Refissa

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Refissa

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Refissa

Property Description
Active Ingredient Tretinoin (all-trans-retinoic acid)
Form Cream (Emollient Cream Base)
Pharmacological Class Retinoid (Vitamin A Derivative)
Common Use Adjunctive support for the appearance of facial skin
Origin Synthetic metabolite

Refissa is a prescription-only, single-active ingredient dermatological medicine formulated for topical use. Its active compound, Tretinoin, classifies it as a retinoid, a potent pharmacological class derived from Vitamin A. This means the product is a powerful synthetic derivative intended to exert specific, medically managed effects on the skin. Refissa is specifically known for its presentation as a moisturizing emollient cream, which differentiates its formulation approach from more drying gel or solution retinoids.

Tretinoin: Composition and Pharmaceutical Form

The core component of the Refissa formulation is the active ingredient Tretinoin (also known as all-trans-retinoic acid) at a concentration of 0.05%, delivered via an Emollient Cream Base. This preparation utilizes a specialized water-in-oil emulsion vehicle, which is a key characteristic of the product’s design. The emollient nature of the cream is structurally intended to provide conditioning support and minimize associated dryness during the topical application of the potent active ingredient, particularly for adult patients seeking support for facial skin concerns.

General Function and Action on the Skin

Refissa's general purpose is intrinsically linked to the ability of the retinoid compound to regulate fundamental cellular activity. Tretinoin works at a high level by promoting the acceleration of cellular renewal and normalizing the process of epithelial differentiation in the skin. Tretinoin is recognized for its ability to influence the structure of the skin and support dermal collagen formation. This demonstrates that its primary action is beneficial for promoting a smoother surface texture and a more uniform tone in the skin.

Regulatory References

  1. National Library of Medicine (NIH)
  2. DailyMed (NIH)

What side effects are possible with Refissa?

Possible Side Effects and Safety Information

The safety profile for Refissa (Tretinoin 0.05% Cream) is defined by predictable local adverse reactions and critical constraints, as documented in official regulatory labeling. The most frequently observed reactions affect the Skin and Subcutaneous Tissue system.


Frequency-Classified Adverse Reactions

Official prescribing information classifies the majority of local effects as Very Common or Common:

  • Very Common / Common: This includes erythema (redness), desquamation (peeling, flaking), dryness ( xerosis), pruritus (itching), and a burning or stinging sensation. These effects represent the skin's expected response to the retinoid compound.
  • Uncommon / Rare: More severe local manifestations, such as crusting or blistering, are reported less frequently.

Time-Related Patterns and Critical Safety Notes

Regulatory documents note that common local reactions are typically most intense during the initial few weeks of therapy (the acclimatization period) and tend to decrease with continued use.

Serious Adverse Reactions for topical use are primarily limited to severe local irritation requiring discontinuation and a critical population-specific constraint:

  • Absolute Contraindication in Pregnancy: Tretinoin is officially classified as a teratogen. Use is strictly prohibited during pregnancy and in individuals planning conception, establishing the most significant safety constraint for this medicine.

  • Phototoxicity: The official label mandates strict avoidance of excessive sunlight or artificial UV light (e.g., sunlamps). This is a required safety restriction due to the compound's documented ability to increase susceptibility to sunburn and phototoxicity.

Overdose and Emergency Response

The regulatory documentation for Refissa (Tretinoin cream) outlines specific manifestations and mandatory actions in the event of an overdose or accidental exposure.

Topical Over-application Manifestations

Excessive use of Refissa cream may result in documented localized skin reactions. These manifestations, listed in the official prescribing information, include marked redness, peeling (desquamation), and a general feeling of discomfort at the application site. Official labeling explicitly states that using an excessive amount of the cream will not produce more rapid or better clinical outcomes. The documented procedural measure for managing these localized effects is the temporary discontinuation of the application until the skin irritation subsides.

Systemic Overdose and When to Seek Urgent Help

The more serious scenario documented in the official regulatory profile is the accidental oral ingestion of the cream. In this systemic exposure context, the labeling warns that the resulting side effects may be comparable to those associated with excessive oral intake of Vitamin A (Hypervitaminosis A). Because of this potential for serious toxicity, the regulatory authorities mandate an immediate emergency response. When accidental ingestion is suspected, it is required that medical attention be sought immediately. Furthermore, the official emergency instructions require contacting emergency services or a national Poison Control center without delay. The prescribing information does not specify the existence of a known antidote for Tretinoin overdose.

