Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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
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.
5 WARNINGS AND PRECAUTIONS TRI-LUMA Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people.
If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue TRI-LUMA.
( 5.1 ) TRI-LUMA Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy.
( 5.2 ) 5.1 Hypersensitivity TRI-LUMA Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals.
If anaphylaxis, asthma or other clinically significant hypersensitivity reactions occur, institute appropriate therapy and discontinue TRI-LUMA.
Like all medications, Tri-Luma can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: