Version May 2024
Acne vulgaris: Topical: Apply to acne lesions once daily before bedtime or in the evening. Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated. For moderate to severe acne, may be used as part of an appropriate combination regimen. Avoid simultaneous application with benzoyl peroxide (may reduce tretinoin efficacy) (Ref).
Palliation of fine wrinkles (Refissa/Renova), mottled hyperpigmentation, and tactile roughness of facial skin (Refissa): Topical: Apply a pea-sized amount of cream to entire face once daily in the evening or before bedtime.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing; safety/efficacy of Retin-A has not been established in patients >65 years of age; safety/efficacy of Refissa has not been established in patients >50 years of age; safety/efficacy of Renova has not been established in patients >71 years of age.
(For additional information see "Topical tretinoin (topical all-trans retinoic acid): Pediatric drug information")
Acne vulgaris: Children ≥8 years and Adolescents: Topical: Apply to affected areas once daily. Begin therapy with a weaker formulation of tretinoin and increase the concentration as tolerated; if stinging or irritation develop, decrease frequency of application. Approved ages varies by product; see individual product labeling. Guidelines suggest that topical retinoids may be used as part of a therapeutic regimen for all types and severity of acne in children and adolescents; however, specific data for each tretinoin product formulation may not be available (Ref).
Product specific:
Altreno (Lotion 0.05%): Children ≥9 years and Adolescents: Topical: Apply to affected areas once daily.
Atralin (Gel 0.05%): Children ≥10 years and Adolescents: Topical: Apply once daily to acne lesions before bedtime.
Retin-A (Cream 0.025%, 0.05%, or 0.1%; Gel 0.01% or 0.025%), Tretin-X (Cream 0.025%, 0.0375%, 0.05%, 0.075%, or 0.1%): Children ≥12 years and Adolescents: Topical: Apply once daily to acne lesions before bedtime or in the evening.
Retin-A Micro:
Children 8 to <12 years: Limited data available: Gel (0.04%): Topical: Apply once daily to acne lesions before bedtime or in the evening (Ref).
Children ≥12 years and Adolescents: Gel (0.04%, 0.06%, 0.08%, or 0.1%): Topical: Apply once daily to acne lesions before bedtime or in the evening.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however dosage adjustment unlikely needed due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however dosage adjustment unlikely needed due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Stinging of the skin (21%), local dryness (4% to 16%), hypopigmentation (≤12%)
Local: Application site erythema (2% to 51%), application site irritation (1% to 50%; severe: ≤3%), local skin exfoliation (1% to 49%), application site pruritus (2% to 35%), application site burning (8% to 30%), local desquamation (12%)
1% to 10%:
Dermatologic: Hyperpigmentation (≤2%)
Local: Application site dermatitis (4%), application site pain (1% to 3%)
Frequency not defined: Dermatologic: Skin photosensitivity
<1%, postmarketing, and/or case reports: Contact dermatitis, skin changes (atypical changes in melanocytes and keratinocytes, increased dermal elastosis; treatment lasting >48 weeks)
Hypersensitivity to tretinoin or any component of the formulation. Note: There are no contraindications listed in Altreno, Atralin, or Retin-A Micro US labeling.
Concerns related to adverse effects:
• Fish allergies: Atralin gel contains soluble fish proteins; use caution in patients with sensitivities or allergies to fish.
• Hypersensitivity reactions: Discontinue tretinoin if drug sensitivity, chemical irritation, or a systemic adverse reaction occurs.
• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid or minimize excessive exposure to sunlamps or sunlight. Daily sunscreen (SPF ≥15) use and other protective measures (eg, clothing over treated areas) are recommended. Use with caution in patients with personal or family history of skin cancer.
• Skin irritation: Treatment can increase skin sensitivity to weather extremes of wind or cold. Excessive dryness, redness, and swollen or blistered skin may occur. Also, concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be used with caution due to increased skin irritation. Depending on the severity of irritation, use a moisturizer, reduce the amount or frequency, or discontinue use until irritation disappears.
Disease-related concerns:
• Eczema: Use with caution in patients with eczema; may cause severe irritation.
Dosage form specific issues:
• Cream 0.02%: Do not use the 0.02% cream for longer than 52 weeks when using for palliation of fine wrinkles.
