As with all topical steroids the occasional patient may develop an adverse reaction. Adverse reactions are listed by system organ class. The frequency of adverse reactions is not known (cannot be estimated from the available data).
Immune System Disorders
Local hypersensitivity reactions
Skin and Subcutaneous Tissue Disorders
Dermatitis
Perioral dermatitis
Acne or worsening of acne
Acne rosacea
Extensive treatment, particularly involving occlusive dressings or where skin folds are involved, can result in both local atrophic changes, such as striae, skin thinning and telangiectasia. Mild depigmentation, which may be reversible, hypertrichosis and irreversible striae.
Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4)
Endocrine Disorders
Adrenal suppression.
General Disorders and Administration Site Conditions
Irritation at the site of application
Infections and Infestations
The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy, can result in the spread of opportunist infections.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.