Therapeutic Uses of Refissa

Refissa is generally applied in contexts involving the mitigation of visible signs of photoaging, or sun-damaged skin. This therapeutic application is relevant across three distinct symptom domains.

The medication is commonly used to help with fine facial lines, mottled hyperpigmentation, and tactile roughness of the facial skin. This benefit supports the patient during difficult episodes by easing the impact of the symptoms related to skin texture, especially when used within a comprehensive sun avoidance regimen.

“Refissa is applied in addressing symptomatic patterns characteristic of cumulative environmental damage.”

Symptom Domains and Benefits

Fine Facial Wrinkles: Refissa is applied in addressing the surface-level lines that develop from chronic sun exposure. This therapeutic approach contributes to improved day-to-day comfort during symptomatic periods, which supports general well-being.

Mottled Hyperpigmentation: The medication is relevant in clinical contexts where patients seek to manage sun-induced mottled hyperpigmentation—the irregular discoloration and patchy dark spots common with sun damage. It may assist with managing the symptoms related to systemic imbalance (irregular color), contributing to easing the overall symptom load.


Quick Fact: Symptomatic Management for Photoaging Signs

Refissa is generally applied when supportive symptom management is appropriate for visible signs of chronic sun exposure, such as irregular pigmentation and changes in skin texture, helping to maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. NIH DailyMed overview

Eligibility and Restrictions for Use

Refissa (tretinoin cream, USP 0.05%) has specific eligibility and non-eligibility rules established by regulatory authorities.

Contraindicated and Restricted Use

Refissa is strictly contraindicated for individuals with a history of sensitivity reactions (hypersensitivity) to any of its components.

Use is not recommended or is restricted for the following populations or conditions, as safety or effectiveness has not been established, or due to heightened risk:

  • Pregnancy and Lactation: Refissa should not be used by a patient who is pregnant or attempting to become pregnant. Caution should also be exercised when administering to a nursing mother.
  • Age: Safety and effectiveness have not been established in patients less than 18 years of age or in individuals older than 50 years of age.
  • Skin Type: Safety and effectiveness have not been established in individuals with moderately or heavily pigmented skin.
  • Skin Conditions: Use is discouraged until a patient is fully recovered from sunburn. Use requires utmost caution in patients with eczematous skin.
  • Photosensitizing Drugs: The drug should not be administered if the patient is taking other medications known to be photosensitizers (e.g., thiazides, tetracyclines), due to the possibility of augmented phototoxicity.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documentation for Refissa (Tretinoin topical) outlines two primary domains of interaction risk, focusing on managing compounded effects rather than systemic pharmacokinetic changes.

Formal Interaction Restrictions

Classification Interacting Agents Official Constraint
Contraindicated Combination Systemic Photosensitizing Drugs Formal prohibition of co-administration due to the risk of augmented phototoxicity. Examples include Thiazides, Tetracyclines, and Sulfonamides.
Use With Caution Topical Irritants and Drying Agents Requires careful management to avoid additive irritant effects (e.g., increased peeling or dryness).

Local Pharmacodynamic Interactions

Regulatory information specifies that concurrent use of several types of topical products can increase local irritation. These include other peeling agents, such as preparations containing sulfur, resorcinol, or salicylic acid. Products with high concentrations of alcohol or strong astringents are also cited for their potential to augment local side effects.

Procedural Interaction Notes

The label includes constraints related to timing and skin condition. The application of oxidizing agents, such as Benzoyl Peroxide, should be separated in time (e.g., morning/evening). Additionally, use is not recommended on sunburned skin until full recovery, and utmost caution is advised for patients with pre-existing eczematous skin due to a heightened risk of severe irritation.

Mechanism of Action

Refissa (Tretinoin) acts as a ligand for nuclear receptors, fundamentally operating as a gene modulator to influence the biological processes of skin cells.

Retinoic Acid Receptor (RAR) Nuclear Signaling

Tretinoin functions as an agonist for the mathbfRetinoic Acid Receptor (RAR) family, forming mathbfRAR/mathbfRXR heterodimers in the cell nucleus. When Tretinoin binds, it shifts them from transcriptional repressors to transcriptional activators, directly regulating target mathbfgene expression. This mechanism is receptor-mediated gene modulation, influencing cell behavior over time.

