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Last reviewed on RxList: 9/11/2015
Soriatane Side Effects Center

Last reviewed on RxList 8/5/2016

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. 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

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. 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 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.

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.

Soriatane Consumer Information

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

Stop using acitretin and call your doctor at once if you have a serious side effect such as:

  • blurred vision, headache or pain behind your eyes, sometimes with nausea and vomiting;
  • sudden decrease in night vision;
  • depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
  • jaundice (yellowing of the skin or eyes);
  • loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones;
  • mouth sores, swollen or bleeding gums;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • chest pain or heavy feeling, spreading to the arm or shoulder, sweating, shortness of breath;
  • sudden severe headache, confusion, problems with speech or balance, numbness or weakness (especially on one side of the body);
  • sudden cough, wheezing, rapid breathing, fast heart rate; or
  • pain, swelling, warmth, or redness in one or both legs.

Less serious side effects may include:

  • dry eyes, chapped or peeling skin, hair loss;
  • itching, scaling, or sticky feeling on your skin;
  • weak nails, fragile skin;
  • dry mouth, dry or runny nose, nosebleeds;
  • mild headache, muscle tightness;
  • nausea, stomach pain, diarrhea;
  • flushing (warmth, redness, or tingly feeling);
  • sleep problems (insomnia); or
  • ringing in your ears.

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)

Soriatane Professional Information


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.


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.


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).


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 Edema Fatigue Hot flashes Increased appetite   Alcohol intolerance Dizziness Fever Influenza-like symptoms Malaise Moniliasis Muscle weakness Weight increase
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  


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

Read the entire FDA prescribing information for Soriatane (Acitretin)

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© 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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