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What is Soriatane (acitretin)?
Soriatane (acitretin) is a retinoid used to treat severe psoriasis in adults. Soriatane should be prescribed only by doctors who have experience in the systemic use of retinoids because it has serious side effects.
Common side effects of Soriatane include:
- inflammation of the lips,
- hair loss,
- increased triglyceride levels,
- skin peeling,
- dry skin,
- cold symptoms,
- joint pain, and
- dry mouth.
Other side effects of Soriatane include:
- increased levels of liver enzymes;
- changes in phosphorus, potassium, sodium, and magnesium levels;
- rash, and
- increased sun sensitivity.
Serious side effects of Soriatane include:
- birth defects,
- liver toxicity,
- dry eyes,
- pseudotumor cerebri (increased pressure of the fluid in the brain), and
- skeletal abnormalities.
Soriatane reduces the effect of the microdose progestin minipill.
Soriatane should not be combined with methotrexate due to increased risk of liver failure.
Combining tetracycline with Soriatane increases intracranial pressure.
If phototherapy also is being used as treatment, the doses of phototherapy should be reduced to avoid excessive burning of the skin.
Soriatane is harmful to a fetus and it must not be used during pregnancy. Women must use 2 effective forms of birth control simultaneously for at least 1 month prior to starting Soriatane therapy, during therapy, and for at least 3 years after stopping treatment.
What are the important side effects of Soriatane (acitretin)?
Common side effects of Soriatane include:
- Inflammation of the lips (cheilitis)
- Hair loss
- Increased triglyceride levels
- Skin peeling
- Dry skin (25%-50%)
- Cold symptoms
- Joint pain
- Dry mouth
Other side effects of Soriatane include:
- Increased levels of liver enzymes
- Changes in phosphorus, potassium, sodium, and magnesium levels
- Increased sun sensitivity
Other less common side effects of Soriatane include:
- Water retention
- Increased appetite
- Possible serious side effects include:
- Birth defects (Please see the pregnancy and breastfeeding safety section.)
- Liver toxicity
- Dry eyes (xerophthalmia)
- Pseudotumor cerebri (increased pressure of the fluid in the brain)
- Skeletal abnormalities
Since acitretin can cause liver damage, liver function tests should be performed before treatment at 1- to 2-week intervals until stable, and thereafter at intervals as clinically needed
Soriatane (acitretin) side effects list for healthcare professionals
Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of Soriatane resemble those of the hypervitaminosis A syndrome.
Adverse Events/Postmarketing Reports
In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of Soriatane. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System: Myopathy with peripheral neuropathy has been reported during therapy with Soriatane. Both conditions improved with discontinuation of the drug.
Psychiatric: Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking Soriatane. Since other factors may have contributed to these events, it is not known if they are related to Soriatane.
Reproductive: Vulvo-vaginitis due to Candida albicans.
Skin and Appendages: Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported.
Vascular Disorders: Capillary leak syndrome.
During clinical trials with Soriatane, 513 of 525 (98%) subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, Soriatane was associated with elevations in liver function test results or triglyceride levels and hepatitis.
The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.
Table 3. Adverse Events Frequently Reported during Clinical Trials Percent of Subjects Reporting (N = 525)
|Body System||>75%||50% to 75%||25% to 50%||10% to 25%|
|Mucous Membranes||Cheilitis||Rhinitis||Dry mouth|
Spinal hyperostosis (progression of existing lesions)
|Skin and Appendages||Alopecia Skin peeling||Dry skin Nail disorder|
Table 4. Adverse Events Less Frequently Reported during Clinical Trials (Some of Which May Bear No Relationship to Therapy) Percent of Subjects Reporting (N = 525)
|Body System||1% to 10%||<1%|
|Body as a Whole||Anorexia|
Increased bleeding time
|CNS (also see Psychiatric)||Headache Pain||Abnormal gait|
|Pseudotumor cerebri (intracranial hypertension)|
|Eye Disorders||Abnormal/ blurred vision|
Corneal epithelial abnormality
|Decreased night vision/night blindness|
|Itchy eyes and lids|
Subepithelial corneal lesions
|Liver and Biliary||Hepatic function abnormal|
Gingivitis Increased saliva
Peripheral joint hyperostosis (progression of existing lesions)
Spinal hyperostosis (new lesions)
|Skin and Appendages||Abnormal skin odor|
Abnormal hair texture
Sweat gland disorder
|Special Senses/ Other||Earache|
Therapy with Soriatane induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 subjects treated with Soriatane. In most subjects, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In subjects receiving Soriatane during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40%. Transient, usually reversible elevations of alkaline phosphatase have been observed.