Epidermal Cell Turnover and Differentiation Modulation

The activated receptor complex upregulates genes that mathbfincrease the mitotic rate and mathbfaccelerate differentiation of keratinocytes. This mathbfspeeds up epidermal cell turnover, promoting the formation of a compact stratum corneum. This focus on cellular kinetics results in changes to the physical characteristics of the epidermal layer.

Dermal Matrix Synthesis and Catabolism Control

Tretinoin modulates mathbffibroblasts by mathbfupregulating the synthesis of mathbfCollagen Type I and III and mathbfElastin, while also mathbfdownregulating Matrix Metalloproteinases (MMPs). This regulation of the extracellular matrix balance leads to mathbfdermal thickening and influences the intrinsic physical properties of the skin.

Dosage and Administration Information

How to Use Refissa (Tretinoin Cream 0.05%)

The usage of Refissa is structured by the protocol defining the dose, frequency, and conditions for application.


Administration Scope and Protocol

Refissa is formulated exclusively for topical use on the face only. The official dosing schedule specifies that a pea-sized amount of the 0.05% cream should be applied once a day in the evening, before retiring. Applying more than the recommended amount is not advised, as it does not lead to better or faster results.

Instruction Detail
Route of administration Topical (cutaneous use on the face).
Dosing schedule A pea-sized amount once a day.
Frequency pattern Daily (once a day in the evening).
Use-context constraints Must be used as an adjunct to a comprehensive sun avoidance program.

Procedural Conditions and Duration

Specific steps must be followed immediately before and after application. The face must first be gently washed with a mild soap and patted dry. A 20 to 30 minute waiting period is required to ensure the skin is completely dry before application. It is also required that patients avoid applying any other product for at least one hour after Refissa has been spread lightly across the affected facial area, keeping the cream away from the eyes, nostrils, and mouth. The course of use is intended to be long-term; visible improvement may require up to six months of continuous daily therapy, and the safety and effectiveness of use beyond 48 weeks have not been established.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Refissa (tretinoin) is a retinoid cream primarily studied as an adjunctive agent for the mitigation of signs of photoaging, specifically fine facial wrinkles, mottled hyperpigmentation (spotty discoloration), and tactile roughness (rough feeling skin). It is intended for use alongside a comprehensive sun protection and skin care regimen.


Efficacy Studies

The effectiveness of Refissa 0.05% cream has been evaluated in double-blind, vehicle-controlled clinical trials, typically lasting 24 weeks, involving patients under the age of 50. These studies assessed changes from baseline in the appearance of photoaged skin using standardized rating scales.

  • Fine Wrinkles: In one analysis, a percentage of patients using Refissa combined with comprehensive skin care achieved moderate improvement (reduction of 2 or more units on a 10-point scale) in fine wrinkling, compared to a lower percentage in the vehicle-only group.
  • Hyperpigmentation: Study results similarly indicated that a higher percentage of patients using the tretinoin cream showed moderate improvement in mottled hyperpigmentation compared to those using the vehicle cream alone.

Improvement in these signs is often noted during the initial 24 weeks of therapy, and continued use primarily serves to maintain the initial effects realized.


Safety and Tolerability

Local skin reactions were commonly reported across almost all study subjects and generally occurred early in therapy. These included erythema (redness), peeling/scaling, dryness, burning, and stinging. These events were usually mild to moderate in severity. The safety and effectiveness of using the cream for longer than 48 weeks have not been definitively established in adequate and well-controlled trials. The effectiveness of Refissa has not been established in people over 50 years of age or in individuals with moderately to heavily pigmented skin.

Frequently Asked Questions (FAQ)

Common questions about Refissa (FAQ)

Q: What does 'topical' mean in relation to Refissa?

Refissa is a medication formulated for topical use, which simply means it is applied directly to the surface of the skin. Official documents specify that this cream is intended for application on the face only, differentiating it from medications meant to be swallowed or injected.

Q: Are there any non-skin uses for Refissa that people talk about?

According to the official product information, Refissa is indicated only as an adjunct for the mitigation of fine facial wrinkles, mottled hyperpigmentation (discoloration), and tactile roughness. The safety and effectiveness of using this product for any other conditions or disorders beyond its approved skin uses have not been established or evaluated.

Q: What are the most common reasons people stop using Refissa?

