Acitretin

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Acitretin

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 Acitretin

Property Description
Active ingredient Acitretin (INN)
Form Capsules (for systemic treatment)
Pharmacological class Retinoid (Second-Generation Aromatic)
Origin Synthetic derivative (metabolite of Etretinate)
Target Mechanism Modulation of Keratinocyte Differentiation

What Type of Medicine is Acitretin?

Acitretin is a synthetic, orally administered prescription medicine classified as a retinoid, which places it in a drug class chemically related to Vitamin A (Retinol). It is specifically defined as a second-generation and aromatic retinoid, synthesized to achieve a precise therapeutic profile. This compound is highly notable for being the major metabolite of the precursor retinoid Etretinate, which Acitretin largely replaced due to its significantly shorter elimination half-life, a key property identified in pharmacological research.

Composition and Form: Systemic Capsule Treatment

The active ingredient in this medication is Acitretin itself, which exists as the free acid form of the substance and is responsible for its therapeutic action. The drug is prepared for systemic treatment and is delivered via oral administration in the form of hard capsules. The formulation ensures the active compound is absorbed internally to manage widespread or severe chronic skin conditions, distinguishing it from topical retinoid preparations designed for local application. This medication is a single active ingredient product.

General Purpose and Benefit for Skin Health

Acitretin’s general purpose is to modulate the pathological life cycle and development of skin cells, particularly keratinocytes. The medication works by binding to nuclear receptors, which ultimately exerts a potent anti-proliferative effect and normalizes the process of keratinization, the formation of the outer protective skin layer. The general therapeutic benefit of this receptor-mediated action is to reduce the excessive thickening, scaling, and cellular overgrowth that characterize chronic, severe dermatological disorders, a role clinically recognized by major regulatory bodies.

Regulatory References

  1. Acitretin - StatPearls - NCBI Bookshelf

What side effects are possible with Acitretin?

Possible Side Effects and Safety Information

The safety profile of Acitretin is characterized by a high incidence of dose-related, reversible side effects, alongside mandatory, strict safety constraints tied to its prolonged teratogenicity risk. The information below is based on regulatory documents.


Common and Expected Adverse Reactions

Adverse reactions are frequently dose-dependent, with the most common ones affecting the skin and mucous membranes. These effects are often temporary or subside with dose adjustment, but may include:

  • Mucocutaneous: Dry skin, cheilitis (chapped lips), rhinitis, mucosal dryness, and hair loss (alopecia).
  • Metabolic: Elevated serum triglycerides and cholesterol levels, requiring regular monitoring.
  • Musculoskeletal: Joint pain (arthralgia) and muscle pain (myalgia).

Serious Adverse Reactions and Safety Constraints

Acitretin carries significant risks that require strict management and patient compliance:

  • Teratogenicity (Birth Defects): Acitretin is highly teratogenic. Women of childbearing potential are required to use strict contraception during therapy and for three years after stopping the medication.
  • Hepatotoxicity: The drug can cause severe liver injury (hepatitis) and significant elevation of liver enzymes. Regular monitoring of liver function tests is mandatory.
  • Skeletal Changes: Hyperostosis and other bone changes, including premature closure of the growth plates in children, are risks, particularly with long-term use.
  • Alcohol and Blood Donation: Alcohol consumption is prohibited during and for two months after treatment in women of childbearing potential. Blood donation is forbidden during treatment and for three years after the last dose.

Overdose and Emergency Response

The official regulatory documentation on Acitretin overdose focuses on documented clinical manifestations and required emergency actions. Overdosage is primarily associated with acute symptoms that resemble Hypervitaminosis A (excess Vitamin A in the body). The documented manifestations requiring immediate attention include severe and continuing headache, dizziness or lightheadedness, and the feeling of vertigo or a sensation of spinning. Regulatory guidance explicitly states that emergency medical help must be sought immediately if these symptoms of overexposure occur.

The management context of Acitretin overdose includes specific procedural constraints documented in official labeling. It is noted that Acitretin was not removed by hemodialysis in patients with end-stage renal failure, a factor critical for clinical monitoring and management. Furthermore, a significant regulatory warning addresses exposure in female patients of childbearing potential: the co-ingestion of ethanol (alcohol) with Acitretin is associated with the formation of the metabolite Etretinate. Because Etretinate has a significantly longer half-life than Acitretin, its formation results in a prolonged teratogenic risk lasting at least three years, a key consideration in any overexposure scenario. The official profile strictly conveys these clinical signs and management facts.