Table 5 lists the laboratory abnormalities reported during clinical trials.
Table 5. Abnormal Laboratory Test Results Reported during Clinical Trials Percent of Subjects Reporting
|Body System||50% to 75%||25% to 50%||10% to 25%||1% to 10%|
|Miscellaneous||Increased:||Increased:||Decreased:||Increased and decreased:|
|Urinary||WBC in urine||Acetonuria Hematuria RBC in urine||Glycosuria Proteinuria|
What drugs interact with Soriatane (acitretin)?
Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol.
In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with Soriatane is recommended.
It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin “minipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with Soriatane. It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated.
If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.
Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated.
Vitamin A And Oral Retinoids
Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A.
There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
Soriatane (acitretin) is a retinoid used to treat severe psoriasis in adults. Soriatane should be prescribed only by doctors who have experience in the systemic use of retinoids because it has serious side effects. Common side effects of Soriatane include inflammation of the lips, hair loss, increased triglyceride levels, skin peeling, dry skin, itching, cold symptoms, joint pain, and dry mouth. Other side effects of Soriatane include increased levels of liver enzymes; changes in phosphorus, potassium, sodium, and magnesium levels; nosebleeds, rash, and increased sun sensitivity. Soriatane is harmful to a fetus and it must not be used during pregnancy. Women must use 2 effective forms of birth control simultaneously for at least 1 month prior to starting Soriatane therapy, during therapy, and for at least 3 years after stopping treatment. Soriatane should not be used by women who are breastfeeding because it can pass into breast milk and harm the infant.
Multimedia: Slideshows, Images & Quizzes
Psoriasis Quiz: Test Your Medical IQ
Take the mystery out of psoriasis. Take the Psoriasis Quiz and see what you know about the types, symptoms, treatments and more.
Picture of Psoriasis 1
A reddish, scaly rash often located over the surfaces of the elbows, knees, scalp, and around or in the ears, navel, genitals or...
Picture of Psoriasis 2
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Picture of Psoriasis 3
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Picture of Inverse Psoriasis
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Picture of Pustular Psoriasis
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Picture of Erythrodermic Psoriasis
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Related Disease Conditions
Psoriasis is a long-term skin condition that may cause large plaques of red, raised skin, flakes of dry skin, and skin scales. There are several types of psoriasis, including psoriasis vulgaris, guttate psoriasis, inverse psoriasis, and pustular psoriasis. Symptoms vary depending on the type of psoriasis the patient has. Treatment of psoriasis may include creams, lotions, oral medications, injections and infusions of biologics, and light therapy. There is no cure for psoriasis.
Scalp Psoriasis (Psoriasis of the Scalp)
Scalp psoriasis causes red, raised, scaly patches that may extend from the scalp to the forehead and the back of the neck and ears. Symptoms and signs include itching, hair loss, flaking, silvery scales, and red plaques. Treatment includes topical medicated shampoos, creams, gels, oils, ointments, and soaps, medications, and light therapy.
Is Psoriasis Contagious?
Psoriasis is an incurable skin disease that causes reddish patches of skin topped with a thick layer of dry silvery scales. Psoriasis cannot spread and is not contagious.
What Is the Best Treatment for Psoriasis?
Psoriasis is an incurable chronic autoimmune disorder of the skin that causes patches of thick, flaky, scaly skin, mostly around the scalp, knees, and elbows, though any skin surface may be involved. Some people experience only small patches while others have red, inflamed skin and think scaly patches all over the body. The exact cause of psoriasis is not clear, but it isn’t contagious.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.