Dosing & Uses
Dosage Forms & Strengths
capsule
- 10mg (generic)
- 25mg (generic)
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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. (Pregnancy Prevention Actively Required During and After Treatment) 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
Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP), or LDH reported; if hepatotoxicity suspected during treatment, discontinue therapy and investigate etiology further
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 cervical disc space)
Exfoliative dermatitis and erythroderma reported
Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm reported in patients taking retinoids; since other factors may contribute to these events, it is not known if they are related to therapy; counsel patients to stop taking this drug and to notify their prescriber immediately if they experience psychiatric symptoms
Minimize exposing treated areas to sun or other UV light; significantly lower doses of phototherapy are required when this drug is used; effects on the stratum corneum induced by this drug can increase the risk of erythema (burning)
Ophthalmic effects
- Ophthalmic conditions including dry eyes, irritation of eyes, and brow and lash loss; Bell’s palsy, blepharitis and/or crusting of lids, blurred vision, conjunctivitis, corneal epithelial abnormality, cortical cataract, decreased night vision, diplopia, itchy eyes or eyelids, nuclear cataract, pannus, papilledema, photophobia, posterior subcapsular cataract, recurrent sties, and subepithelial corneal lesions, reported; patients treated experiencing visual difficulties should discontinue the drug and undergo ophthalmologic evaluation
Pseudomotor cerebri
- Retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension); some events involved concomitant use of isotretinoin and tetracyclines; however, event seen in a single patient was not associated with tetracycline use
- Early signs and symptoms include papilledema, headache, nausea and vomiting, and visual disturbances; patients with these signs and symptoms should be examined for papilledema and, if present, therapy should be discontinued immediately and be referred for neurological evaluation and care
- Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated
Capillary leak syndrome
- Capillary leak syndrome, a potential manifestation of retinoic acid syndrome, has been reported in patients receiving this drug; features of this syndrome may include localized or generalized edema with secondary weight gain, fever, and hypotension
- Rhabdomyolysis and myalgias have been reported in association with capillary leak syndrome, and laboratory tests may reveal neutrophilia, hypoalbuminemia, and an elevated hematocrit; discontinue therapy if capillary leak syndrome develops during therapy
Skeletal abnormalities
- In adults receiving long-term treatment, appropriate examinations should be periodically performed in view of possible ossification abnormalities; as frequency and severity of iatrogenic bony abnormality in adults is low, periodic radiography is only warranted in presence of symptoms or long-term use
- If such disorders arise, continuation of therapy should be discussed with patient on basis of careful risk/benefit analysis; in clinical trials abnormalities of spine that showed new changes or progression of preexisting findings were reported
- Changes included degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of cervical disc space; De novo changes (formation of small spurs) were also reported
Lipids and possible cardiovascular effects
- Blood lipid determinations should be performed before drug is administered and again at intervals of 1 to 2 weeks until lipid response to drug is established, usually within 4 to 8 weeks; elevation in triglycerides and cholesterol reported in clinical trials, respectively; decreased high-density lipoproteins (HDL) also reported in 40% of subjects; these effects of were generally reversible upon cessation of therapy
- Increased tendency to develop hypertriglyceridemia associated with disturbances of lipid metabolism, diabetes mellitus, obesity, increased alcohol intake, or familial history of these conditions; because of risk of hypertriglyceridemia, serum lipids must be more closely monitored in high-risk patients and during long-term treatment
- Hypertriglyceridemia and lowered HDL may increase a patient’s cardiovascular risk status; although no causal relationship established, there have been postmarketing reports of acute myocardial infarction or thromboembolic events in patients on therapy
- .In addition, elevation of serum triglycerides to greater than 800 mg per dL has been associated with fatal fulminant pancreatitis; dietary modifications, reduction in dose, or drug therapy should be employed to control significant elevations of triglycerides; if despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of therapy should be considered
- Triglyceride increases sufficient to be associated with pancreatitis not common; however, fatal fulminant pancreatitis; there have been rare reports of pancreatitis during therapy in the absence of hypertriglyceridemia
Pregnancy & Lactation
Pregnancy
May cause severe birth defects; female patients must not be pregnant when therapy is initiated; they must not become pregnant while taking this drug and for at least 3 years after stopping therapy, so that the drug can be eliminated to below a blood concentration that would be associated with an increased incidence of birth defects; because this threshold has not been established for this drug in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely
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
Studies on lactating rats have shown that retinoids are excreted in the milk; there is one prospective case report where acitretin is reported to be excreted in human milk; nursing mothers should not receive the drug prior to or during nursing because of potential for serious adverse reactions in nursing infants
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| acitretin oral - | 25 mg capsule |  | |
| acitretin oral - | 10 mg capsule |  | |
| acitretin oral - | 25 mg capsule |  | |
| acitretin oral - | 10 mg capsule |  | |
| acitretin oral - | 17.5 mg capsule |  | |
| acitretin oral - | 17.5 mg capsule |  | |
| acitretin oral - | 10 mg capsule |  | |
| acitretin oral - | 25 mg capsule |  | |
| acitretin oral - | 25 mg capsule |  | |
| acitretin oral - | 10 mg capsule |  | |
| acitretin oral - | 25 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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. Consult your doctor for more details.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: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, unusual tiredness, or vision changes (such as blurred/double vision, decreased vision).Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Tell your doctor right away if you develop lower abdominal pain that doesn't go away.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. Also, read and complete the Patient Agreement and Informed Consent document before taking this drug. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, 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 during the first few weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, dry mouth, skin peeling on the fingertips/palms/soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.Remember that this medication has been prescribed because your doctor 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, bone/joint pain, 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: See also Warning section.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/family history of mental/mood problems (such as depression).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. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.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. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell 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.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.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for at least three years after the medication has been stopped. Consult your doctor before breast-feeding.
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: Do not share this medication with others.Lab and/or medical tests (such as liver function, X-rays, cholesterol tests, pregnancy tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. 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 time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from 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 November 2022. Copyright(c) 2023 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.
Formulary
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