acitretin (Rx)

Brand and Other Names:Soriatane
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg
  • 25mg

Psoriasis

25-50 mg PO qDay

Other Indications & Uses

Off-label: Darier's disease, palmoplantar pustulosis, lichen planus, Sjogren-Larsson syndrome

Safety and efficacy not established

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Interactions

Interaction Checker

and acitretin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (8)

            • demeclocycline

              demeclocycline, acitretin. Other (see comment). Contraindicated. Comment: Both acitretin and tetracyclines can cause increased intracranial pressure.

            • doxycycline

              doxycycline, acitretin. Other (see comment). Contraindicated. Comment: Both acitretin and tetracyclines can cause increased intracranial pressure.

            • ethanol

              acitretin, ethanol. Mechanism: altering metabolism. Contraindicated. Ethanol converts acitretin to etretinate, a teratogenic substance that can remain in the body for years. Women on acitretin should totally abstain from ethanol during and 2 months after stopping acitretin.

            • methotrexate

              acitretin, methotrexate. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Risk of additive hepatotoxicity.

            • minocycline

              minocycline, acitretin. Other (see comment). Contraindicated. Comment: Both acitretin and tetracyclines can cause increased intracranial pressure.

            • omadacycline

              acitretin increases toxicity of omadacycline by Mechanism: unknown. Contraindicated. Concomitant use of oral retinoids with tetracyclines may increase the risk of pseudotumor cerebri/intracranial hypertension. .

            • sarecycline

              acitretin increases toxicity of sarecycline by Mechanism: unknown. Contraindicated. Concomitant use of oral retinoids with tetracyclines may increase the risk of pseudotumor cerebri/intracranial hypertension. .

            • tetracycline

              tetracycline, acitretin. Other (see comment). Contraindicated. Comment: Both acitretin and tetracyclines can cause increased intracranial pressure.

            Serious - Use Alternative (6)

            • aminolevulinic acid oral

              aminolevulinic acid oral, acitretin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.

            • aminolevulinic acid topical

              acitretin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • medroxyprogesterone

              acitretin decreases effects of medroxyprogesterone by unknown mechanism. Avoid or Use Alternate Drug. Contraceptive failure may result.

            • methyl aminolevulinate

              acitretin, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • norethindrone

              acitretin decreases effects of norethindrone by unknown mechanism. Contraindicated. Contraceptive failure may result.

            • norethindrone acetate

              acitretin decreases effects of norethindrone acetate by unknown mechanism. Contraindicated. Contraceptive failure may result.

            Monitor Closely (2)

            • nitazoxanide

              nitazoxanide, acitretin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Use Caution/Monitor.

            • ospemifene

              acitretin, ospemifene. Either increases levels of the other by plasma protein binding competition. Modify Therapy/Monitor Closely.

            Minor (1)

            • vitamin A

              acitretin increases toxicity of vitamin A by pharmacodynamic synergism. Minor/Significance Unknown. (Vitamin A) Additive retinoid effects.

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            Adverse Effects

            >10%

            Cheilitis (>75%)

            Alopecia (50-75%)

            Hypertriglyceridemia (50-75%)

            Skin peeling (50-75%)

            Dry skin (25-50%)

            Dysglycemia (25-50%)

            Increased LFT (25-50%)

            Nail disorder (25-50%)

            Pruritus (25-50%)

            Rhinitis (25-50%)

            arthralgia (10-25%)

            changes in phosphorus, potassium, sodium, & magnesium levels (10-25%)

            Dry mouth (10-25%)

            Epistaxis (10-25%)

            Erythematous rash (10-25%)

            Hepatotoxicity (10-25%)

            Hyperesthesia (10-25%)

            Paresthesia (10-25%)

            Paronychia (10-25%)

            Rigors (10-25%)

            Skin atrophy (10-25%)

            Spinal hyperostosis (10-25%)

            Sticky skin (10-25%)

            Xerophthalmia (10-25%)