Therapeutic Uses of Acitretin

What Acitretin Treats: Main Uses and Benefits

Acitretin is a specialized systemic medication that is commonly used in the management of severe, chronic skin diseases, particularly those involving disorders of keratinization and severe psoriasis. It is applied across therapeutic domains where additional symptomatic support is needed in conditions that involve pathological skin changes. It is considered relevant in clinical settings that involve acute or unstable symptom patterns that have previously proven difficult to manage. The medication is indicated for the treatment of severe psoriasis in adults.


Therapeutic Scope and Benefit

The medication is primarily used for the therapeutic domain of severe and extensive psoriasis, addressing forms like generalized pustular psoriasis and erythrodermic psoriasis. It helps manage symptom clusters related to widespread scaling, pronounced redness (erythema), and cellular overgrowth that interfere with daily functioning. Acitretin is also commonly used across conditions presenting with disorders of keratinization, such as Ichthyosis and Darier disease.

It is commonly used when symptoms intensify and supportive relief is needed, and is considered relevant in settings that involve chronic maintenance and stabilization. The medication supports the patient during difficult episodes by easing distress associated with widespread, severe skin inflammation and pathological thickening.


Quick Fact

Quick Fact: Support for Symptoms of Pathological Skin Thickening Acitretin plays a role in managing conditions that present with significant symptomatic burden, specifically is applied in addressing the severe hyperkeratosis and infiltration relevant in conditions characterized by periods of heightened symptoms.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Acitretin — Official Regulatory Information

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults with severe, chronic skin disorders who meet all mandatory safety protocols.
Populations for whom use is not recommended Pediatric patients, due to safety and efficacy not established and potential long-term skeletal risks. Geriatric patients require caution due to potential age-related organ decline.
Populations for whom use is contraindicated Pregnant women; Women of childbearing potential not complying with mandatory contraception and alcohol abstinence requirements; Patients with severe hepatic or severely impaired renal function; Patients with chronic, abnormally elevated blood lipids.
Age-related eligibility rules Primarily restricted to Adult use. Pediatric use is generally not recommended. Geriatric use requires caution.
Condition-specific eligibility rules Contraindicated in patients with a known hypersensitivity to acitretin or other retinoids. Contraindicated with concomitant use of Methotrexate or Tetracycline antibiotics.
Pregnancy and lactation eligibility status Strictly Contraindicated in pregnancy and for three years following the final dose. Contraindicated in nursing/lactating mothers.
Eligibility-related restrictions Blood Donation is prohibited during therapy and for three years after cessation (all patients). Women of childbearing potential must avoid alcohol during therapy and for two months after the last dose.

Eligibility classifications (high-level)

Classification Official Regulatory Wording
Eligibility severity classification Contraindicated (absolute prohibition); Not Recommended (pediatric/lactation); Use with Caution (metabolic/geriatric); Not Established (pediatric safety).
Regulatory basis Boxed Warning / Contraindication Section / Special Populations Section.
Eligibility-context constraints Pregnancy Prevention Programme (PPP) compliance; 3-year post-treatment avoidance of pregnancy and blood donation; 2-month post-treatment alcohol abstinence.

Resulting eligibility structure Official eligibility statements:

  • Acitretin is contraindicated in women who are pregnant or who may become pregnant during therapy or at any time for at least three years following discontinuation.
  • The medicine is contraindicated in patients with severe hepatic impairment or severely impaired renal function.
  • Pediatric use is generally not recommended or stated as safety and efficacy not established due to potential skeletal effects.

Connection to the overall eligibility profile: Regulatory documents define Acitretin's eligibility with stringent exclusions, primarily based on its status as a potent teratogen, which necessitates multi-year post-treatment restrictions on pregnancy and blood donation. Eligibility is further restricted by absolute contraindications relating to pre-existing organ dysfunction and metabolic disorders, ensuring the drug is used only in the allowed adult population under strictly defined conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail specific constraints regarding the co-administration of Acitretin with other substances, primarily due to pharmacokinetic and pharmacodynamic interactions.

