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Soriatane

Last reviewed on RxList: 10/16/2017
Soriatane Side Effects Center

Last reviewed on RxList 10/16/2017

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

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
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
 

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: Increased and decreased:
  • Magnesium
Decreased:
  • Phosphorus
  • Potassium
  • Sodium
Increased and decreased:
  • Calcium
  • Chloride
Hematologic   Increased:
  • Reticulocytes
Decreased: 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:
Increased:
  • Alkaline phosphatase
  • Direct bilirubin
  • GGTP
Increased:
  • Globulin
  • Total bilirubin
  • Total protein
Increased and decreased:
Miscellaneous Increased:
  • Triglycerides
Increased:
  • CPK
  • Fasting blood sugar
Decreased:
  • Fasting blood sugar
  • High occult blood
Increased and decreased:
  • Iron
Renal     Increased: Increased:
  • BUN
  • Creatinine
Urinary   WBC in urine Acetonuria Hematuria RBC in urine Glycosuria Proteinuria

Read the entire FDA prescribing information for Soriatane (Acitretin)

Related Resources for Soriatane

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Read the Soriatane User Reviews »

© 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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