Soriatane

Last updated on RxList: 3/8/2021
Soriatane Side Effects Center

What Is Soriatane?

Soriatane (acitretin) is a retinoid, which is a form of vitamin A, used to treat severe psoriasis in adults. Soriatane is usually given after other psoriasis medicines have been unsuccessful. Soriatane is not a cure for psoriasis, and you may relapse after you stop taking this medication.

What Are Side Effects of Soriatane?

Common side effects of Soriatane include:

  • redness
  • itching
  • skin scaling
  • peeling
  • dry skin
  • sticky feeling on the skin the first several weeks as your body adjusts to the medication

 Other side effects of Soriatane include:

  • dry eyes
  • eye irritation
  • crusting of the eye lids
  • chapped or peeling skin
  • increased sensitivity to sunlight
  • dry mouth
  • peeling of the skin of fingertips/palms/soles of feet
  • weak nails
  • fragile skin
  • chapped lips
  • dry or runny nose
  • nosebleeds
  • thirst
  • taste changes
  • hair loss
  • headache
  • muscle tightness
  • nausea
  • stomach pain
  • diarrhea
  • flushing (warmth, redness, or tingly feeling)
  • sleep problems (insomnia)
  • ringing in your ears

What Are Side Effects of Soriatane?

Dosage for Soriatane

The starting dose of Soriatane is a single dose of 25 to 50 mg per day, with a meal. Maintenance doses of 25 to 50 mg per day may be given.

What Drugs, Substances, or Supplements Interact with Soriatane?

Soriatane may interact with phenytoin or St. John's wort. Other drugs may interact with Soriatane. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Soriatane During Pregnancy and Breastfeeding

Soriatane must not be used during pregnancy. 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 forms of birth control starting 1 month before and during treatment and at least 3 years after use has stopped. Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor. It is unknown if this drug is excreted into breast milk. Breastfeeding is not recommended while using this medication and for at least three years after the medication has been stopped.

Additional Information

Our Soriatane (acitretin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Soriatane Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using acitretin and call your doctor at once if you have:

  • mood changes--depression, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
  • heart attack or stroke symptoms--chest pain, dizziness, nausea, feeling short of breath, sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or balance, swelling or warmth in one or both legs;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision;
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
  • liver problems--nausea, vomiting, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes);
  • problems with your bones or muscles--loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones;
  • serious skin problems--itching, redness, pain, swelling or peeling of your skin; or
  • signs of a blood vessel problem--sudden swelling, rapid weight gain, fever, muscle pain, feeling light-headed.

Common side effects may include:

  • chapped lips, dry mouth;
  • itchy or scaly skin;
  • weak nails, fragile skin;
  • peeling skin on your hands and feet;
  • hair loss;
  • dry eyes, discomfort while wearing contact lenses;
  • dry or runny nose, nosebleeds; or
  • joint pain, tight muscles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Soriatane (Acitretin)

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Soriatane Professional Information

SIDE EFFECTS

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.

Cardiovascular

Acute myocardial infarction, thromboembolism (see WARNINGS), stroke.

Immune System Disorders

Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS).

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 (see PRECAUTIONS).

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 (see WARNINGS).

Vascular Disorders

Capillary leak syndrome (see WARNINGS).

Clinical Trials

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%
CNS Rigors
Eye Disorders Xerophthalmia
Mucous Membranes Cheilitis Rhinitis Dry mouth Epistaxis
Musculoskeletal Arthralgia
Spinal hyperostosis (progression of existing lesions)
Skin and Appendages Alopecia
Skin peeling
Dry skin
Nail disorder
Pruritus
Erythematous rash Hyperesthesia
Paresthesia
Paronychia
Skin atrophy
Sticky skin