Critical Interaction Constraints

Interacting Product/Class Mechanism/Effect Regulatory Requirement
Ethanol (Alcohol) Metabolic conversion of Acitretin to Etretinate, a substance with a significantly longer half-life. Prohibited in females of childbearing potential during and for 2 months after treatment, extending the period of required contraception.
Tetracycline Antibiotics Increased risk of pseudotumor cerebri (benign intracranial hypertension) through an unknown pharmacodynamic effect. Not recommended for concomitant use.
Microdosed Progestin Preparations (Minipills) Interferes with the contraceptive efficacy, leading to potential failure. Not recommended; use two effective non-progestin methods of birth control.
Methotrexate Risk of additive hepatotoxicity (liver damage). Use together is generally not recommended.
Vitamin A Preparations Risk of additive retinoid toxicity (hypervitaminosis A). Prohibited; supplemental Vitamin A must not be taken.

These constraints define the official interaction profile for Acitretin, focusing on preventing the formation of a long-acting teratogenic metabolite and mitigating the risk of serious additive toxicities (hepatotoxicity, intracranial pressure, and contraceptive failure).

Mechanism of Action

Acitretin exerts its pharmacological effect by acting as an agonist for nuclear transcription factors known as Retinoic Acid Receptors ( RARs) and Retinoid X Receptors ( RXRs). Binding to these receptors facilitates the formation of functional RAR-RXR heterodimers, which subsequently bind to specific DNA sequences ( RAREs). This interaction modulates gene transcription, altering the cellular program of target cells.

The primary consequence of this modulation is on keratinocyte kinetics. The mechanism exerts an anti-proliferative effect, slowing the rate of cell division, and promotes the orderly maturation, or differentiation, of skin cells. This dual action leads to the physiological restructuring of the epidermal layers.

Furthermore, Acitretin engages in immunomodulation by suppressing the synthesis of specific proinflammatory cytokines (e.g., IL-6) and influencing immune cell activity, which reduces the level of inflammatory mediators. The overall action is constrained by reliance on slow gene regulation, resulting in delayed effects, and the potential for reverse metabolism (transesterification) to the highly persistent precursor, Etretinate.

Dosage and Administration Information

How to Use Acitretin

Acitretin is provided for systemic treatment as an oral capsule and is administered once daily as a single dose. The capsules are taken with food, specifically with the main meal of the day or a glass of milk, which assists in ensuring the medicine is properly absorbed into the body.

The typical adult dosing regimen begins with an initial dose often in the range of 25 to 50 mg daily for conditions like severe psoriasis. The medicine is then subject to a phase of dose titration where the dose is adjusted based on the individual's response and tolerability, with the daily dosage generally not exceeding 75 mg. For chronic disorders of keratinization, such as Ichthyosis, the maintenance dose is kept as low as possible and typically does not exceed 30 mg daily.

Regarding the duration of use, therapy for psoriasis is usually discontinued once the lesions have improved sufficiently. However, conditions characterized by keratinization disorders may require continuous, long-term therapy beyond three months. If a dose is missed, the standard protocol is to skip the missed dose and take the next dose at the regularly scheduled time; double doses are avoided. The dosage recommendations for older adults are the same as for other adult patients, though the drug's safety and effectiveness have not been formally established for use in pediatric patients.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Acitretin


Evidence for Severe Psoriasis

Research exploring Acitretin for severe psoriasis, including extensive plaque psoriasis and forms like generalized pustular and erythrodermic psoriasis, has been conducted primarily using short-term Randomized Controlled Trials (RCTs). These studies were used in research exploring how common symptoms like scaling and redness are measured. Researchers monitored how measurements of physical discomfort and symptom intensity change, primarily by examining standardized severity scores like the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA).

Studies conducted during periods of increased symptom activity described patterns observed in the Acitretin groups when compared to control groups over initial treatment periods, typically lasting 8 to 16 weeks. Findings describe changes measured during the study period for key symptoms like scaling, redness, and thickness based on physician ratings. Further open-label studies and long-term observational settings evaluated daily-life functioning by tracking patients who continued in the studies over time.

