Trifarotene Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 16, 2024.

Applies to trifarotene topical: topical application cream.

Serious side effects of trifarotene topical

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 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 trifarotene topical

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

Further information

Trifarotene topical 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.

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

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