Tri-Luma Side Effects

Generic Name: fluocinolone / hydroquinone / tretinoin topical

Note: This page contains side effects data for the generic drug fluocinolone / hydroquinone / tretinoin topical. It is possible that some of the dosage forms included below may not apply to the brand name Tri-Luma.

It is possible that some side effects of Tri-Luma may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to fluocinolone / hydroquinone / tretinoin topical: topical application cream

As well as its needed effects, fluocinolone / hydroquinone / tretinoin topical may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking fluocinolone / hydroquinone / tretinoin topical, check with your doctor immediately:

More common
  • Redness, peeling, drying, itching, or burning of the skin
Less common
  • Darkening of normal skin color
  • irritated skin
  • rash
Incidence not known
  • Blistering, crusting, or flaking of the skin
  • burning and itching of the skin with pinhead-sized red blisters
  • lightening of normal skin color
  • redness and scaling around the mouth
  • severe redness, soreness, or scaling of the skin
  • thinning of the skin with easy bruising

Some fluocinolone / hydroquinone / tretinoin topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Blemishes on the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • pimples
  • raised, dark red, wart-like spots on the skin

For Healthcare Professionals

Applies to fluocinolone / hydroquinone / tretinoin topical: topical cream

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.[Ref]

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.[Ref]

Dermatologic

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Endocrine

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.[Ref]

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

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.[Ref]

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

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.[Ref]

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.[Ref]

References

1. Jablonska S, Groniowska M, Dabroswki J "Comparative evaluation of skin atrophy in man induced by topical corticoids." Br J Dermatol 100 (1979): 193-206

2. du Vivier A, Stoughton RB "Tachyphylaxis to the action of topically applied corticosteroids." Arch Dermatol 111 (1975): 581-3

3. Burry JN "Topical drug addiction: adverse effects of fluorinated corticosteroid creams and ointments." Med J Aust 1 (1973): 393-6

4. Tirlapur VG, Rice-Oxley JM "Facial erythema and telangiectasia with synalar cream." Br J Clin Pract 35 (1981): 275-6

5. "Product Information. Tri-Luma (fluocinolone / hydroquinone / tretinoin topical)." Galderma Laboratories Inc, Fort Worth, TX.

6. "Product Information. Synalar (fluocinolone topical)." Syntex Laboratories Inc, Palo Alto, CA.

7. Weiss JS, Ellis CN, Goldfarb MT, Voorhees JJ "Tretinoin therapy: practical aspects of evaluation and treatment." J Int Med Res 18 Suppl 3 (1990): c41-8

8. Tosti A, Guerra L, Morelli R, Piraccini BM "Contact dermatitis due to topical retinoic acid." Contact Dermatitis 26 (1992): 276-7

9. Heel RC, Brogden RN, Speight TM, Avery GS "Vitamin A acid: a review of its pharmacological properties and therapeutic use in the topical treatment of acne vulgaris." Drugs 14 (1977): 401-19

10. Pace WE "Topical corticosteroids." Can Med Assoc J 108 (1973): 11 passim

11. Thomas JR 3d, Doyle JA "The therapeutic uses of topical vitamin A acid." J Am Acad Dermatol 4 (1981): 505-13

12. Weber G "Rosacea-like dermatitis: contraindication or intolerance reaction to strong steroids." Br J Dermatol 86 (1972): 253-9

13. "Product Information. Capex (fluocinolone topical)." Galderma Laboratories Inc, Fort Worth, TX.

14. "Product Information. Derma-Smooth/FS (fluocinolone topical)." Hill Dermaceuticals Inc, Sanford, FL.

15. Sneddon I "Adverse effect of topical fluorinated corticosteroids in rosacea." Br Med J 1 (1969): 671-3

16. Marsden CW "Fluocinolone acetonide 0.2 per cent cream--a co-operative clinical trial." Br J Dermatol 80 (1968): 614-7

17. Pasricha JS, Gupta R "Contact sensitivity to betamethasone 17-valerate and fluocinolone acetonide." Contact Dermatitis 9 (1983): 330-1

18. Reitamo S, Lauerma AI, Stubb S, Kayhko K, Visa K, Forstrom L "Delayed hypersensitivity to topical corticosteroids." J Am Acad Dermatol 14 (1986): 582-9

19. Cotterill JA "Perioral dermatitis." Br J Dermatol 101 (1979): 259-62

20. Jordan WP Jr, Higgins M, Dvorak J "Allergic contact dermatitis to All-trans-retinoic acid; epicutaneous and leukocyte migration inhibition testing." Contact Dermatitis 1 (1975): 306-10

21. Rosenbluth M "Adverse reaction to retin-A." J Am Dent Assoc 119 (1989): 346

22. Bernstein AL, Leventhal-Rochon JL "Neurotoxicity related to the use of topical tretinoin (Retin-A)." Ann Intern Med 124 (1996): 227-8

23. Tang SC, Chan KC, Chow SP "Osteonecrosis of femoral head after topical steroid therapy." J R Coll Surg Edinb 31 (1986): 321-3

24. Cubey RB "Glaucoma following the application of corticosteroid to the skin of the eyelids." Br J Dermatol 95 (1976): 207-8

25. Brodell LP, Asselin D, Brodell RT "Reversible ectropion after long-term use of topical tretinoin on photodamaged skin." J Am Acad Dermatol 27 (1992): 621-2

26. Meurehg CC, Xochitl Amelio P "Vaginal bleeding and tretinoin cream." Ann Intern Med 113 (1990): 483

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