The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies including post-authorisation safety studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are various skin reactions, like pruritus, and skin exfoliation.
Pustular psoriasis and hypercalcaemia have been reported.
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000). (See table.)
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In an uncontrolled open study, 33 adolescents aged 12-17 years with psoriasis vulgaris were treated with Daivobet ointment for 4 weeks to a maximum of 56 g per week. No new adverse events were observed and no concerns regarding systemic corticosteroid effect were identified. The size of this study does however not allow firm conclusions regarding the safety profile of Daivobet ointment in children and adolescents.
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively: Calcipotriol: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.
Betamethasone (as dipropionate): Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioraldermatitis, allergic contact dermatitis, depigmentation and colloid milia.
When treating psoriasis there may be a risk of generalised pustular psoriasis.
Systemic effects due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment.
Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment.