SORIATANE SIDE EFFECTS

  • Generic Name: acitretin
  • Brand Name: Soriatane
  • Drug Class: Retinoid-like Agents, Topical, Antipsoriatics, Systemic
Last updated on MDtodate: 10/03/2022

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)
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
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%. 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
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

 

 

SRC: NLM .