            1-10%

            Edema

            Flushing

            Depression

            Fatigue

            Headache

            Insomnia

            Somnolence

            Abdominal pain

            Anorexia

            Diarrhea

            Gingivitis

            Increased appetite

            Nausea

            Stomatitis

            Vomiting

            Hot flashes

            Vision changes

            Corneal epithelial abnormality

            Sinusitis

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            Warnings

            Black Box Warnings

            Elevated liver enzymes and hepatitis-related deaths reported

            Use only for severe psoriasis in women who are unresponsive or have contraindications to other therapy

            Should be prescribed by those who understand risk of teratogenic effects and those who are competent in the diagnosis and treatment of severe psoriasis and use of systemic retinoids

            Teratogenic agent; do not use in females who are pregnant, who intend to become pregnant during therapy or within 3 years after discontinuation of therapy, or who may not use reliable contraception during this time period

            Alcohol is contraindicated during treatment with acitretin and for 2 months after stopping therapy as ethanol promotes the formation of etretinate, which has prolonged half-life and teratogenic risk

            Females with childbearing potential must participate in Do Your P.A.R.T. program and have signed Patient Agreement/Informed Consent for Female Patients

            Do not use St. John’s wort due to the effect of decreased birth control effectiveness and potential breakthrough bleeding

            If pregnancy occurs during therapy or 3 yr after discontinuation, prescribers should discuss possible risks for the pregnancy

            Patients should not donate blood during therapy and 3 yr after discontinuation because women with childbearing potential should not receive blood from treated patients

            Males have shown residual amounts of acitretin in seminal fluid, which appears to pose little risk to the fetus, but data are limited

            Requirements for use in women of childbearing potential

            • Use is contraindicated in females with childbearing potential unless patient meets ALL of the following conditions:
            • 1) 2 negative urine or serum pregnancy test results (baseline and 1st 5 days of menses immediately before initiating therapy)
            • 2) Repeated urine or serum pregnancy test monthly during therapy and q3mth during the 3 yr following discontinuation of therapy
            • 3) Committed to use 2 (at least one should be primary) effective forms of contraception simultaneously unless the patient is abstinent, postmenopausal, or has undergone a hysterectomy
            • 4) Use 2 effective forms of contraception simultaneously for at least 1 month prior to therapy, during therapy, and for 3 yr after discontinuing therapy
            • 5) Microdosed “minipill” progestin preparations are not recommended because acitretin interferes with contraception effect and it is unknown whether other progestin contraceptives are adequate contraceptive methods during acitretin therapy

            Contraindications

            Hypersensitivity to retinoids (eg, angioedema, urticaria), parabens

            Coadministration with methotrexate (increased risk for hepatitis)

            Coadministration with tetracyclines (increases ICP, pseudotumor cerebri)

            Alcohol (see Black Box Warnings)

            Severely impairment of liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see Black Box Warnings)

            Pregnancy: teratogenic (see Black Box Warnings)

            Cautions

            Check LFTs 1 day before starting, pregnancy test 2 wk prior to starting therapy

            Hyperostosis reported with long-term treatment

            New or progression of preexisting vertebral/skeletal abnormalities (eg, degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of a cervical disc space)

            Elevated triglycerides and cholesterol reported; monitor for resulting cardiovascular conditions and pancreatitis

            Ophthalmic conditions, including dry eyes, irritation, and brow/lash loss reported

            Pseudotumor cerebri reported

            May cause capillary leak syndrome

            Exfoliative dermatitis and erythroderma reported

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            Pregnancy & Lactation

            Pregnancy Category: X

            Major human fetal abnormalities have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of bones (hip, ankle, forearm, skull, cerebral vertebrae), low-set ears, high palate, decreased cranial volume, and cardiovascular malformations

            Lactation: enters breast milk/not recommended

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Retinoic acid analog

            Pharmacokinetics

            Half-Life: 49 hr

            Peak Plasma Time: 2-5 hr

            Protein Bound: >99.9% (primarily albumin)

