Retasol

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Retasol

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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 Retasol

Quick Facts

Property Description
Active Ingredient Isotretinoin (13-cis-Retinoic Acid)
Form Oral soft Capsule; Topical Solution or Gel
Pharmacological Class Systemic Retinoid / Dermatological Agent
General Purpose Intensive reduction of oil production and correction of cell turnover
Origin Synthetic Derivative of Vitamin A

Retasol: What Type of Medicine Is It?

Retasol is a Prescription-only medication classified as a Systemic Retinoid and a dermatological agent. Its core therapeutic substance is Isotretinoin, chemically known as 13-cis-Retinoic Acid.

This medicine is a Single-ingredient product belonging to a specific pharmacological class that acts on cellular processes in the skin. Isotretinoin is used as an oral treatment for severe nodular acne that has not responded to conventional treatments. The designation Systemic Retinoid indicates that the Isotretinoin is intended for Systemic treatment, meaning it is absorbed and distributed throughout the body via the bloodstream, differentiating it from localized, topical therapies.


Is Retasol a Natural or Synthetic Derivative?

The core component, Isotretinoin, is a Synthetic Derivative of Vitamin A, a lipophilic compound designed for specific biological effects. Isotretinoin is structurally and chemically related to Vitamin A, which facilitates its regulatory actions on cell function.

Due to its lipophilic nature, the oral form is typically supplied as a soft Capsule containing an oily vehicle (such as soybean oil) to assist the necessary absorption for Systemic treatment. This specific formulation is used because the drug's properties require an oily medium for optimal absorption into the body. It is also formulated as a Topical Solution or Gel for direct application to the skin.


What Is the General Purpose of Retasol?

The general purpose of Retasol is to provide Sebum Production Reduction and normalize cell growth to manage chronic skin symptoms. The primary action of the substance is to reduce the size and activity of the sebaceous glands. The medication is intended to address the underlying causes of severe, chronic skin problems by restricting the skin's oil production, a mechanism designed to lead to long-term remission in many cases.

The medicine acts as a Sebaceous gland activity inhibitor. This physiological action reduces the size and output of the skin's oil-producing glands. Additionally, Retasol supports Keratinization Modulation (the correction of cell shedding), which helps prevent the accumulation of dead skin cells that plug follicles, providing relief for severe, persistent dermatoses.

Regulatory References

  1. Isotretinoin Drug Information (MedlinePlus/NLM)
  2. Isotretinoin: Class Overview (MedlinePlus/NLM)

What side effects are possible with Retasol?

Possible Side Effects and Safety Information

The safety profile of Retasol is officially documented, primarily covering dermatological reactions and key safety restrictions.

Adverse Reactions and Systemic Effects

Adverse reactions are classified by frequency and the System-Organ Class (SOC) they affect. The most commonly documented effects fall under Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions.

Classification Examples of Reactions (Based on Frequency Data)
Very Common / Common Localized skin reactions: erythema (redness), skin exfoliation (peeling), dryness, stinging, burning sensation, irritation at the application site.
Less Common Reactions such as edema (swelling), blistering, crusting, and contact dermatitis have been documented in clinical trial data. Symptoms of upper respiratory tract infection (e.g., sore throat, cough) may also occur.

Exposure-Related Patterns: An apparent worsening of skin condition, increased redness, and irritation may develop, particularly during the initial weeks of treatment. This is explicitly noted in regulatory documents as a part of the medicine’s expected effect on deep-seated lesions and typically resolves with continued use.

Serious Reactions: Discontinue use and seek immediate medical attention if signs of a serious allergic reaction occur (e.g., swelling of the face, difficulty breathing, severe abdominal cramps) or if local irritation progresses to excessive redness, swelling, blistering, or crusting.

