Arazlo

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Arazlo

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Arazlo

Quick Facts

Property Description
Active ingredient Tazarotene
Form Lotion
Pharmacological class Retinoid (Third-generation topical)
General purpose Normalizes skin cell differentiation
Origin Synthetic (Acetylenic)

What Type of Medicine is Arazlo and What is its Composition?

Arazlo is a prescription medicine intended for topical use on the skin, supplied as a white to off-white 0.045% lotion. This aqueous formulation is designed as a non-greasy vehicle for effective delivery of the active component to the skin's surface. The sole active ingredient is Tazarotene, a chemically manufactured, synthetic substance belonging to the acetylenic class of retinoids. The specific lotion formulation of Arazlo is clinically recognized for its high spreadability and non-greasy feel, differentiating it from traditional retinoid creams and gels.

Arazlo's Place in Pharmacological Classification

Tazarotene is classified pharmacologically as a retinoid, which are compounds structurally related to Vitamin A. A key property is that Tazarotene functions as a prodrug; the molecule applied to the skin must undergo an internal conversion process known as esterase hydrolysis to become its therapeutically active metabolite, Tazarotenic acid. The active metabolite selectively binds to specific retinoic acid receptors (RAR-beta and RAR-gamma). This targeted action is fundamental to its mechanism, with research confirming the selective receptor binding profile of Tazarotenic acid. This selective binding profile indicates a precise engagement with the cellular pathways responsible for regulating skin health.

What is the General Therapeutic Purpose of Arazlo?

The fundamental purpose of Arazlo is to address underlying cellular issues in the skin by promoting two primary physiological actions: the normalization of epidermal cellular differentiation and the provision of an anti-inflammatory effect. By helping skin cells mature and function appropriately, the medicine works to correct the irregular skin cell life cycle. This effect is useful in dermatological conditions characterized by abnormal cellular turnover, such as the typical presentation of acne vulgaris. The overall benefit is the comprehensive restoration of healthy skin function and a reduction in the visible signs associated with the targeted dermatological condition.

What side effects are possible with Arazlo?

Possible side effects and safety information

The safety profile of Arazlo (tazarotene 0.045% lotion) is primarily defined by localized skin reactions and important restrictions concerning its use in certain populations, as documented in regulatory labeling.

Common Adverse Reactions

The most commonly reported adverse reactions are local effects confined to the application site, classified as Common (occurring in ge 1% of patients) in official prescribing information. These effects typically involve localized skin and subcutaneous tissue disorders.

Adverse Reaction Type Classification (Regulatory)
Application Site Pain Common (ge 1%)
Application Site Pruritus (Itching) Common (ge 1%)
Application Site Erythema (Redness) Common (ge 1%)
Application Site Exfoliation (Peeling) Common (ge 1%)
Application Site Dryness and Irritation Common (ge 1%)

These localized reactions are often most prominent and occur more frequently early in the course of treatment and may lessen over time, according to regulatory safety notes.

Key Safety Constraints and Restrictions

The most significant safety constraint is the contraindication during pregnancy. As a retinoid, systemic exposure to tazarotene can pose a risk of embryo-fetal toxicity, and use is restricted in females who are pregnant or are planning to become pregnant.

Another significant restriction noted in official labeling is the risk of photosensitivity. The medicine may increase susceptibility to UV light, including sunlight and sunlamps. Additionally, concurrent use with other topical products that are abrasive or highly drying may result in additive skin irritation. Safety and effectiveness are established for the treatment of acne in pediatric patients aged nine years and older.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory information for Arazlo addresses overdose based on the exposure route, distinguishing between local effects and systemic risk.

Manifestations and Actions for Overuse

Excessive topical application of the lotion may lead to exaggerated skin reactions, specifically marked redness, excessive peeling, and severe local irritation. If such severe local manifestations occur, the application should be temporarily discontinued or reduced to allow for the recovery of skin integrity.

Systemic Risk and Required Emergency Action

Accidental oral ingestion of the medicine presents the risk of systemic toxicity and requires immediate attention. Ingestion carries the potential for symptoms associated with hypervitaminosis A or other forms of retinoid toxicity. For any accidental oral ingestion, immediate medical help must be sought by calling the Poison Control Center right away. In the event of severe, life-threatening signs, such as passing out or trouble breathing, emergency services (911) should be contacted.

