The clinical trial program for Xamiol gel has so far included >4,400 patients of whom more than 1,900 were treated with Xamiol gel.
Approximately 8% of patients treated with Xamiol gel experienced a nonserious adverse drug reaction.
Based on data from clinical trials, the only known common adverse drug reaction is pruritus. Uncommon adverse drug reactions are burning sensation of skin, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash and eye irritation. These adverse drug reactions were all nonserious local reactions.
The adverse drug reactions are listed by MedDRA System Organ Class, and the individual adverse drug reactions are listed starting with the most frequently reported.
Uncommon (≥1/1,000 and <1/100): Eye irritation.
Skin and Subcutaneous Tissue Disorders:
Common (≥1/100 and <1/10): Pruritus. Uncommon (≥1/1,000 and <1/100): Burning sensation of skin, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash.
Adverse drug reactions observed for calcipotriol and betamethasone, respectively:
Adverse drug reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, aggravated psoriasis, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial edema. Systemic effects after topical use may appear very rarely causing hypercalcemia or hypercalciuria.
Betamethasone (as dipropionate):
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis, there may be a risk of generalized pustular psoriasis.
Systemic effects due to topical use of corticosteroids are rare in adults, however, they can be severe. Adrenocortical suppression, cataract, infections and increase of intraocular 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.