Tri-Luma Side Effects

Please note - some side effects for Tri-Luma 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 Tri-Luma - for the Consumer

Tri-Luma

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 Tri-Luma:

Acne; numbness or tingling of the skin; redness, peeling, mild burning, irritation, stinging, dryness, itching, or feeling of warmth at the application site; sensitivity to sunlight.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive hair growth; gradual blue-black darkening of the skin; inflamed hair follicles; inflammation around the mouth; loss of skin color; muscle weakness; severe or persistent burning, redness, swelling, blistering, oozing, crusting, or irritation of the skin; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Tri-Luma Side Effects - for the Professional

Tri-Luma

In the controlled clinical trials, adverse events were monitored in the 161 patients who used Tri-Luma® Cream once daily during an 8-week treatment period. There were 102 (63%) patients who experienced at least one treatment-related adverse event during these studies. In the long-term clinical study, from a total of 314 patients treated with Tri-Luma® Cream for at least 180 cumulative days, there were 202 (64%) patients who experienced at least one treatment-related adverse event. No significant increase in severity or incidence of the adverse events was observed from long term use of Tri-Luma® Cream compared with events reported during the 8-week controlled clinical studies. The most frequently reported adverse events that were observed from the controlled clinical trials and the long term safety were erythema, desquamation, and burning, at the site of application. The number and percentages of these events were markedly lower in the long-term study than in the controlled clinical studies. The great majority of these events were mild to moderate in severity.

Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with Tri-Luma® Cream from the controlled clinical studies and the long-term study are summarized (in decreasing order of frequency).

Inan open-label long-term safety study, patients who have had cumulative treatment of melasma with Tri-Luma® Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.

Data source: Section 14.3, Tables 8.1.1, 8.1.2, and 8.1.3

The severity, incidence and type of adverse events experienced from 6 months cumulative use were not significantly different from the events reported for all patients.

The incidence of application site pigmentation changes that occurred in both the controlled and long-term safety studies included 11 occurrences of hypopigmentation and 18 occurrences of hyperpigmentation in 27 patients.

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Tri-Luma® Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy.

Cutaneous hypersensitivity to the active ingredients of Tri-Luma® Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to Tri-Luma® Cream or its components.

Side Effects by Body System

Local

Local side effects have been reported the most frequently. These have included erythema (41%), desquamation (38%), burning (18%), dryness (14%), pruritus (11%), inflammation (5.45%), nonspecific application site reaction (5%), acne (5%), telangiectasia (3%), pigmentary changes (2%), irritation (2%), papules (1%), acne-like rash (1%), rosacea (1%), rash (1%), and vesicles (1%).

Local side effects associated with fluocinolone topical have included burning, itching, or irritation, especially when applied to denuded skin. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding. Allergic contact dermatitis and perioral dermatitis/rosacea-like dermatitis has been occasionally reported with topical corticosteroid usage. In addition, topical corticosteroid use, such as fluocinolone, may inhibit local immune response rendering the skin more susceptible to infections. Reports of folliculitis have occasionally been associated with fluocinolone topical.

Local side effects associated with tretinoin topical have frequently included retinoid dermatitis which is characterized by local erythema, dryness, scaling, pruritus, and variable degrees of irritation.

Local side effects associated with hydroquinone have rarely included exogenous ochronosis.

Pigmentary changes associated with fluocinolone-hydroquinone-tretinoin topical use are hyperpigmentation and hypopigmentation.

Skin atrophy, associated with fluocinolone, may become evident within one to two months of use and is due to the inhibitory effect of corticosteroids on collagen formation. Skin on the face, axillae, and groin appear to be most susceptible to the adverse, long-term effects of topical fluocinolone. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Perioral dermatitis or rosacea-like dermatitis has occurred in patients treated with potent topical corticosteroids who are of seborrheic skin type. This condition may flare temporarily upon discontinuation of topical steroids, prompting patients to continue their use. If topical corticosteroids are discontinued, this flare and the initial dermatitis generally resolves over a few weeks.

Local reactions associated with tretinoin topical are commonly observed during the initial phase of therapy, but may not appear until as late as ten weeks into treatment. The dermatitis generally subsides with prolonged use of the medication, although in some cases may require a dosage adjustment or discontinuation of therapy. True contact dermatitis has been reported and confirmed with patch testing and leukocyte migration inhibition studies, but is uncommon. Rarely, there may be temporary hyper- or hypopigmentation following repeated applications.

There are rare reports of exogenous ochronosis associated with hydroquinone therapy. The symptoms consist of a gradual blue-black darkening of the skin. The occurrence of this condition should prompt discontinuation of fluocinolone-hydroquinone-tretinoin topical therapy. The majority of the patients with this condition are Black; however, there are reports involving Caucasians and Hispanics.

Dermatologic

Dermatologic side effects are the most frequently reported side effects associated with the use of tretinoin topical. In double-blind, vehicle-controlled studies involving 339 patients who applied tretinoin topical 0.02% to their faces, adverse reactions associated with the use of tretinoin topical were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 24% of all study patients, skin irritation was reported that was either severe (about 7%), led to temporary discontinuation of tretinoin topical 0.02% (about 20%), or led to use of a mild topical corticosteroid. About 5% of patients using tretinoin topical 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of tretinoin topical because of adverse reactions.

A severe cutaneous reaction was reported in a patient who had an ice pack placed over an area treated with topical tretinoin. The area became pigmented and indurated, and the pigmentation persisted for an extensive length of time.

Dermatologic side effects associated with tretinoin topical have included peeling, dry skin, burning, stinging, erythema, pruritus, and skin irritation. Topical tretinoin may induce photosensitivity in some individuals, as well as an increased susceptibility to irritation from wind, cold, and dryness.

Nervous system

A patient with preexisting hepatic disease developed neurological side effects following 4 weeks of tretinoin topical administration. 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.

Nervous system side effects have included paresthesia (3%) and hyperesthesia (2%).

Nervous system side effects associated with tretinoin topical have included a single case of neurotoxicity.

Endocrine

Endocrine side effects associated with fluocinolone topical have rarely included suppression of the hypothalamic-pituitary-adrenal axis.

The rare suppression of the hypothalamic-pituitary-adrenal axis is more likely when higher potency topical corticosteroids are used over extensive areas and/or when occlusive dressings are applied.

Ocular

Ocular side effects associated with fluocinolone topical have rarely included glaucoma (1 case).

Ocular side effects associated with tretinoin topical have rarely included reversible ectropion. Transient, lasting approximately 30 to 60 seconds, and harmless stinging of the eye has been associated with tretinoin topical following application onto the skin surrounding the ophthalmic area.

A young male developed glaucoma following application of a topical corticosteroid to his eyelids for a period of several years.

Genitourinary

Genitourinary side effects associated with tretinoin have included an isolated case of vaginal bleeding in a postmenopausal woman and confirmed upon rechallenge. Estrogen levels appeared not to have been affected.

Hepatic

Hepatic side effects associated with tretinoin topical and oral have included reversible, clinically insignificant, changes in liver function tests including elevations in serum bilirubin, alkaline phosphatase, glutamic-oxaloacetic transaminase, and glutamic-pyruvic transaminase.

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