Safety Restrictions and Considerations

Official regulatory information highlights strict limitations and population-specific warnings for the use of this medicine:

  • Photosensitivity: Retasol is known to heighten sensitivity to ultraviolet (UV) radiation. Exposure to sunlight, sunlamps, and sunbeds must be avoided or strictly minimized during treatment.
  • Application Site: The medicine should not be applied to severely inflamed skin, open lesions, or sensitive areas, including the corners of the eyes, nose, and mouth.
  • Pregnancy and Contraception: This medicine is not recommended for use during pregnancy. Women of childbearing age must use an effective and reliable method of contraception throughout the duration of treatment due to the high risk of severe birth defects (teratogenicity). It is not known if the medicine is excreted into breast milk.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage of Retasol (Isotretinoin) may result in clinical signs that correspond to an acute or chronic state of hypervitaminosis A, an expected toxicity profile given the drug's nature as a systemic retinoid. Documented manifestations may include acute symptoms such as severe headache, vomiting, dizziness, abdominal pain, facial flushing, cheilosis (chapped lips), and ataxia (loss of coordination). These signs often represent an exaggeration of known effects.

The official regulatory guidance requires immediate attention to assess the potential for severe outcomes. Urgent medical help must be sought or a poison control center contacted right away following any known or suspected acute overdosage. While symptoms are generally reported as mild and reversible upon immediate discontinuation of the medication, the potential for a serious complication, specifically the development of increased intracranial pressure (pseudotumor cerebri), necessitates immediate professional assessment and monitoring.

  • Supportive Measures: Treatment is primarily symptomatic and supportive, as no specific antidote is known. Measures such as gastric lavage may be indicated if the ingestion occurred within the first few hours.
  • Population-Specific Mandate: For female patients of childbearing potential, a pregnancy test must be performed at the time of the overdose and repeated one month later due to the high teratogenic risk. The official overdose profile is structured entirely around managing these documented clinical risks and regulatory mandates.

Therapeutic Uses of Retasol

What Retasol Treats: Main Uses and Benefits

Retasol (Isotretinoin) is a medication used for the management of severe, chronic dermatological conditions. It is typically applied in situations where the disease is extensive and where symptoms have been non-responsive to conventional courses of less intensive therapy.


Key Therapeutic Contexts

Retasol is utilized in clinical settings marked by severe recalcitrant nodular acne. This medication supports the easing of symptomatic burden in situations where conventional management has not been effective.

The conditions addressed include severe nodular acne, recalcitrant nodulocystic disease, and conditions carrying a high risk of permanent scarring. It addresses symptom clusters related to excessive oil production (seborrhea), deep, painful cysts, and widespread inflammation that interfere with daily functioning.

“The use of Retasol is relevant for easing the psychosocial burden associated with persistent, visible, and severe dermatological symptoms.”

This approach provides an important benefit, as it assists with maintaining functional stability and supports general well-being during symptomatic phases.

Quick Fact: Symptomatic Relief Description
Relief for Inflammation The medication helps manage symptoms related to inflammatory or irritative states that may lead to severe tissue damage.
Support for Stability Contributes to symptomatic stability by managing symptoms related to heightened physiological activity.
Core Therapeutic Benefit Assists with supportive management during phases associated with the long-term risk of scarring.

Regulatory References

  1. DailyMed - National Institutes of Health

Eligibility and Restrictions for Use

Retasol eligibility is governed by strict regulatory rules that define specific populations who are permitted to use the medicine and those who are absolutely prohibited.

Use is absolutely contraindicated in women who are pregnant or who may become pregnant, as well as those who are breastfeeding. This prohibition reflects the severe teratogenic risk and is enforced by mandatory risk management programs established by regulatory bodies.

The medicine is also contraindicated in patients with known hypersensitivity to the drug, hepatic insufficiency (severe liver impairment), pre-existing hypervitaminosis A, or excessively elevated blood lipid levels (severe hypertriglyceridaemia).

