Aklief Side Effects
Generic name: trifarotene topical
Medically reviewed by Drugs.com. Last updated on Sep 6, 2024.
Note: This document provides detailed information about Aklief Side Effects associated with trifarotene topical. Some dosage forms listed on this page may not apply specifically 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 side effects
- itching or redness at the application site (severe)
Rare side effects
- 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 side effects
- burning or stinging at the application site
For healthcare professionals
Applies to trifarotene topical: topical cream.
General adverse events
The most common side effects were sunburn, application site pruritus, and application site irritation.[Ref]
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
Cardiovascular
- Rare (0.01% to 0.1%): Flushing
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
References
1. (2019) "Product Information. Aklief (trifarotene topical)." Galderma Laboratories Inc
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Further information
Aklief side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.