Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aklief (Trifarotene-topical). If you are concerned about side effects, discuss the risks and benefits of Aklief (Trifarotene-topical) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning
• dryness
• loss of skin pigment
• peeling
• skin redness
• stinging

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of an allergic reaction (e.g., extreme stinging, burning, redness, swelling)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aklief (Trifarotene-topical).

Each gram of white cream contains 50 µg trifarotene. Nonmedicinal ingredients: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate with isohexadecane, polysorbate 80 and sorbitan oleate, cyclomethicone 5, ethanol (96% alcohol), phenoxyethanol, propylene glycol, triglycerides medium-chain and purified water.

Do not take this medication if you:

• are allergic to trifarotene or any ingredients of the medication
• are pregnant or planning to become pregnant
• have Eczema or seborrheic dermatitis

There may be an interaction between trifarotene and any of the following:

• other medications that increase the skin’s sensitivity to sun exposure (e.g., certain diuretics, quinolone antibiotics, Tetracycline antibiotics, certain sedatives, “sulfa” antibiotics)
• other acne medications that contain sulfur, resorcinol or salicylic acid

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Aklief (Trifarotene-topical). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Aklief (Trifarotene-topical).

Exposure to sunlight: Aklief (Trifarotene-topical) can make the skin more sensitive to sunlight. Make sure you use sunscreen (minimum SPF 30) and protective clothing when exposed to sunlight. If you have a Sunburn, you should not use trifarotene until you have fully recovered.

Skin Care: Trifarotene can make your skin dry and possibly irritated. It is important to avoid using other skin products or treatments with strong drying or irritant effects. These products and procedures may include electrolysis, hair depilatories, medicated soaps or shampoos, permanent wave solution, waxes, and products containing high amounts of alcohol, astringents, spices, or lime peel.

Exposure to wind and cold may also dry and irritate your skin.

Other acne medications may contribute to skin irritation. Discuss your options with your doctor.

Pregnancy: It is recommended that pregnant women do not use trifarotene. When similar medications have been taken by mouth during pregnancy, the babies born to these women were at an increased risk of birth defects. Because the amount of Aklief (Trifarotene-topical) that is absorbed through the skin varies, there is a risk that the unborn baby may be exposed to trifarotene if it is used during pregnancy. Women who may become pregnant should use an effective method of birth control while using Aklief (Trifarotene-topical). If you become pregnant while taking Aklief (Trifarotene-topical), contact your doctor immediately.

Breast-feeding: It is not known if trifarotene passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 12 years of age.