SORIATANE SIDE EFFECTS
- Generic Name: acitretin
- Brand Name: Soriatane
- Drug Class: Retinoid-like Agents, Topical, Antipsoriatics, Systemic
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, stroke.
Immune System Disorders
Hypersensitivity, including angioedema and urticaria.
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.
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 1: 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) |
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| Skin and Appendages | Alopecia Skin peeling |
Dry skin Nail disorder Pruritus |
Erythematous rash Hyperesthesia Paresthesia Paronychia Skin atrophy Sticky skin |
Table 2: 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 |
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| 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 |
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| Reproductive | Atrophic vaginitis Leukorrhea |
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| Respiratory | Sinusitis | Coughing Increased sputum Laryngitis |
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| 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 |
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| Urinary | Abnormal urine Dysuria Penis disorder |
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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%. Transient, usually reversible elevations of alkaline phosphatase have been observed.
Table 3 lists the laboratory abnormalities reported during clinical trials.
Table 3. 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 |
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| 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 |
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| Urinary | WBC in urine | Acetonuria Hematuria RBC in urine | Glycosuria Proteinuria |
SRC: NLM .