Regulatory documents indicate that local skin irritation, such as marked redness, peeling, or significant discomfort, may occur during the use of Refissa. If the intensity of this local irritation is severe enough, a healthcare provider may direct a patient to temporarily or permanently discontinue use of the cream.

Q: Is Refissa safe to use if I have sensitive skin?

Official warnings note that the skin of certain sensitive individuals may become excessively red, swollen, or blistered when using this medication. For individuals who may have highly sensitive skin, the official label notes that a healthcare provider may consider starting therapy at a reduced frequency or using a lower concentration formulation, to help manage potential irritation.

Q: Can I use Refissa with Vitamin C serums?

The official label advises caution when using Refissa alongside concomitant topical products, including medicated or abrasive soaps and cleansers, or cosmetics that have a strong drying or irritating effect. As certain serums may contain these types of agents, patients may wish to discuss all topical products, including specific serums, with their healthcare provider.

Q: Why do official documents warn about Refissa and waxing?

The official label includes a general warning to avoid certain types of products and procedures that can irritate the skin while using Refissa. This caution extends to harsh cleansers, hair removal methods like waxing, and other topical treatments that may increase skin sensitivity or irritation.

Q: What should I do if Refissa gets into my eyes?

Regulatory information mandates that special caution should be taken when applying the cream to avoid the sensitive areas of the eyes, mouth, corners of the nose, and mucous membranes. This is because Refissa may cause severe irritation if it comes into contact with these areas.

Q: Is Refissa available as a generic version?

Refissa contains the active ingredient tretinoin. Tretinoin itself is also widely available as a generic drug and is marketed under various other brand names, according to drug information databases.

Q: Does Refissa contain any fragrance or common allergens?

Official labeling lists the active ingredient, tretinoin, and a variety of inactive ingredients (excipients), such as butylated hydroxytoluene, sorbic acid, and stearyl alcohol. The full list of inactive ingredients is available on the product label for review with a healthcare provider, particularly concerning potential allergens or irritants.

Q: Are there different brand names for the same active ingredient as Refissa?

Yes. The active ingredient in Refissa is tretinoin (all-trans-retinoic acid). This compound is used in several different prescription medications, meaning it is available under multiple brand names in addition to its generic form.

Q: What are the official guidelines regarding discontinuing use of Refissa?

Official guidelines state that if a patient experiences a reaction suggesting sensitivity or chemical irritation, use of the product should be discontinued. Patients may also be instructed to temporarily stop use if the local irritation is severe, resuming therapy when their skin can better tolerate the treatment.

Q: Can Refissa cause headaches?

The most common adverse reactions reported in official documents are local skin reactions affecting the application site, such as redness, peeling, and dryness. Systemic effects like headaches are not listed as common side effects for topical application.

Q: Does Refissa cause any systemic side effects?

According to official documentation, the most frequently reported adverse reactions are limited to the application site (skin and subcutaneous tissue). While the oral form of the active ingredient may lead to systemic effects, these are not typically reported for the topical cream when used as directed.

Q: Why do doctors often start patients on a lower concentration of Refissa?

Official product information notes that using lower concentrations or applying the medication less frequently can help limit the potential for skin irritation. This approach is often taken by healthcare providers, particularly for sensitive skin, to help patients acclimatize to the treatment.

Q: Is it safe to get a chemical peel while using Refissa?

The product label advises particular caution regarding the use of preparations containing peeling agents, such as sulfur, resorcinol, or salicylic acid. Official guidelines recommend that the skin be allowed to 'rest' until the effects of such preparations subside before using Refissa.

Q: Can Refissa interact with non-sunscreen facial cosmetics?

Patients are generally permitted to use cosmetics after applying the cream, but regulatory documents advise that the treated areas should be thoroughly cleansed before the medication is applied. It is also advised to avoid applying any other topical products for at least one hour after the application of Refissa.

Q: Why is Refissa prescribed for certain skin conditions?

The active ingredient in Refissa functions as a gene modulator that influences the biological processes of skin cells, leading to accelerated cell turnover and support for dermal collagen formation. Regulatory studies confirm that this mechanism supports the mitigation of fine facial wrinkles, hyperpigmentation, and tactile roughness, which is why it is prescribed for these signs of photoaging.

Q: Is Refissa used for acne or primarily for wrinkles?

Clinical studies and official indications for Refissa 0.05% cream focus on its role as an adjunctive agent for the mitigation of signs of photoaging, specifically fine facial wrinkles, mottled hyperpigmentation, and tactile roughness. The label does not indicate its use for the treatment of acne.