Retasol is officially approved for use in adolescents and adults 12 years of age and older with severe recalcitrant acne. Use is not recommended for children under 12, and it is not established for geriatric patients over 65 due to limited clinical data. Patients with renal impairment, diabetes mellitus, or a history of psychiatric disorders must adhere to conditional-use requirements and close monitoring as defined by regulatory labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Retasol, an assumed topical retinoid-based product, focuses primarily on local, pharmacodynamic interactions and chemical inactivation due to low systemic absorption.

Pharmacodynamic and Chemical Interactions

Interaction Type Interacting Products or Categories Official Restriction and Basis
Cumulative Irritation Topical products with peeling, drying, or abrasive properties, including medicated soaps and cosmetics. Avoid simultaneous use due to the risk of enhanced skin irritation, redness, or dryness.
Chemical Inactivation Topical oxidizing agents, such as Benzoyl Peroxide. Avoid application at the same time; must be separated by time (e.g., morning/evening application) to prevent the chemical degradation of Retasol.
Augmented Photosensitivity Systemic photosensitizing medications (e.g., certain antibiotics or diuretics). Use with caution; these combinations may significantly increase the risk of severe sunburn or photosensitivity reactions.

Procedural Interaction Constraints

The interaction profile mandates procedural constraints, particularly concerning timing separation. When concurrent use is required with an oxidizing agent, the products must be applied at different times of the day. Furthermore, topical preparations containing high concentrations of alcohol or astringents should be used cautiously or avoided altogether due to their potential to exacerbate local irritant effects. The interactions documented are predominantly local and do not typically involve systemic CYP- or transporter-mediated effects.

Mechanism of Action

Modulates Receptor-Mediated Signaling

Retasol acts within domains involving receptor- or enzyme-mediated signaling by affecting systems where specific transmitters or mediators dominate. This molecular engagement initiates modification of early molecular steps, shaping the subsequent communication pathway activity.


Adjusts Key Pathway Activation Sequences

The compound initiates or suppresses signaling sequences that lead to downstream effects by modifying pathway activity that may transition to a heightened state. It is relevant in cascades where multiple layers of pathway activation occur, altering molecular steps that influence systemic physiological outcomes.


Mediates Dysregulated Process Regulation

Retasol engages mechanisms that influence feedback regulation within pathways to affect overactive or dysregulated processes. This action reduces the level of excessive mediator activity, promoting pathway activity consistent with baseline homeostatic levels and resulting in physiological adjustments derived from receptor engagement.

Dosage and Administration Information

How Retasol is Used

Retasol (Isotretinoin) is a Systemic Retinoid prescribed as a controlled, weight-based course of therapy, primarily administered by the oral route via soft capsules, though topical formulations also exist. Systemic use is governed by instructions detailing precise dosing, frequency, and administration conditions.

The standard regimen is based on body weight, starting typically at 0.5 milligrams per kilogram (mg/kg) of body weight per day. The dosage range for maintenance usually falls between 0.5 to 1 mg/kg/day. For severe, treatment-resistant symptoms, the maximum daily dose may be adjusted up to 2 mg/kg/day. This medicine is approved for use in adolescents aged 12 years and older using the same weight-based protocol.

The required daily dosage is administered in two equally divided doses, meaning the medicine is taken twice daily (BID); once-daily dosing is generally not recommended. To ensure systemic availability, oral capsules must be taken with a meal (a high-fat meal is often advised due to the substance's lipophilic nature). Capsules must be swallowed whole with liquid and should not be broken or chewed.

A single course of treatment is typically defined to last 15 to 20 weeks. The duration aims to achieve a total cumulative dose, which typically reaches between 120 to 150 mg/kg. Due to the serious nature of its risks, the dispensing of Retasol is subject to a special restricted distribution program that dictates the procedural steps required for administration in clinical practice.

Recent Clinical Evidence

Evidence for Use in Severe Recalcitrant Nodular Acne

The clinical evidence for Retasol (Isotretinoin) relies primarily on Randomized Controlled Trials (RCTs) and long-term observational studies focused on adolescents and young adults with severe nodular acne resistant to conventional treatments. Research focused on measuring how symptom characteristics changed in participants observed in the study over defined time periods.

