Important safety information for Tretinoin

What is the FDA-approved use of tretinoin?

Tretinoin is a topical medication that is used to treat acne and to reduce the appearance of fine lines and wrinkles and other signs of photoaging on the face.

Who should not use tretinoin?

Do not use tretinoin if:

  • You are allergic to tretinoin.

  • You are pregnant or breastfeeding, you are trying to get pregnant, or you are unsure whether you are pregnant. When prescribed as an oral medication, tretinoin was associated with miscarriage and birth defects. While there is inconclusive evidence that tretinoin applied topically can cause miscarriage or birth defects, it is best to be cautious. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

How should I use tretinoin?
  • Unless directed otherwise by your provider, use the formula at nighttime before bed (UV light in sun degrades tretinoin). Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the medication. Apply a thin layer to the entire face. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.

  • Repeat 2–3 times a week as tolerated to begin with, then gradually increase to nightly use, or as directed by your provider.

  • Avoid exposure to the eyes, including eyelids, mouth, angles of the nose, and mucous membranes. If contact with the eyes occurs, rinse thoroughly with large amounts of water.

  • People using tretinoin should have an aggressive sun protection regimen including sunscreen (at least SPF 15 for daily wear and at least SPF 30 when spending time in direct sunlight), protective clothing, and sun avoidance whenever possible.

What should I tell my Ro Derm-affiliated provider before using tretinoin?
  • It’s important to tell your Ro Derm-affiliated provider all of the topical as well as oral medications you are currently using, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements, even if you think they are unrelated to the skin condition being treated.

Tretinoin can make your skin more sensitive to the sun and can cause drying and peeling.

  • Using tretinoin with other topical drying agents can increase the drying effects of tretinoin. Some topical medications to watch out for include salicylic acid, sulfur, and resorcinol

  • Some common oral medications that can make your skin more sensitive to the sun, including certain antibiotics and blood pressure medications, might exacerbate any sun sensitivity resulting from tretinoin use.

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:

  • Eczema

  • Sensitivity to the sun or are easily sunburned

  • Conditions that may increase sensitivity to sunlight. These include systemic lupus erythematosus, cutaneous lupus erythematosus, albinism, and porphyria

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I should monitor for when using tretinoin?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but may occur with tretinoin.

  • Skin discoloration

  • Inflammatory reaction with blistering

What are the most common side effects of tretinoin?

There may be some discomfort or peeling during the early days of treatment while your skin is adjusting to tretinoin. If side effects don’t subside within 2 to 4 weeks, or you are not seeing improvement, reach out to your Ro Derm-affiliated provider for guidance.

  • Dryness

  • Itching

  • Burning

  • Redness

  • Peeling

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.