripheral133

* This side effect also appears in "Top 10 Side Effects of CLOBEX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CLOBEX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Psoriasis*3754
2Product used for unknown indication3238
3Rash482
4Eczema*455
5Dermatitis diaper232
6Lichen sclerosus212
7Pruritus182
8Pemphigoid170
9Dermatitis atopic142
10Skin disorder135

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CLOBEX

Total Reports Filed with FDA: 24205


Number of FDA Adverse Event Reports by Patient Age for CLOBEX

Total Reports Filed with FDA: 24205*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clobetasol propionate (Clobetasol, Clobevate, Olux-e, Dermovate, Clobex, Olux, Clodan, Olux e, Embeline e, Cormax, Temovate e, Embeline, Temovate)

Charts are based on 24205 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CLOBEX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.