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Tri-Luma Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is used to treat melasma (dark skin patches) of the face. Tri-Luma contains three medications: fluocinolone is a steroid, hydroquinone topical is a skin bleaching agent, and tretinoin topical is a form of vitamin A. Common side effects include mild burning, stinging, redness, dryness, or acne.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tri-Luma in Detail - Patient Information: Side Effects
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;
- 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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tri-Luma Overview - Patient Information: Side Effects
Mild burning, stinging, redness, dryness, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), "hair bumps" (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity.
Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor immediately if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tri-Luma (Hydroquinone 4% Cream)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tri-Luma FDA Prescribing Information: Side Effects
In the controlled clinical trials, adverse events were monitored in the 161 patients who used TRI-LUMA® (hydroquinone 4% cream) 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® (hydroquinone 4% cream) 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® (hydroquinone 4% cream) 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 erythe-ma, 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® (hydroquinone 4% cream) Cream from the controlled clinical studies and the long-term study are summarized (in decreasing order of frequency).
Incidence and Frequency of Treatment-related Adverse Events
with TRI-LUMA® (hydroquinone 4% cream) Cream in at least 1% or more of Patients (N=161)
|Adverse Event||Number (%) of Patient|
|Pigmentary changes||3 (2%)|
|Acne-like rash||1 (1%)|
|Dry mouth||1 (1%)|
In an open-label long-term safety study, patients who have had cumulative treatment of melasma with TRI-LUMA® (hydroquinone 4% cream) Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.
Summary of Most Common Treatment-Related Adverse Events
(TRAE)a Study 29
|Preferred Term||Number (%) of Patients|
|Patients with at least 180 Cumulative Days
of TRI-LUMA® (hydroquinone 4% cream)
Treatment Days (N=314)
|Total number of TRAEa||326 (57.29)||202 (64.33)|
|Application site erythema||166 (29.17)||105 (33.44)|
|Application site desquamation||145 (25.48)||91 (28.98)|
|Application site dryness||46 (8.08)||27 (8.60)|
|Application site burning||38 (6.68)||25 (7.96)|
|Application site inflammation||31 (5.45)||24 (7.64)|
|Application site reaction nos||31 (5.45||17 (5.41)|
|Application site rash||30 (5.27)||18 (5.73)|
|Application site pruritus||24 (4.22)||18 (5.73)|
|Application site pigmentation changes||23 (4.04)||18 (5.73)|
|a Defined as “probably”
or “possibly” related to study medication
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® (hydroquinone 4% cream) 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® (hydroquinone 4% cream) 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® (hydroquinone 4% cream) Cream or its components.
Read the entire FDA prescribing information for Tri-Luma (Hydroquinone 4% Cream) »
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