Note: This document contains side effect information about trifarotene topical. Some dosage forms listed on this page may not apply to the brand name Aklief.

Applies to trifarotene topical: topical application cream.

Serious side effects of Aklief

Along with its needed effects, trifarotene topical (the active ingredient contained in Aklief) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking trifarotene topical:

More common

• Itching or redness at the application site (severe)

Rare

• Dryness, discoloration, pain, or swelling at the application site
• skin rash, hives, itching, or redness

Other side effects of Aklief

Some side effects of trifarotene topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning or stinging at the application site

For Healthcare Professionals

Applies to trifarotene topical: topical cream.

Cardiovascular

Rare (0.01% to 0.1%): Flushing

Dermatologic

Common (1% to 10%): Sunburn

Uncommon (0.1% to 1%): Skin irritation, acne, allergic dermatitis, erythema

Rare (0.01% to 0.1%): Asteatotic eczema, seborrheic dermatitis, skin burning sensation, skin fissures, skin hyperpigmentation, urticaria

Frequency not reported: Allergic dermatitis^[Ref]

Gastrointestinal

Rare (0.01% to 0.1%): Cheilitis

General

The most common side effects were sunburn, application site pruritus, and application site irritation.^[Ref]

Local

Very common (10% or more): Application site/local tolerability worsened (scaling, dryness, stinging/burning)

Common (1% to 10%): Application site irritation, application site pruritus

Uncommon (0.1% to 1%): Application site pain, rash, dryness, discoloration, swelling, erosion

Rare (0.01% to 0.1%): Application site vesicles^[Ref]

Application site tolerability was evaluated by active assessment of erythema, scaling, dryness, and stinging/burning and collected separately. In the 12-week phase 3 clinical trials, these signs/symptoms were assessed at baseline and at least once postbaseline. On the face, local tolerability worsened for any of the signs/symptoms compared with baseline to a score of mild, moderate, and severe intensity for up to 39%, 30% and 6% of patients; on the trunk, local tolerability worsened for any of the signs/symptoms compared with baseline to a score of mild, moderate, and severe intensity for up to 33%, 19% and 5% of patients respectively. The scores reached maximum severity at week 1 and week 2 to 4 of therapy for the face and trunk, respectively, and decreased thereafter.^[Ref]

Ocular

Rare (0.01% to 0.1%): Eyelid exfoliation, eyelid edema

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Influenza

Nervous system

Common (1% to 10%): Headache