Trifarotene is an active pharmaceutical ingredient in the Retinoids For Topical Use In Acne group (D10AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised March 13, 2026[1]
Aklief is indicated for the cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present.
How to take
GB
CACanada· Health Canada
1 product
Side effects & warnings
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
General For external use only. Not for ophthalmic use. AKLIEF should not be applied to cuts, abrasions, eczematous or sunburned skin. Avoid contact with the eyes, mouth, lips, angles of the nose, mucous membranes, abraded skin and open wounds.
If contact occurs, rinse thoroughly with warm water. AKLIEF should be applied only to the affected areas. Excessive use should be avoided. If a reaction suggesting allergic / hypersensitivity reactions to any component of the formulation occurs, the use of the product should be discontinued.
Concomitant topical acne therapy is not recommended because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents (see DRUG INTERACTIONS, Drug-Drug Interactions). Avoid concomitant use of dermatologic medications and potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics) that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes.
Drug interactions
Known interactions involving Trifarotene. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL105900071 · revised March 13, 2026
[2]Health Canada (DPD) · 02494175 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. It is recommended that the physician assesses the continued improvement of the patient after three months of treatment.
Special populations Elderly patients The safety and efficacy of Aklief in geriatric patients aged 65 years and above have not been established. Renal and hepatic impairment Aklief has not been studied in patients with renal and hepatic impairment.
Paediatric population The safety and efficacy of Aklief in children below 12 years old have not been established. Method of administration For cutaneous use only. Before using the pump for the first time, prime it by pressing down several times until a small amount of medicine is dispensed (up to 10 times maximum).
The pump is now ready to use. e. forehead, cheeks, nose, and chin). e. reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present. Patients should be instructed to avoid contact with the eyes, eyelids, lips and mucous membranes and to wash their hands after applying the medicinal product.
The use of a moisturizer is recommended as needed from the initiation of treatment, while allowing sufficient time before and after the application of Aklief cream to allow the skin to dry.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 13, 2026[1]
Summary of safety profile Local cutaneous reactions (such as erythema, scaling, dryness, and stinging/burning) were collected separately from other adverse events as a measure of local tolerance. 2% of patients, respectively on the face.
2% of patients had mild, moderate and severe reactions respectively. 4). 5% of patients treated with Aklief cream in clinical studies.
Tabulated summary of adverse reactions:
Adverse reactions reported in the 12-week vehicle-controlled Phase 3 studies in 1220 patients treated with Aklief cream (and for which the rate for Aklief cream exceeds the rate for vehicle cream) are presented in Table 1. The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1 Adverse reactions System Organ Class Frequency Adverse reactions Common Application site irritation Application site pruritus Uncommon Application site pain Application site dryness Application site discolouration Application site erosion Application site rash Application site swelling General disorders and administration site conditions Rare Application site erythema Application site urticaria Application site vesicles Injury, poisoning and procedural complications Common Sunburn Uncommon Skin irritation Acne Dermatitis allergic Erythema Skin and subcutaneous tissue disorders Rare Eczema asteatotic Seborrheic dermatitis Skin burning sensation Skin fissures Skin hyperpigmentation Eye disorders Rare Eyelid exfolliation Eyelid oedema Gastrointestinal disorders Rare Cheilitis Vascular disorders Rare Flushing Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 13, 2026[1]
8). To mitigate the risk of such reactions, patients should be instructed to use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of Aklief cream, or suspend use temporarily. Despite mitigation measures, if severe reactions persist the treatment may be discontinued.
The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Aklief. If a reaction suggesting sensitivity to any component of the formula occurs, the use of Aklief should be discontinued.
Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with the medicinal product, as they may produce additive irritant effects. Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes.
If the product enter the eye, wash immediately and abundantly with luke warm water. Excessive exposure to sunlight, including sunlamps or phototherapy should be avoided during the treatment. Use of a broad-spectrum, water-resistant sunscreen with a Sun Protection Factor (SPF) of 30 or higher and protective clothing over treated areas is recommended when exposure cannot be avoided.
This product contains propylene glycol (E1520) that may cause skin irritation. Aklief also contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 13, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
Patients should be advised to use non-comedogenic cosmetics. Colour cosmetics such as blushes and powders are acceptable, however, make-up cosmetics should be water based only. Cosmetics must be removed by thorough cleansing before the area is treated.
The treatment area should not be covered with dressings or bandages. Weather extremes, such as wind or cold, may be more irritating to some patients using AKLIEF. Skin Local cutaneous reaction Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus are associated with the topical application of retinoids and can also be expected with the use of AKLIEF.
Most of these treatment-related reactions are mild to moderate with few being severe (see ADVERSE REACTIONS). Maximum severity typically occurred within the first 4 weeks of treatment, and decreased with continued use of the medication.
AKLIEF was better tolerated on the trunk than on the face. To mitigate the risk of such treatment-related reactions, patients should be instructed to use a non- comedogenic moisturizer before and after application from the initiation of treatment, and if appropriate reduce the frequency of application of AKLIEF, or discontinue use temporarily until the symptoms subside.
Despite mitigation measures, if severe reactions persist the treatment may be discontinued permanently (see DOSAGE AND ADMINISTRATION). AKLIEF™ (trifarotene) Product Monograph Page 9 of 33 As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF.
Ultraviolet Light and Environmental Exposure As with any retinoid, exposure to excessive sunlight, including sunlamps, should be avoided while using the preparation, or a suitably effective sunscreen product and protective clothing over the treated areas is recommended when exposure cannot be avoided.
Patients with sunburn should be advised not to use AKLIEF until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using AKLIEF.
, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity Carcinogenesis and Mutagenesis See NON-CLINICAL TOXICOLOGY. Special Populations Pregnant Women Orally administered retinoids have been associated with congenital abnormalities.
, damaged skin barrier, excessive use) (see CONTRAINDICATIONS). There have been rare reports of birth defects among babies born to women exposed to topical retinoids during pregnancy. However, there are no adequate and well-controlled studies in pregnant women with AKLIEF; therefore the safety and efficacy of trifarotene in pregnant women has not been established (see CONTRAINDICATIONS).
If the patient believes they have become pregnant while using AKLIEF, they should discontinue treatment immediately and contact their healthcare provider. Women of child-bearing potential should be informed of the potential risk and use effective birth-control measures when AKLIEF is used.
The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. Confirmation that the patient is not pregnant should be received prior to starting treatment and before each new treatment course.
Although there may be less systemic exposure in the treatment of acne of the face and/or trunk alone due to less surface area for application, trifarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans.
AKLIEF™ (trifarotene) Product Monograph Page 10 of 33 Studies in animals with trifarotene by the oral route have shown reproductive toxicity at high systemic exposure with safety margin based on the rat study of about 55-fold compared to the maximum recommended human dose (MRHD), while safety margins based on the rabbit study could not be established (see NON-CLINICAL TOXICOLOGY).
Due to the limited available data and considering the low cutaneous passage of trifarotene, AKLIEF should not be used during pregnancy or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and their healthcare provider notified immediately.
Breastfeeding Women It is unknown whether trifarotene is excreted in human milk following the use of AKLIEF. Oral animal studies have shown that trifarotene is excreted in the milk of lactating rats. In a two-generation study in rats, no relevant plasma levels were detectable in pups […]
This is not medical advice. Consult a qualified healthcare professional.