Management and Specific Considerations

Management of Tazarotene overdose is officially defined as symptomatic and supportive, as no specific antidote is known. Hospital monitoring may be required following accidental oral ingestion, especially when there is a potential for significant systemic exposure. A specific risk noted in regulatory documents is the potential for embryofetal toxicity for females of reproductive potential should significant systemic exposure occur.

Therapeutic Uses of Arazlo

What Arazlo Treats: Main Uses and Benefits

Arazlo (tazarotene 0.045% lotion) is relevant for easing symptoms related to the chronic skin condition, acne vulgaris, by addressing core symptomatic presentations. The tazarotene class is applied across domains where additional symptomatic support is needed.


The medication is commonly used across conditions characterized by periods of heightened symptoms related to chronic, recurring skin lesions. Relevant when supportive symptom management is appropriate, Arazlo helps address symptom clusters that may become intense or disruptive, specifically inflammatory lesions (papules and pustules) and non-inflammatory lesions (blackheads and whiteheads). This provides support that helps ease the overall symptom burden.

Arazlo is commonly used in situations involving certain distressing symptoms, particularly for acne presenting in the moderate severity range in both adolescent (aged 9 and older) and adult patients. This supportive relief assists with maintaining functional stability when symptoms are more noticeable.

Quick Fact: Relief Context
Symptom Domains Symptoms related to inflammatory or irritative states and follicular blockages
Targeted Severity Commonly used for moderate severity acne manifestations
Patient Focus Adolescents (≥ 9 years) and adults managing chronic acne

Eligibility and Restrictions for Use

Who Can and Cannot Use Arazlo?

The eligibility for using Arazlo (tazarotene 0.045% lotion) is defined by specific regulatory requirements, primarily focused on age, reproductive status, and the condition of the skin. The information below is strictly based on official government labeling.

Eligibility and Contraindications

Category Eligibility Rule
Approved Use Indicated for patients 9 years of age and older.
Absolute Contraindication Pregnancy is an absolute contraindication due to the risk of fetal harm.
Conditional Use Females of childbearing potential must obtain a negative pregnancy test prior to starting treatment and use effective contraception during therapy.
Avoidance Required Application must be avoided on sunburned skin until fully recovered and on eczematous skin, as this may cause severe irritation.

Age and Physiological Limitations

Safety and effectiveness have not been established in pediatric patients younger than 9 years of age. Furthermore, use in the geriatric population (65 years and older) is also considered not established due to insufficient data from appropriate studies.

Regarding lactation, it is not known if the drug is excreted in human milk; therefore, a decision must be made to either discontinue breastfeeding or discontinue the drug while considering the mother’s health. Specific contraindications or adjustments for hepatic or renal impairment are not documented in the official labeling.

What should I know about interactions with other medicines?

The official regulatory profile for Arazlo (tazarotene) is structured predominantly around local pharmacodynamic effects and chemical incompatibility, as no formal drug-drug interaction studies were conducted to assess systemic pharmacokinetic interactions. Consequently, no metabolic or exposure-modifying interactions with systemic medicines are officially documented.

Pharmacodynamic Augmentation

Co-administration with systemic photosensitizing agents may lead to an increased possibility of augmented photosensitivity and risk of severe sunburn. This category includes drug classes such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides. Additionally, a cumulative irritant effect on the skin may occur with the co-use of other topical preparations that have a strong drying or abrasive effect, such as medicated soaps or astringents.

Chemical Incompatibility and Timing Restriction

A significant interaction is documented with oxidizing topical agents, including Benzoyl Peroxide. This chemical incompatibility may cause the degradation of tazarotene and potentially reduce its clinical efficacy. To manage this effect, regulatory labeling requires that Arazlo and any oxidizing agent be applied at different times of the day (e.g., separating administration to morning and evening) to prevent chemical neutralization. The overall structure is limited to label-based constraints and warnings for local risks.

