Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism and suppression of the HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.
Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1,000 and <1/100), rare (≥ 1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System Organ Class | Frequency | Adverse reaction |
Immune System Disorders | Not known | Hypersensitivity |
Endocrine Disorders | Not known | Hypothalamic-pituitary adrenal (HPA) axis suppression Hypercorticism |
Skin and Subcutaneous Tissue Disorders | Not known | Skin atrophy Pustular psoriasis 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) |
Eye disorders | Not known | Vision, blurred (see also section 4.4) |
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 Google Play or Apple App Store.