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Tri-Luma

Last reviewed on RxList: 4/11/2014
Tri-Luma Side Effects Center

Last reviewed on RxList 8/10/2015

Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is a combination of three medications (a steroid, a skin bleaching agent, and a form of vitamin A) used to treat melasma (dark skin patches) of the face. Common side effects of Tri-Luma include mild burning, stinging, redness, dryness, tingling, itching, swelling, or peeling of your skin; rash; acne; skin bumps or blisters; or more noticeable red lines or blood vessels showing through your skin.

Tri-Luma Cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Tri-Luma may interact with diuretics (water pills), antibiotics, sulfa drugs, phenothiazines, birth control pills, or hormone replacement therapy. Tell your doctor all medications you are taking. Tri-Luma is not recommended for use during pregnancy. One medication in this product (tretinoin) has caused harm to a fetus when taken by mouth. It is not known whether these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding. Avoid skin-to-skin contact with your infant in areas where this product has been used.

Our Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tri-Luma Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor if you have any of these serious side effects:

  • darkening of the treated skin;
  • severe skin irritation, blistering, oozing, scaling, or crusting;
  • severe burning or swelling of the skin; or
  • irritation of your eyes, nose, or mouth.

Less serious side effects may include:

  • mild redness, burning, stinging, tingling, itching, swelling, dryness, or peeling of your skin;
  • rash;
  • acne;
  • skin bumps or blisters; or
  • more noticeable red lines or blood vessels showing through your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tri-Luma (Hydroquinone 4% Cream)

Tri-Luma Professional Information

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the controlled clinical trials, adverse events were monitored in the 161 subjects who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The 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 trials are summarized (in decreasing order of frequency) as follows:

Table 1: Incidence and Frequency of Treatment-related Adverse Events with TRI-LUMA Cream in at Least 1% or More of Subjects (N=161)

Adverse Event n (%)
Erythema 66 (41%)
Desquamation 61 (38%)
Burning 29 (18%)
Dryness 23 (14%)
Pruritus 18 (11%)
Acne 8 (5%)
Paresthesia 5 (3%)
Telangiectasia 5 (3%)
Hyperesthesia 3 (2%)
Pigmentary changes 3 (2%)
Irritation 3 (2%)
Papules 2 (1%)
Acne-like rash 1 (1%)
Rosacea 1 (1%)
Dry mouth 1 (1%)
Rash 1 (1%)
Vesicles 1 (1%)

In an open-label trial, subjects who 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.

The following local adverse reactions have been reported 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.

Read the entire FDA prescribing information for Tri-Luma (Hydroquinone 4% Cream)

Related Resources for Tri-Luma

Read the Tri-Luma User Reviews »

© Tri-Luma Patient Information is supplied by Cerner Multum, Inc. and Tri-Luma Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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