            Excretion: 34-54% feces; 16-53% urine

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            acitretin oral
            -
            25 mg capsule
            acitretin oral
            -
            25 mg capsule
            acitretin oral
            -
            10 mg capsule
            acitretin oral
            -
            17.5 mg capsule
            acitretin oral
            -
            25 mg capsule
            acitretin oral
            -
            10 mg capsule
            acitretin oral
            -
            10 mg capsule
            acitretin oral
            -
            25 mg capsule
            acitretin oral
            -
            10 mg capsule
            acitretin oral
            -
            25 mg capsule
            Soriatane oral
            -
            25 mg capsule
            Soriatane oral
            -
            10 mg capsule
            Soriatane oral
            -
            17.5 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            acitretin oral

            ACITRETIN - ORAL

            (A-si-TRE-tin)

            COMMON BRAND NAME(S): Soriatane

            WARNING: Do not use this medication if you are pregnant or planning to become pregnant within 3 years of stopping this drug because it has caused serious birth defects.Use 2 effective birth control methods starting 1 month before taking this medication and at least 3 years after treatment has stopped. Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug.Females who are able to have children must not use this medication unless the following requirements are met: test negative on 2 pregnancy tests (they should be taken 1 week before starting this drug or at least 11 days after the last act of unprotected sexual intercourse); start therapy within 7 days of taking the second pregnancy test; present severe psoriasis and other treatments cannot be used; receive oral and written information on using 2 methods of birth control while taking this drug and for 3 years after stopping it; aware of the dangers of birth control failure and use during pregnancy; understand and correctly follow all birth control requirements and instructions including monthly pregnancy tests during treatment and every 3 months for 3 years after treatment has stopped.Do not drink alcohol while using acitretin and for 2 months after stopping it because alcohol causes this drug to stay in the body longer.It is not known if traces of this drug found in semen of male patients pose a risk to the unborn baby during use or after treatment has stopped.Acitretin may rarely cause serious (possibly fatal) liver disease (hepatitis) and increased fluid pressure on the brain (pseudotumor cerebri). If you notice any of the following unlikely but serious side effects, get medical help right away: yellowing eyes/skin, dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, unusual tiredness, persistent/severe headache, or vision changes (such as blurred/double vision, decreased vision).Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Notify your doctor right away if you develop persistent, lower abdominal pain.Rarely, acitretin may cause serious mental/mood changes, even after stopping the medication. Get medical help right away if you have symptoms such as depression, irritability, aggressive or violent behavior, or thoughts of suicide.

            USES: This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using acitretin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Read and complete the Patient Agreement and Informed Consent document before taking this drug.Take this medication by mouth exactly as prescribed, usually once a day with your main meal.The dosage is based on your medical condition and response to therapy. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of side effects may increase.It may take 2 to 3 months before the full benefit of this medication is seen.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

            SIDE EFFECTS: See also Warning section.You may experience more redness, itching, skin scaling, peeling and dry skin the first several weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, dry mouth, peeling of the skin of fingertips, palms or soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: decreased night vision, fever, chills, dizziness, aches and pain in the bones or joints, muscle pain/tenderness/weakness, difficulty moving, swelling, sudden weight gain, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart disease, diabetes, personal or family history of mental/mood problems (such as depression), receive phototherapy.Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Acitretin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do any activity that requires clear vision (especially at night) until you are sure you can perform such activities safely.Avoid drinking alcohol while taking this medication and for 2 months after stopping it.This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor right away. This drug should not be used if you are planning to become pregnant during treatment or within 3 years after use has stopped.Use 2 effective forms of birth control starting 1 month before and during treatment and at least 3 years after use has stopped. If you are unsure which types of birth control are effective, consult your doctor, pharmacist, or Medication Guide.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor.It is not known if this drug is excreted into breast milk. Breast-feeding is not recommended while using this medication and for at least three years after the medication has been stopped.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: methotrexate, St. John's wort, tetracycline antibiotics, vitamin A.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe headache, nausea, vomiting, drowsiness, irritability, loss of balance, and itching.

            NOTES: See also Warning section.Do not share this medication with others.Laboratory tests (such as liver function tests, X-rays, cholesterol tests, and monthly pregnancy tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, skip the missed dose. Take your next dose at the regular. Do not double the dose to catch up.

            STORAGE: Store this medication at room temperature away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised July 2018. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.