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Soriatane Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Soriatane (acitretin) is used to treat severe psoriasis in adults. It is usually given after other psoriasis medicines have been unsuccessful. It is not a cure for psoriasis, and you may relapse after you stop taking this medication. Soriatane is a retinoid, which is a form of vitamin A. Common side effects include 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, increased sensitivity to sunlight, 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.
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. Breast-feeding 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Soriatane in Detail - Patient Information: Side Effects
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.
Read the entire detailed patient monograph for Soriatane (Acitretin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Soriatane Overview - Patient Information: Side Effects
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, increased sensitivity to sunlight, 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, change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: mood changes (e.g., depression, aggressive or violent behavior, and in rare cases thoughts of suicide).
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Soriatane (Acitretin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Soriatane FDA Prescribing 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.
Immune System Disorders
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).
Capillary leak syndrome (see WARNINGS).
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 =
|Body System||> 75%||50% to 75%||25% to 50%||10% to 25%|
|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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