• Cream 0.05%: Do not use the 0.05% cream for longer than 48 weeks when using for palliation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin.
• Gel and Stieva-A cream [Canadian product]: Flammable; do not expose to high temperatures or flame.
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with abraded skin, sunburned skin, mucous membranes, eyes, mouth, angles of the nose. When used for palliation of fine wrinkles, mottled hyperpigmentation, or facial skin roughness, should be used as part of a comprehensive skin care and sun avoidance program.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Avita: 0.025% (20 g [DSC], 45 g [DSC])
Refissa: 0.05% (20 g [DSC], 40 g [DSC]) [contains edetate (edta) disodium, methylparaben, propylparaben]
Renova: 0.02% (20 g, 40 g, 60 g) [contains benzyl alcohol, cetyl alcohol, edetate (edta) disodium, methylparaben, propylparaben]
Renova Pump: 0.02% (44 g) [contains benzyl alcohol, cetyl alcohol, edetate (edta) disodium, methylparaben, propylparaben]
Retin-A: 0.025% (20 g, 45 g); 0.05% (20 g, 45 g); 0.1% (20 g, 45 g)
Generic: 0.025% (20 g, 45 g); 0.05% (20 g, 40 g [DSC], 45 g); 0.1% (20 g, 45 g)
Gel, External:
Atralin: 0.05% (45 g) [contains benzyl alcohol, butylparaben, ethylparaben, fish collagen hydrolyzates, isobutylparaben, methylparaben, propylparaben, trolamine (triethanolamine)]
Avita: 0.025% (20 g [DSC], 45 g [DSC])
Retin-A: 0.01% (15 g, 45 g); 0.025% (15 g, 45 g)
Retin-A Micro: 0.04% (20 g, 45 g); 0.1% (20 g, 45 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]
Retin-A Micro Pump: 0.04% (50 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]
Retin-A Micro Pump: 0.06% (50 g) [contains benzyl alcohol, edetate (edta) disodium, propylene glycol, trolamine (triethanolamine)]
Retin-A Micro Pump: 0.08% (50 g); 0.1% (50 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]
Generic: 0.01% (15 g, 45 g); 0.025% (15 g, 45 g); 0.04% (20 g, 45 g, 50 g); 0.05% (45 g); 0.08% (50 g); 0.1% (20 g, 45 g, 50 g)
Lotion, External:
Altreno: 0.05% (20 g, 45 g) [contains benzyl alcohol, methylparaben, trolamine (triethanolamine)]
May be product dependent
Cream (Renova External)
0.02% (per gram): $7.91
Cream (Renova Pump External)
0.02% (per gram): $7.60
Cream (Retin-A External)
0.025% (per gram): $0.90
0.05% (per gram): $0.90
0.1% (per gram): $1.20
Cream (Tretinoin External)
0.025% (per gram): $5.02 - $6.38
0.05% (per gram): $5.63 - $7.15
0.1% (per gram): $6.57 - $8.35
Gel (Atralin External)
0.05% (per gram): $15.00
Gel (Retin-A External)
0.01% (per gram): $1.20
0.025% (per gram): $1.20
Gel (Retin-A Micro External)
0.04% (per gram): $26.15
0.1% (per gram): $26.15
Gel (Retin-A Micro Pump External)
0.04% (per gram): $21.96
0.06% (per gram): $21.87
0.08% (per gram): $21.87
0.1% (per gram): $21.96
Gel (Tretinoin External)
0.01% (per gram): $5.32 - $6.75
0.025% (per gram): $5.36 - $6.81
0.05% (per gram): $7.50 - $9.52
Gel (Tretinoin Microsphere External)
0.04% (per gram): $15.00
0.08% (per gram): $19.66
0.1% (per gram): $15.00
Lotion (Altreno External)
0.05% (per gram): $3.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Retin-A: 0.01% ([DSC]); 0.025% ([DSC]); 0.05% (30 g); 0.1% ([DSC])
Generic: 0.01% (25 g); 0.025% ([DSC]); 0.05% ([DSC])
Gel, External:
Retin-A: 0.01% ([DSC]); 0.025% (30 g) [contains alcohol, usp]
Retin-A Micro: 0.04% (20 g, 45 g, 50 g); 0.1% (2 g, 20 g, 45 g, 50 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]
Generic: 0.01% (25 g); 0.025% (25 g); 0.05% (25 g)
For topical external use only; not for oral, ophthalmic, or intravaginal use. Prior to application, wash hands; gently wash face with a mild soap; pat dry and wait 20 to 30 minutes. Apply thin layer to affected area in the evening or before bedtime, avoiding eyes, ears, nostrils, and mouth. If stinging or irritation develop, temporarily discontinue or decrease frequency of application. Wash hands immediately after applying. Avoid use of products to the affected area that contain high concentrations of alcohol, astringents, or spices. Do not apply to sunburned skin. If combination topical therapy is required, consider separating applications (eg, one drug in the morning and the other in the evening or before bedtime).