The certainty for long-term outcomes is not fully established. While data show patterns observed over time in some patients followed in observational settings for up to a year or longer, controlled evidence for the patterns of change over time remains limited. Comparative evidence is lacking against the newer, targeted treatments now available for severe psoriasis, as the key initial research was conducted before these options were widely available.


Evidence for Severe Disorders of Keratinization

For conditions characterized by fluctuating or episodic manifestations like severe Ichthyosis and Darier disease, the evidence base relies on a different research approach due to their rarity. Acitretin was evaluated in smaller clinical trials, case series, and descriptive case reports. This research examined temporary physiological imbalance and was used in studies exploring patient-reported experiences related to scaling and skin thickening (hyperkeratosis).

Studies report how symptoms evolved in the observed populations, focusing on outcomes related to physical discomfort, such as changes in the extent of lesions and the overall appearance of the skin based on clinical assessment. The evidence is limited by very small sample sizes for many specific subtypes of these disorders, and the overall evidence quality varies across studies. The findings describe group patterns, not personal outcomes, and research provides context but not individual predictions.


What the Research Does Not Yet Fully Address

Comparative evidence is lacking, particularly head-to-head trials against the newer, targeted treatments now available for severe psoriasis. While studies monitor short-term changes, there is limited information for long-term outcomes established under rigorous, controlled research conditions. The evidence quality varies across studies. This means research does not determine whether an individual will respond similarly, and certainty remains low for many long-term or niche applications.

Key Studies & References

  1. Acitretin - StatPearls (Review of use in Ichthyosis, Darier disease, and pediatric population data)

Frequently Asked Questions (FAQ)

Common questions about Acitretin (FAQ)


Q: How quickly does Acitretin start to show an effect?

Studies and official information indicate that the therapeutic effect of Acitretin is typically delayed because it works by modulating gene regulation. While some effect patterns may begin after two to four weeks, the maximum improvement observed in clinical research often occurs after about 12 weeks of treatment.


Q: Can Acitretin cure my skin condition permanently?

Regulatory documents describe the use of Acitretin for the management of severe, chronic skin disorders. The treatment is intended to improve symptoms and lesions, but official sources do not describe it as a permanent cure. Depending on the condition, the treatment may be discontinued once symptoms improve or it may be necessary to continue it as a long-term management therapy.


Q: What are the most common reasons a doctor would prescribe Acitretin?

Official prescribing information indicates Acitretin is used for the treatment of severe forms of psoriasis (including erythrodermic and pustular types) and other serious, chronic disorders of keratinization. The medicine is often reserved for cases where the condition is described as physically, occupationally, or psychologically disabling.


Q: Is it normal to experience dryness while taking Acitretin?

Yes, regulatory documents list dryness affecting the skin and mucous membranes as very common and expected adverse reactions to Acitretin. These frequently reported effects include dry skin, chapped lips (cheilitis), and dryness inside the nose (rhinitis).


Q: Does Acitretin cause hair loss?

Official prescribing documents list hair loss (alopecia) as a common adverse reaction associated with Acitretin use. This side effect is often described as being dose-dependent and typically reversible upon dose adjustment or discontinuation of the medicine.


Q: How long can a person safely take Acitretin?

Regulatory guidance states that treatment duration for conditions like psoriasis is determined by the individual's response. However, some chronic disorders may require long-term therapy. Regulatory guidance advises that monitoring for signs of potential skeletal changes, such as hyperostosis (excessive bone growth), is necessary for patients on long-term treatment.


Q: Does sun exposure need to be completely avoided while using Acitretin?

Official patient information often warns that Acitretin can increase the skin's sensitivity to the sun, leading to a greater risk of sunburn. Because of this photosensitivity, official guidance describes that patients should limit sun exposure and use protective measures like sunscreen and covering clothing.


Q: Can men use Acitretin without any reproductive concerns?

Regulatory documents require that all patients, male and female, must not donate blood during therapy and for three years after stopping the drug. Available data suggests it is highly unlikely that any fetal malformation could be caused by trace amounts of Acitretin in a father’s ejaculate, and post-marketing surveillance has not associated paternal use with birth defects.


Q: What information does regulatory guidance provide about severe side effects?

Regulatory documents require that patients be informed about the signs of serious adverse events, such as severe, persistent headaches, changes in vision, or yellowing of the skin (jaundice). Clinicians are advised that the drug should be stopped and the cause investigated if serious symptoms or significant abnormalities in lab tests (like liver enzyme or lipid elevations) occur.


