Dovonex Cream Side Effects

Please note - some side effects for Dovonex Cream may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: topical cream; topical foam; topical ointment; topical solution

Dermatologic

Dermatologic side effects associated with calcipotriene topical ointment and/or cream have included burning, itching, and skin irritation (up to 15%); erythema, dry skin, peeling, rash, dermatitis, and worsening of psoriasis including development of facial/scalp psoriasis (up to 10%); and skin atrophy, hyperpigmentation, and folliculitis (less than 1%). Calcipotriene topical solution has been associated with transient burning, stinging, and tingling (about 23%); rash (about 11%); and dry skin, irritation, and worsening of psoriasis (up to 5%). Side effects reported in greater than 1% of patients and in a higher rate in patients treated with calcipotriene topical foam compared to vehicle were limited to erythema. Facial dermatitis or eczema has rarely been reported, occasionally in patients without facial psoriasis. Allergic contact dermatitis has been reported in a few patients. Calcipotriene phototoxicity has been reported.

Clinical trials have shown a higher incidence of severe skin-related adverse reactions in patients older than 65 years of age.

Metabolic

One patient with symptomatic hypercalcemia had moderate renal impairment. This patient used 200 grams of ointment over the course of a week. At least two patients have experienced hypercalcemia while using less than 100 grams per week. A lower dose of 10 grams per week was tried in one of these patients, however hypercalcemia returned.

There have been several studies of the effect of calcipotriene on serum calcium and urinary calcium. One study observed 34 patients with psoriasis treated with 8.2 to 95.4 grams per week. No difference in calcium or bone metabolism was noted when compared to patients treated with placebo. Another study where 12 of 24 patients received 30 grams per day for 14 days reported no significant alterations in blood or urine calcium concentrations. However, in a higher dose study, 10 patients treated with 100 grams calcipotriene per week experienced an increase in urinary calcium from 4.75 mmol/24 hours to 5.89 mmol/24 hours over four weeks of treatment.

Metabolic side effects have rarely included transient increases in serum calcium. Symptomatic hypercalcemia has been reported in a few individuals, particularly those with extensive, unstable disease using more than 100 grams of ointment per week. Hypercalcemia has been reported in less than 1% of patients and was reversible upon drug discontinuation.

Oncologic

Oncologic side effects have included a reduction in the time required for UVR to induce the formation of skin tumors which was observed in an animal study (statistically significant in males only).

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