Mechanism of Action

Arazlo (tazarotene) functions as a retinoid prodrug that is hydrolyzed in the tissue to its active metabolite, tazarotenic acid. This active form operates as a receptor agonist within the cell nucleus, exhibiting binding affinity for all three human Retinoic Acid Receptors (RARs): RARalpha, RARbeta, and RARgamma. Tazarotenic acid demonstrates relative selectivity for RARbeta and RARgamma.

The binding of tazarotenic acid to the nuclear RARs modulates gene transcription by interacting with Retinoic Acid Response Elements (RAREs) on the DNA. This action modifies the expression of multiple target genes, including the upregulation of the Tazarotene-Induced Genes (TIGs), specifically TIG-1, TIG-2, and TIG-3. Downstream consequences involve a reduction in keratinocyte hyperproliferation and a normalization of cellular differentiation patterns in the epidermis. System-level physiological modulation includes changes in overall keratinocyte kinetics and a molecular downregulation of various inflammatory markers in the targeted tissue.

Dosage and Administration Information

How to Use Arazlo

This section outlines the general principles for the administration of Arazlo (0.045% tazarotene lotion), detailing the required route, frequency, and population-specific rules for its application.


Official Administration Guidelines

The formulation is for topical use on the skin and must not be administered orally, ophthalmically, or intravaginally. The standard regimen involves applying a thin layer of the lotion once daily (QD) to the affected areas of the face and/or trunk.

Classification Administration Principle
Route of Administration Topical use only
Frequency Pattern Once daily (QD)
Age Group Approved for patients 9 years of age and older

Administration Constraints and Adjustments

Use of Arazlo requires adherence to specific anatomical constraints: the lotion must be applied only to the targeted areas and is to be avoided on the eyes, mouth, paranasal creases, and mucous membranes. Following application, hands must be washed thoroughly.

When co-administering with other topical oxidizing agents, such as benzoyl peroxide, the products are applied at different times of the day to prevent potential issues from simultaneous application. Furthermore, the treatment protocol specifies that the application frequency may be reduced or temporarily interrupted if excessive irritation develops, with the resumption of the once-daily application being governed by the patient's ability to tolerate the product.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Arazlo

This overview summarizes the formal clinical research that has been conducted for Arazlo (tazarotene 0.045% lotion), describing the types of studies, the outcomes they measured, and what remains to be fully characterized, according to official regulatory and scientific sources.


Evidence for Use in Facial Acne Vulgaris

The main evidence base for Arazlo is derived from two large, short-term randomized, double-blind, vehicle-controlled trials (RCTs) involving over 1,600 subjects. These types of studies are recognized as primary research for regulatory evaluation. These studies were conducted in research scenarios exploring how symptoms change over time in patients with facial acne, specifically focusing on those with a moderate-to-severe manifestation of the condition. Researchers monitored specific outcomes, including the absolute counts of both inflammatory lesions (papules and pustules) and non-inflammatory lesions (blackheads and whiteheads) over a 12-week period.

The studies evaluated the co-primary endpoints, which included the measurements of lesion counts and the proportion of subjects achieving a score of "clear" or "almost clear" in comparison to the vehicle (placebo) group. Research also examined patient-reported experiences, where participants filled out surveys related to how acne affects their daily functioning and quality of life. Findings describe patterns observed in these patient-reported outcomes, contributing to a broader understanding of symptom patterns over the defined time interval.

Evidence for Use in Truncal (Body) Acne Vulgaris

Research exploring the application of Arazlo for truncal (body) acne vulgaris is based on a separate, much smaller set of data. This evidence comes from a single, short-term (12-week duration) open-label study that was observed in only 24 patients, which means the study did not use a controlled comparison group (such as a vehicle or placebo) and was not blinded.

Due to the modest sample size and the open-label design, the evidence quality varies across studies, and this evidence base remains limited. Studies monitored the physiological strain or stress of the skin by measuring overall change using an Investigator's Global Assessment (IGA) scale for truncal acne. Findings from this small cohort contribute to the broader evidence landscape, but are not derived from controlled research.


Duration of Evidence and Long-Term Follow-up

The primary registration evidence for Arazlo is confined to the 12-week follow-up durations of the trials. This means that the research provides insight into short-term changes observed over the 12-week period.