Q: Can Acitretin cause changes in mood or mental health?

Official safety warnings advise that changes in mood and behavior have been reported with oral retinoids like Acitretin. These reports include instances of depression, the worsening of existing depression, and anxiety. Patients are advised to monitor for any changes in their mood.


Q: How is the effect of Acitretin measured by doctors?

Doctors assess the effect of Acitretin primarily through patient observation, as well as by monitoring for changes in symptoms of the underlying skin condition. Regular monitoring of liver enzymes and fasting lipid (fat) levels in the blood is also mandated by regulatory guidance to ensure the drug's safety and progression.


Q: Are there different brand names for the medicine Acitretin?

Yes, Acitretin is the generic name for the medicine. It has historically been sold under various brand names, with the most common ones including Soriatane and Neotigason.


Q: Does Acitretin affect vision or cause eye dryness?

Regulatory documents list ophthalmic (eye-related) adverse reactions as possible side effects. These include dry eyes (xerophthalmia), irritation of the eyes, and a potential decrease in night vision.


Q: Is Acitretin considered a biological therapy?

No, Acitretin is classified as a synthetic, second-generation aromatic retinoid. This means it is a man-made compound chemically related to Vitamin A, which puts it into a different category than biological therapies.


Q: What happens if I forget to take Acitretin with food?

Official guidance states that Acitretin must be taken with food (such as a main meal or milk) because its proper absorption into the body is significantly reduced if it is taken on an empty stomach. Taking it without food could make the medicine less effective in treating the skin condition.


Q: Are there restrictions on dental procedures while taking Acitretin?

While there are no general restrictions on the procedures themselves, regulatory guidance advises against the concomitant use of Acitretin with certain medicines that may be administered during dental care, such as tetracycline antibiotics, due to the risk of additive side effects like increased pressure in the brain.


Q: Does Acitretin affect bone density?

Regulatory documents report that Acitretin, particularly when used long-term, can cause skeletal abnormalities. These reported changes include hyperostosis (excessive bone growth) and changes to the vertebrae, which necessitates monitoring during extended use.


Q: Is Acitretin effective for skin conditions in children?

Regulatory information indicates that the safety and effectiveness of Acitretin have not been established in pediatric patients. Due to the potential for long-term skeletal risks, such as the premature closure of growth plates, its use is generally not recommended for children.


Q: Are there studies on Acitretin use in elderly patients?

Regulatory and clinical guidance recommends that Acitretin should be used with caution in elderly patients. This caution is primarily due to the potential for slower elimination of the drug from the body and the general decline in organ function associated with age.


Q: Can Acitretin cause birth defects if taken by the father?

Available data suggests it is highly unlikely that any fetal malformation could be induced by an ejaculate containing traces of Acitretin. Post-marketing surveillance worldwide has not associated paternal use with birth defects. However, official requirements state that all patients must not donate blood for three years after stopping treatment.


Q: What type of skin conditions does Acitretin specifically treat?

Acitretin is officially indicated for the treatment of severe, persistent forms of psoriasis, including erythrodermic and pustular types. It is also used for other severe, chronic disorders of keratinization.


Q: What is the purpose of the initial lower dose of Acitretin?

The strategy of starting at a lower initial dose, followed by gradual increases, is employed because many of the drug's adverse effects are dose-dependent. The primary aim is to allow the patient's body to better tolerate the medicine and to help determine the minimum effective dose while minimizing the occurrence of side effects.

How should Acitretin be stored and disposed of?

How to Store and Dispose of Acitretin?

Acitretin capsules require specific storage conditions to maintain stability and effectiveness, as mandated by regulatory labeling.


Storage Requirements

  • Temperature: Store at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). Brief excursions up to 30 C are generally permitted.
  • Protection: The medicine must be protected from light and moisture. Store the capsules in the original container and keep it tightly closed in a dry place.
  • Child Safety: Acitretin must be kept out of the reach of children.

Disposal Instructions

Unused or expired acitretin must be disposed of in accordance with local regulations. Due to its classification, it must not be discarded into household trash or flushed down a toilet; disposal must be managed through approved waste disposal or medicine take-back programs to avoid release to the environment.

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

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