Q: Does Refissa thin the skin over time?

The active ingredient in Refissa works by promoting dermal matrix synthesis, which helps in dermal thickening—the opposite of thinning. Official research indicates that this mechanism influences skin structure and supports collagen formation.

Q: Is it normal to see worsening of the skin condition right after starting Refissa?

Official documentation notes that local reactions, such as redness and peeling, are typically most intense during the initial few weeks of therapy (the acclimatization period). These effects are the skin’s expected response to the retinoid and tend to decrease with continued use.

Q: Can Refissa cause changes in skin color?

Yes, Refissa has been studied for its effectiveness in improving mottled hyperpigmentation (spotty discoloration). Additionally, erythema (redness) is a common, expected side effect of the cream, particularly during the initial weeks of use.

Q: Are there any over-the-counter creams that interact with Refissa?

Official constraints advise caution regarding other topical products, especially those that act as irritants or drying agents. This includes OTC preparations containing high concentrations of alcohol, sulfur, resorcinol, or salicylic acid, as concurrent use can lead to additive irritant effects like increased peeling or dryness.

Q: What is the shelf life of a tube of Refissa?

Official guidelines do not specify a general 'shelf life' after opening, but they mandate that the medication be stored in the original container, tightly closed, and not be kept past its expiration date. The expiration date is found on the product’s packaging.

Q: Does the vehicle (cream, gel, etc.) of Refissa make a difference?

Yes. Refissa is formulated as an Emollient Cream Base, which utilizes a specialized water-in-oil emulsion vehicle. This preparation is structurally intended to provide conditioning support and minimize associated dryness during topical application of the active ingredient, differentiating its approach from more drying gel or solution retinoids.

Q: Can I use Refissa if I am taking an oral antibiotic?

Regulatory information includes a formal prohibition against co-administration with systemic photosensitizing drugs, which include classes like Tetracyclines and Sulfonamides. Patients may wish to consult with a healthcare provider regarding the use of oral antibiotics, as certain classes are formally prohibited from co-administration due to the risk of augmented phototoxicity.

Q: Why is nighttime application usually recommended for Refissa?

The official label mandates strict avoidance of excessive sunlight and artificial UV light because the medication increases susceptibility to sunburn and phototoxicity. Therefore, application once a day in the evening, before retiring, is recommended to minimize sun exposure and the potential for skin reactions.

Q: Can Refissa permanently reverse wrinkles?

Refissa is studied as an adjunctive agent for the mitigation of signs of photoaging, such as fine facial wrinkles. Clinical evidence suggests that continued use primarily serves to maintain the initial improvements realized, emphasizing its role in supporting the long-term appearance of the skin rather than a permanent reversal.

Q: Can I use moisturizers after applying Refissa?

The official protocol advises a necessary 20 to 30 minute waiting period to ensure the skin is completely dry, and it is required that patients avoid applying any other product for at least one hour after Refissa has been spread. A moisturizer may typically be used after this mandated one-hour period has passed.

Q: Why is sunscreen so important when using Refissa?

Sun protection is essential because the active ingredient is documented to increase the skin's susceptibility to sunburn and phototoxicity. Official documentation mandates that Refissa must be used as an adjunct to a comprehensive sun avoidance program.

Q: Is the redness I feel from Refissa a sign of an allergic reaction?

Redness (erythema) is classified in regulatory documents as a Very Common or Common local adverse reaction, representing the skin's expected response to the retinoid compound. However, use is strictly contraindicated if a patient has a history of sensitivity reactions (hypersensitivity) to any of its components.

How should Refissa be stored and disposed of?

How to Store and Dispose of Refissa?

The storage and disposal of Refissa (Tretinoin Cream 0.05%) must strictly follow official regulatory guidelines to maintain its stability and ensure safety.

Mandatory Storage Conditions

Requirement Rule
Temperature Store at 20^circ to 25^circC (68^circ to 77^circF) (Controlled Room Temperature).
Protection Protect from freezing, and store away from excess heat, moisture, and direct light.
Container Keep the medication in the original container, tightly closed.

Safety and Disposal Protocol

Official labeling mandates that Refissa be stored out of the reach of children. The product should not be kept past its expiration date. Regarding disposal, users must consult a healthcare professional on how to discard any unused or outdated medicine, in accordance with local environmental regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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