Skip to main content

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, 513/525 (98%) of 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% to10% < 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: -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