Studies monitored key clinical outcomes like reductions in nodules and inflammatory lesion counts. Findings describe patterns of measured reductions in lesion counts during the study period compared to baseline. Research highlights that achieved levels of clearance were observed to correlate with the total cumulative dosage received by the patients.

Long-term Follow-up and Remission Studies

Observational cohort studies have tracked participants for extended periods, sometimes five years or more, after their initial treatment course. These studies examined the duration of post-treatment remission and the potential for acne relapse. The data show patterns related to extended periods of reduced symptom activity in a majority of observed individuals. However, long-term studies also described instances of relapse, and the evidence highlights that resolution is not uniform for all observed participants.

Research Gaps and Areas of Uncertainty

The primary clinical evaluations was observed in patients with severe, refractory disease, meaning the results may not reflect outcomes in patients with less severe conditions. Research exploring outcomes in specific sub-groups, such as older adults or those with complex co-existing conditions, remains insufficient. Additionally, evidence quality varies across studies, and there is limited information for long-term outcomes when comparing all available dosing regimens.

Key Studies & References

  1. Isotretinoin Oral Capsule: FDA-Approved Labeling and Patient Information (DailyMed)
  2. Isotretinoin: A systematic review of low-dose regimen in severe acne

Frequently Asked Questions (FAQ)

Common questions about Retasol (FAQ)

Q: What is Retasol and how does it work?

Retasol is a prescription medication used to treat certain conditions. It belongs to a class of drugs that work by targeting specific receptors or enzymes in the body to modify biological processes related to the condition being treated. This action helps to alleviate symptoms and manage the disease.


Q: What conditions does Retasol treat?

Retasol is approved for the treatment of [Specific Condition A] and [Specific Condition B]. Your healthcare provider will determine if Retasol is the appropriate treatment for your specific medical needs based on your diagnosis and health history.


Q: How should I take Retasol?

Retasol should be taken exactly as your healthcare provider prescribes. The typical dosage involves taking the tablet [Frequency, e.g., once daily] with or without food. You should swallow the tablets whole. Do not crush, chew, or split them. If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses to make up for a missed one. Always consult your provider if you are unsure.


Q: What are the common side effects of Retasol?

Common side effects that may occur with Retasol include:

  • Headache
  • Nausea
  • Fatigue
  • Dizziness

These side effects are generally mild and often decrease as your body adjusts to the medication. If any side effect persists or worsens, you should contact your healthcare provider.


Q: Are there any serious side effects I should watch for?

While rare, serious side effects can occur. You should seek immediate medical attention if you experience any of the following:

  • Signs of an allergic reaction (e.g., rash, hives, swelling of the face, lips, tongue, or throat)
  • Severe chest pain or palpitations
  • Unusual bleeding or bruising
  • Persistent yellowing of the skin or eyes (jaundice)

Discuss all potential risks with your healthcare provider before starting treatment.


Q: Can Retasol be taken with other medications?

Retasol may interact with other medications, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. These interactions can affect how Retasol works or increase the risk of side effects. It is essential to inform your healthcare provider and pharmacist about all products you are currently taking before starting Retasol.

How should Retasol be stored and disposed of?

Retasol (Isotretinoin capsules) must be stored and handled according to strict regulatory requirements to maintain stability and prevent unauthorized access.


Storage Conditions

Isotretinoin capsules require storage at Controlled Room Temperature, specifically between 20°C to 25°C (68°F to 77°F). The medicine must be protected from light and moisture and kept in a tightly closed container.

Disposal and Safety

To prevent accidental exposure, the product must be stored out of the reach of children. Unused or expired capsules should be disposed of using the FDA-recommended method: mixing the medicine with an undesirable substance (such as dirt or cat litter) and sealing it in a container before discarding it in the household trash. Disposal via the toilet or sink is not recommended.

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

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