Important Safety Information — Tretinoin (Topical)

Indications

Topical tretinoin (retinoic acid) is a retinoid indicated for the topical treatment of acne vulgaris and to improve the appearance of fine wrinkles, mottled hyperpigmentation, and roughness of facial skin associated with photodamage. It works by promoting skin cell turnover and stimulating collagen production.

Contraindications

• Known hypersensitivity to tretinoin or any component of the formulation
• Do not use on sunburned skin
• Do not use on skin affected by eczema
• Do not use on open wounds or broken skin

Warnings and Precautions

• Sun sensitivity (photosensitivity): Tretinoin significantly increases the skin's sensitivity to ultraviolet (UV) light. Use a broad-spectrum sunscreen of SPF 15 or higher daily, and wear protective clothing. Minimize sun exposure, including tanning beds and sunlamps. The intensity of the inflammatory skin reaction may increase with UV exposure.
• Initial skin irritation: During the first 2-4 weeks of treatment, the skin may become red, dry, itchy, or peel. An apparent exacerbation of acne may occur during the first weeks of treatment as tretinoin works on pre-existing microcomedones. This usually subsides with continued use.
• Wind and cold exposure: Skin treated with tretinoin may be more vulnerable to wind and cold weather, which can exacerbate dryness and irritation.
• Flammability: Gel formulations are flammable. Avoid exposure to fire, flame, or smoking during and immediately following application.
• Topical only: For external use only. Do not take by mouth. Avoid contact with the eyes, ears, nostrils, and mouth.
• Avoid harsh products: Use with caution in combination with other potentially irritating topical products (medicated or abrasive soaps, cleansers with drying effects, products with high concentrations of alcohol, astringents, or spices).

Common Side Effects

• Skin dryness and peeling
• Redness (erythema)
• Burning or stinging sensation
• Itching (pruritus)
• Skin warmth
• Temporary darkening or lightening of treated skin
• Initial worsening of acne (first 2-4 weeks)

Serious Side Effects

Discontinue use and seek medical attention if you experience any of the following:

• Severe skin irritation: blistering, crusting, severe burning, or swelling
• Signs of allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat
• Severe sunburn on treated areas
• Persistent skin discoloration

Drug Interactions

• Benzoyl peroxide: May cause severe skin irritation when used simultaneously. If both are prescribed, apply at different times of day (e.g., tretinoin at night, benzoyl peroxide in the morning).
• Sulfur, resorcinol, or salicylic acid: Concomitant topical use may cause severe skin irritation. Do not use unless directed by your provider.
• Alcohol-containing topical products: Products with high alcohol content, menthol, spices, or lime may cause additional irritation and stinging.
• Vitamin A supplements: Oral vitamin A may increase the risk of tretinoin-related side effects. Inform your provider of all supplements.
• Photosensitizing medications: Concurrent use with other photosensitizing drugs (e.g., thiazide diuretics, tetracyclines, fluoroquinolones, sulfonamides) may increase the risk of sunburn.
• Other topical retinoids: Do not use simultaneously with other retinoid products.

Use in Specific Populations

• Pregnancy: Topical tretinoin should be avoided during pregnancy. While systemic absorption from topical application is minimal, oral retinoids are known teratogens. Consult your healthcare provider.
• Lactation: It is not known whether topical tretinoin is excreted in human breast milk. Use with caution during breastfeeding.
• Pediatric use: Safety and effectiveness in children under 12 years of age have not been established.
• Geriatric use: No specific dose adjustments required. Older adults may experience more pronounced skin dryness and should moisturize adequately.