Dovonex Side Effects

Please note - some side effects for Dovonex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dovonex - for the Consumer

Dovonex Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dovonex Cream:

Dry skin; peeling.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, itching, or worsening of your condition; skin irritation.

Dovonex Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dovonex Solution:

Dry skin; peeling.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, itching, or worsening of your condition; skin irritation.

Side Effects by Body System

Local

Other rare local adverse effects include skin atrophy, hyperpigmentation, and folliculitis.

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

Local side effects at the site of application occur in approximately 20% of treated patients. Irritation, burning, and itching tend to disappear with continued therapy. Less than 10% of treated patients develop erythema, dermatitis, or worsening of psoriasis. Facial dermatitis or eczema has rarely been reported, occasionally in patients without facial psoriasis. Allergic contact dermatitis has been reported in a few patients.

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 of calcipotriene may rarely include 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 is 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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