Long-term effects are not fully established for the specific 0.045% lotion formulation. Data for maintenance or durability of the effect beyond this 12-week period are currently insufficient. Any insights into longer-term outcomes are derived from post-marketing reviews or research conducted using other formulations within the tazarotene class of medicines.

What Remains Under Research and Uncertain

The research base has several acknowledged limitations, which helps define what is still uncertain about the evidence for Arazlo:

  • Long-term effects are not fully established. The follow-up durations were limited to 12 weeks in the main efficacy studies, meaning there is limited information for long-term outcomes.
  • The research focuses narrowly on severity. Because the pivotal trials studied only moderate-to-severe acne, data for certain groups remain insufficient for patients with a milder presentation of the condition.
  • Evidence quality varies across studies. The evidence was evaluated for truncal acne based on a small, non-controlled study, and certainty remains low for this specific application.

Key Studies & References Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials (NCT02933758 and NCT02933771)

Frequently Asked Questions (FAQ)

Common questions about Arazlo (FAQ)


Q: How quickly does Arazlo start showing results?

Clinical trials for Arazlo, according to official information, were conducted over a 12-week period. The product's effectiveness was determined by changes observed at the end of the 12th week of treatment. While research provides insight into symptom patterns over this duration, official documents do not typically establish the earliest exact time point when individual users may see initial results.


Q: What is the difference between Arazlo and other topical retinoids?

Arazlo contains the active ingredient tazarotene, which is a specific type of synthetic retinoid. The active component is described as selectively engaging with certain receptors in the skin. A key physical differentiator is that Arazlo is a 0.045% lotion formulation, whereas other retinoids may be available in different strengths, creams, or gels.


Q: Can Arazlo be used for wrinkles or anti-aging?

According to the U.S. Food and Drug Administration (FDA) regulatory documents, Arazlo is formally indicated only for the topical treatment of acne vulgaris in patients 9 years of age and older. Its approved purpose does not include the treatment of wrinkles, fine lines, or other signs of aging.


Q: Is it normal to have some irritation when first starting Arazlo?

Localized skin reactions are documented as the most common side effects of Arazlo, occurring in ge 1% of patients. These can include pain, dryness, peeling, redness, or itching at the application site. Regulatory notes indicate these reactions are often most frequent and prominent early in the course of treatment, with observations suggesting they may diminish over time.


Q: Does Arazlo interact with oral antibiotics for acne?

No formal studies were conducted to assess systemic interactions between Arazlo and oral medicines. However, official regulatory information notes that using Arazlo alongside systemic photosensitizing agents, such as certain classes of antibiotics (e.g., tetracyclines, fluoroquinolones), may lead to an increased possibility of augmented sensitivity to the sun.


Q: Is Arazlo safe to use during the summer?

Arazlo may increase the skin's susceptibility to UV light, including sunlight and sunlamps. Official labeling states that users should minimize unprotected exposure to the sun. Protective measures such as the regular use of sunscreen and appropriate clothing over treated areas are necessary when sun exposure cannot be avoided.


Q: What are people's experiences with using Arazlo for mild versus severe acne?

The main efficacy trials supporting the approval of Arazlo focused on patients presenting with moderate-to-severe facial acne vulgaris. The evidence base used for official review is considered insufficient to characterize the effect in patients with a milder presentation of the condition.


Q: What is the purpose of the lotion vehicle in Arazlo?

Arazlo is formulated as an aqueous 0.045% lotion designed for effective delivery of the tazarotene active ingredient. The lotion vehicle is generally recognized in official descriptions for properties such as high spreadability and a non-greasy cosmetic feel, and its composition is generally regarded as having hydrating properties.


Q: Is Arazlo the same as Tazorac?

Arazlo and Tazorac are both prescription medicines that contain the same active ingredient, tazarotene. However, they are different brand-name products. Arazlo is a 0.045% lotion formulation, while Tazorac is available in different strengths and forms, such as creams or gels.


Q: Can I use Arazlo if I have sensitive skin?

Arazlo is commonly associated with local reactions like dryness, redness, and irritation. Regulatory labeling specifically warns that the product should not be applied to sunburned skin or skin with eczema due to the potential for severe irritation. Official documents do not specifically address use on general sensitive skin types.