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 Alcohol Malaise
Edema intolerance Moniliasis
Fatigue Dizziness Muscle weakness
Hot flashes Fever Weight increase
Increased appetite Influenza-like symptoms
Cardiovascular Flushing Chest pain Cyanosis Increased bleeding time Intermittent claudication
Peripheral ischemia
CNS (also see Psychiatric) Headache
Pain
Abnormal gait Migraine Neuritis Pseudotumor cerebri (intracranial hypertension)
Eye Disorders Abnormal/ blurred vision
Blepharitis
Conjunctivitis/ irritation
Corneal epithelial abnormality
Decreased night vision/night blindness
Eye abnormality
Eye pain
Photophobia
Abnormal lacrimation Chalazion Conjunctival hemorrhage Corneal ulceration Diplopia Ectropion Itchy eyes and lids
Papilledema
Recurrent sties
Subepithelial corneal lesions
Gastrointestinal Abdominal pain
Diarrhea
Nausea
Tongue disorder
Constipation
Dyspepsia
Esophagitis
Gastritis
Gastroenteritis
Glossitis
Hemorrhoids
Melena
Tenesmus
Tongue ulceration
Liver and Biliary Hepatic function abnormal
Hepatitis
Jaundice
Mucous Membranes Gingival bleeding
Gingivitis
Increased saliva
Stomatitis
Thirst
Ulcerative stomatitis
Altered saliva
Anal disorder
Gum hyperplasia
Hemorrhage
Pharyngitis
Musculoskeletal Arthritis
Arthrosis
Back pain
Hypertonia
Myalgia
Osteodynia
Peripheral joint hyperostosis (progression of existing lesions)
Bone disorder
Olecranon bursitis
Spinal hyperostosis (new lesions)
Tendonitis
Psychiatric Depression
Insomnia
Somnolence
Anxiety
Dysphonia
Libido decreased
Nervousness
Reproductive Atrophic vaginitis
Leukorrhea
Respiratory Sinusitis Coughing
Increased sputum
Laryngitis
Skin and Appendages Abnormal skin odor Abnormal hair texture
Bullous eruption
Cold/clammy skin
Dermatitis
Increased sweating
Infection
Psoriasiform rash
Purpura
Pyogenic granuloma Rash
Seborrhea
Skin fissures
Skin ulceration
Sunburn
Acne Breast pain
Cyst
Eczema
Fungal infection
Furunculosis
Hair discoloration
Herpes simplex
Hyperkeratosis
Hypertrichosis
Hypoesthesia
Impaired healing
Otitis media
Otitis externa
Photosensitivity reaction
Psoriasis aggravated
Scleroderma
Skin nodule
Skin hypertrophy
Skin disorder
Skin irritation
Sweat gland disorder
Urticaria
Verrucae
Special Senses/ Other Earache
Taste perversion
Tinnitus
Ceruminosis
Deafness
Taste loss
Urinary Abnormal urine
Dysuria
Penis disorder

Laboratory

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% (see WARNINGS). 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%
Electrolytes Increased:
-Phosphorus
-Potassium
-Sodium Increased and decreased:
-Magnesium
Decreased:
-Phosphorus
-Potassium
-Sodium Increased and decreased:
-Calcium
-Chloride
Hematologic Increased:
-Reticulocytes
Decreased:
-Hematocrit
-Hemoglobin
-WBC Increased:
-Haptoglobin
-Neutrophils
-WBC
Increased:
-Bands
-Basophils
-Eosinophils
-Hematocrit
-Hemoglobin
-Lymphocytes
-Monocytes Decreased:
-Haptoglobin
-Lymphocytes
-Neutrophils
-Reticulocytes Increased or decreased:
-Platelets
-RBC
Hepatic Increased:
-Cholesterol
-LDH
-SGOT
-SGPT Decreased:
-HDL cholesterol
Increased:
-Alkaline phosphatase
-Direct bilirubin
-GGTP
Increased:
-Globulin
-Total bilirubin
-Total protein Increased and decreased:
-Serum albumin
Miscellaneous Increased:
-Triglycerides
Increased:
-CPK
-Fasting blood sugar
Decreased:
-Fasting blood sugar
-High occult blood
Increased and decreased:
-Iron
Renal Increased:
-Uric acid
Increased:
-BUN
-Creatinine
Urinary WBC in urine Acetonuria Hematuria RBC in urine Glycosuria Proteinuria

DRUG INTERACTIONS

Ethanol

Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics).

Glyburide

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 (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).

Hormonal Contraceptives

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 (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.

Methotrexate

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 (see CONTRAINDICATIONS).

Phenytoin

If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.

Tetracyclines

Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see CONTRAINDICATIONS and WARNINGS: Pseudotumor Cerebri).

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.

Other

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.

Laboratory Tests

If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.

Blood Sugar

Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, bloodsugar levels should be monitored very carefully.

Lipids

In clinical trials, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33%, and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to SORIATANE has stabilized (see WARNINGS).

Liver Function Tests

Elevations of AST (SGOT), ALT (SGPT), or LDH were experienced by approximately 1 in 3 patients treated with SORIATANE. It is recommended that these tests be performed prior to initiation of therapy with SORIATANE, at 1- to 2-week intervals until stable, and thereafter at intervals as clinically indicated (see CONTRAINDICATIONS and boxed WARNINGS).

Read the entire FDA prescribing information for Soriatane (Acitretin)

© Soriatane Patient Information is supplied by Cerner Multum, Inc. and Soriatane Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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