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Trifarotene topical Side Effects

Medically reviewed by Drugs.com. Last updated on April 15, 2020.

For the Consumer

Applies to trifarotene topical: topical application cream

Side effects requiring immediate medical attention

Along with its needed effects, trifarotene topical 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

Side effects not requiring immediate medical attention

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

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 (erythema, scaling, dryness, stinging/burning)

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

Frequency not reported: Application site pain, application site dryness, application site discoloration, application site rash, application site swelling, application site erosion[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 moderate for up to 30% of patients or severe for up to 6% of patients; on the trunk, local tolerability worsened for any of the signs/symptoms compared with baseline to a score of moderate for up to 19% of patients or severe for up to 5% of patients. 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]

Dermatologic

Common (1% to 10%): Sunburn

Frequency not reported: Acne, allergic dermatitis, erythema, skin irritation[Ref]

References

1. "Product Information. Aklief (trifarotene topical)." Galderma Laboratories Inc, Cranbury, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.