Q: Is it okay to use moisturizer with Arazlo?

Official regulatory warnings advise avoiding the co-use of other topical preparations that have a strong drying or abrasive effect to prevent cumulative irritation. General moisturizing products are not typically categorized as abrasive or drying agents. Note that official labeling for other topical products advises separating the application time.


Q: Can men use Arazlo?

Arazlo is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Official information does not specify any gender restrictions or limitations on use for men.


Q: Is there a generic version of Arazlo?

Arazlo is the brand name for the tazarotene 0.045% lotion formulation. Tazarotene is the generic name of the active ingredient, which is available in other formulations and strengths under different brand names and as generic topical tazarotene preparations.


Q: Will Arazlo clear up blackheads and whiteheads?

Clinical trials for Arazlo measured its effect by reducing both inflammatory lesions (such as papules and pustules) and non-inflammatory lesions (such as blackheads and whiteheads). These measurements contributed to the evidence base for its approval in treating acne vulgaris.


Q: Are there different formulations or strengths of Arazlo available?

Arazlo is currently available as a single formulation: the 0.045% tazarotene lotion. Other forms and strengths of the active ingredient tazarotene are available under different product names.


Q: Can I use other types of skin care acids (like AHAs or BHAs) while on Arazlo?

Regulatory documents advise general caution regarding the co-use of other topical preparations that have a strong drying or abrasive effect. This is a broad restriction intended to prevent cumulative skin irritation when using multiple products.


Q: Can Arazlo help with acne scarring?

Arazlo is officially indicated only for the topical treatment of active acne vulgaris lesions. Its approved purpose does not include the treatment or reduction of existing acne scarring.


Q: Can Arazlo be used on parts of the body other than the face?

Official administration guidelines state the lotion should be applied to the affected areas of the face and/or trunk. Clinical studies supporting the product's use include evidence gathered from patients with truncal (body) acne vulgaris.


Q: How long does the initial dryness or peeling usually last with Arazlo?

Localized reactions like dryness and peeling are often observed to be most prominent early in the course of treatment, according to official labeling. The official product information does not provide a specific timeline for when these initial symptoms will resolve for every individual patient.


Q: What kind of studies were done to approve Arazlo?

The regulatory approval was primarily supported by two large, short-term randomized, double-blind, vehicle-controlled clinical trials. These studies compared Arazlo’s effect against a non-active lotion vehicle (placebo) in patients with moderate-to-severe facial acne.


Q: Are the long-term effects of using Arazlo known?

The primary clinical evidence used for the regulatory review of Arazlo is confined to the 12-week follow-up durations of the efficacy trials. Information regarding maintenance of effect or long-term outcomes beyond this 12-week period is considered insufficient.


Q: Can people with oily skin use Arazlo?

Official regulatory data generally does not specify eligibility based on skin type. Clinical studies are described as having included a broad population of patients presenting with acne vulgaris. The lotion vehicle is generally recognized for its non-greasy cosmetic properties.


Q: Why is Arazlo sometimes prescribed instead of other acne treatments?

Arazlo provides the active ingredient tazarotene in a specific 0.045% lotion formulation. The product is characterized by its specific retinoid class and its lotion vehicle. These are key characteristics that define Arazlo within the available options for acne therapy.

How should Arazlo be stored and disposed of?

How to Store and Dispose of Arazlo?

Storage Requirements

Arazlo (tazarotene) lotion must be stored under controlled conditions to maintain product stability. The required storage environment is room temperature, specifically maintained between 68 F and 77 F (20 C to 25 C). It is mandatory that the lotion not be frozen and that it be kept protected from excessive heat, moisture, and direct light.

Condition Requirement
Temperature 20 C to 25 C (68 F to 77 F)
Prohibited Do not freeze; avoid excessive heat and light
Safety Keep out of the reach of children and pets

Disposal Instructions

Any unused or expired Arazlo must be discarded appropriately. Official regulatory instructions advise asking a healthcare professional how to safely dispose of any unused medicine. If take-back options are unavailable, the medication should be mixed with an undesirable substance, sealed in a container, and placed in the household trash.

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

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