Retin-A Micro: Avoid contact with lime peel and application area.
Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Prior to application, wash hands; gently wash face with a mild soap; pat dry and wait 20 to 30 minutes. Apply thin layer to affected area in the evening or before bedtime, avoiding eyes, mouth, paranasal creases, and mucous membranes. If stinging or irritation develop, temporarily discontinue or decrease frequency of application. Wash hands immediately after applying. Avoid use of products to the affected area that contain high concentrations of alcohol, astringents, or spices. Do not apply to sunburned skin. If combination topical therapy is required, consider separating applications (eg, one drug in the morning and the other in the evening or before bedtime).
Retin-A Micro: Avoid contact with lime peel and application area.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, administration, and disposal (NIOSH 2016). Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product; if there is potential for inhalation, respiratory protection is recommended (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
Acne vulgaris: Altreno, Atralin, Avita, Retin-A, Retin-A Micro, Stieva-A [Canadian product], Tretin-X, Vitamin-A Acid [Canadian product]: Treatment of acne vulgaris.
Palliation of fine wrinkles: Renova: Adjunctive treatment for mitigation (palliation) of fine wrinkles in patients who use comprehensive skin care and sun avoidance programs.
Palliation of fine wrinkles, mottled hyperpigmentation, and facial skin roughness: Refissa: Adjunctive treatment for mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone.
Tretinoin may be confused with ISOtretinoin, Tenormin, triamcinolone, trientine
Renova [U.S., Canada] may be confused with Remov brand name for nimesulide [Italy]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin A toxicity may rarely occur. Management: Avoid excessive intake of vitamin A (cod liver oil, halibut fish oil).
These products should not be used in women who are attempting to conceive or at high risk for pregnancy.
Adverse events were observed in some animal reproduction studies following topical application of tretinoin. Teratogenic effects were also observed in pregnant women following topical use; however, a causal association has not been established.
When treatment for acne is needed during pregnancy, other agents are preferred (Chien 2016; Kong 2013; Leachman 2006). These products should not be used in women who are pregnant.
It is not known if tretinoin is present in breast milk following topical application.
Tretinoin is an endogenous substance and likely present in breast milk. Although the manufacturer recommends caution when administering tretinoin (topical) to breastfeeding females, the use of topical agents is generally preferred over systemic agents for the treatment of facial acne in women who are breastfeeding; topical tretinoin may be compatible with breastfeeding; however, specific studies are not available. Avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption (Butler 2014; Kong 2013; Leechman 2006). Mothers should wash hands following application. Because topical agents can be transferred to a breastfeeding infant, avoid direct skin-to-skin contact with treated areas (Anderson 2018). Use of alternative agents or postponement of therapy may also be considered (Zip 2002). When used for other indications, treatment should be postponed until after breastfeeding is complete (Korgavkar 2015).
Tretinoin is a derivative of vitamin A. When used topically, it modifies epithelial growth and differentiation. In patients with acne, it decreases the cohesiveness of follicular epithelial cells and decreases microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
Onset of action: Acne: ≥2 weeks, may take ≥7 weeks; Facial wrinkles: Up to 6 months
Absorption: Minimal
Bioavailability: Avita cream and gel: <0.3%; Retin A Micro 0.1% gel: ~1%
Metabolism: Hepatic; forms metabolites
Excretion: Urine and feces
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