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FDA-Approved Use

Tretinoin gel, USP (microsphere) 0.1% and 0.04% are  FDA-Approved for topical application in the treatment of acne vulgaris.

In addition, tretinoin has been studied for the promotion of hair growth, especially in combination with 0.5% minoxidil, showing promising results in subjects with androgenetic alopecia. The combination of topical tretinoin with 0.5% minoxidil has demonstrated terminal hair regrowth in a significant percentage of subjects.


Mechanism of Action 

The exact mechanism of action of tretinoin remains unknown. Existing evidence indicates that when applied topically, tretinoin reduces the adhesion between follicular epithelial cells, potentially reducing the formation of microcomedones. Moreover, it appears to enhance cell division and accelerates the turnover of these cells in hair follicles, leading to the expulsion of comedones.


Who should not use tretinoin?

Do not use tretinoin if: 

  • You are allergic to tretinoin or any other ingredients in your prescription solution. Consult your pharmacist for a list of ingredients.
  • You have or have ever had eczema (a skin disease), actinic keratoses (scaly spots or patches on the top layer of the skin), skin cancer, or other skin conditions.


What should I tell a provider before starting tretinoin?

Ensure you disclose your entire medical history to your healthcare provider.  Be aware that withholding or providing inaccurate health and medical history to obtain treatment can have serious consequences, potentially including death.

  • Comorbidities:
    • Actinic keratoses (scaly spots or patches on the top layer of the skin)
    • Skin cancer or other skin conditions
    • Extreme caution is advised in individuals with eczema, as tretinoin may cause severe irritation. Discontinue use if sensitivity or chemical irritation occurs.
  • Pregnancy and Special Populations:
    • Tretinoin is pregnancy category C, indicating that its safety in pregnant women has not been fully established. Avoid use unless deemed essential by a physician.
    • The safety and efficacy of topical tretinoin products have not been established in children and adolescents. Children should not take or come in contact with tretinoin.
  • Drug-Interactions:
    • Tretinoin may interact with certain medications, and it is vital to inform your healthcare provider of all medications you are currently taking. 
    • Avoid using tretinoin with other topical medications such as abrasive soaps, cleansers, or cosmetics with strong drying effects, as they may increase skin irritation.
    • Benzoyl Peroxide Topical & Salicylic Acid Topical: Use cautiously to avoid increased skin irritation. Seek guidance from your healthcare provider.
    • Isotretinoin: Be aware of additive effects. Consult your healthcare provider for suitable use.
    • Consult your provider if you are using any of the following: aminolevulinic acid, clascoterone topical, isotretinoin, methoxsalen, methyl aminolevulinate topical, porfimer, resorcinol topical, sulfur topical, verteporfin.


How should I use tretinoin?

If applying any form of tretinoin, follow these steps:

  • Wash hands and affected skin thoroughly with mild soap and water.
  • Ensure the skin is dry before applying tretinoin.
  • Use clean fingertips to apply a thin layer of the medication to the affected area only.
  • Avoid contact with eyes, ears, mouth, corners along the nose, or the vaginal area.
  • Do not apply on areas of sunburn.


What side effects should I be aware of with tretinoin?

Common side effects for topical tretinoin:

  • Warmth or slight stinging of the skin.
  • Lightening or darkening of the skin.
  • Red, scaling skin.
  • Increase in acne sores.
  • Swelling, blistering, or crusting of the skin.
  • Dryness, pain, burning, stinging, peeling, redness, or flaky skin at the treatment area.


Serious side effects of tretinoin:

You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes. If you experience severe symptoms or are having a medical emergency, call 911 or seek immediate medical attention.

  • Itching: If you develop persistent itching.
  • Hives: If you notice the onset of hives.
  • Pain or discomfort at the treatment area: Report any significant pain or discomfort.


The above does not encompass all potential side effects, medication interactions, or studies related to tretinoin. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of tretinoin.

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