Solage Side Effects

Please note - some side effects for Solage 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 Solage - for the Consumer

Solage

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 Solage:

Burning, dry skin, itching, peeling, redness, stinging, tingling, or warmth at application site; unusual sensitivity to wind and cold.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering, crusting, swelling, or excessive redness of the skin; changes in skin color; lightening of the skin surrounding the treatment area.

Solage Side Effects - for the Professional

Solagé

In clinical trials, adverse reactions were primarily mild to moderate in intensity, occurring in 66% and 30% of patients, respectively. The majority of these events were limited to the skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8).
The most frequent adverse reactions in patients treated with SolagéSolution were erythema (49% of patients), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%).
Some patients experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Ninety-four of 106 patients (89%) had resolution of hypopigmentation upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of patients with hypopigmentation events had resolution within 120 days after the end of treatment. Three of the 106 patients (2.8%) had persistence of hypopigmentation beyond 120 days. Approximately 6% of patients discontinued study participation with SolagéSolution due to adverse reactions. These discontinuations were due primarily to skin redness (erythema) or related cutaneous adverse reactions. SolagéSolution was generally well tolerated.

Side Effects by Body System

General

In general, topical adverse reactions have been primarily mild to moderate in intensity, and occurred in 66% and 30% of patients, respectively. The majority of these reactions were limited to the skin. Approximately 6% of patients discontinued study participation due to adverse reactions.

Dermatologic

Dermatological side effects have included skin reactions in 64% of patients within 8 weeks of therapy. The most frequently reported side effects have included erythema (49%), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%). Temporary hypopigmentation of treated lesions or of the skin surrounding treated lesions in 5% and 7% of patients, respectively have been reported. Halo hypopigmentation, dry skin, rash, crusting, vesicular bullae rash, dermatitis, skin discomfort, and irritant dermatitis have been reported in greater than 1% of patients. Rare cases of depigmentation have also been reported in postmarketing experience. Mequinol-tretinoin topical may induce photosensitivity in some individuals, as well as an increased susceptibility to irritation from wind, cold, and dryness.

Resolution of hypopigmentation occurred in 89% of patients following discontinuation of treatment to the lesion. Another 8% of patients with hypopigmentation had resolution of symptoms in within 120 days after the end of treatment. Persistence of hypopigmentation occurred in 2.8% of patients beyond 120 days.

Hepatic

Hepatic side effects to mequinol-tretinoin topical have not been reported. However, reversible, clinically insignificant changes in liver function tests have been reported following both oral and topical administration of tretinoin. These abnormalities have included elevations in serum bilirubin, alkaline phosphatase, glutamic-oxaloacetic transaminase, and glutamic-pyruvic transaminase.

Nervous system

Nervous system side effects have included at least one case of neurotoxicity in a patient who received tretinoin topical therapy.

A patient with liver disease developed neurological side effects following 4 weeks of tretinoin therapy. Symptoms included headache, memory loss, truncal ataxia, and dysarthria, all of which improved upon temporary discontinuation of medication and recurred when the patient resumed usage. Upon withdrawal of medication a second time, the symptoms resolved within 4 weeks.

Ocular

Ocular side effects to topical tretinoin have included ectropions which have developed infrequently and were reversible. In addition, a transient and harmless stinging of the eye has occurred when tretinoin was applied onto the surrounding skin, and has generally lasted about 30 to 60 seconds.

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