What is Soriatane (acitretin)?

Soriatane (acitretin) is a retinoid used to treat severe psoriasis in adults. Soriatane should be prescribed only by doctors who have experience in the systemic use of retinoids because it has serious side effects.

Common side effects of Soriatane include:

Other side effects of Soriatane include:

  • increased levels of liver enzymes;
  • changes in phosphorus, potassium, sodium, and magnesium levels;
  • nosebleeds,
  • rash, and
  • increased sun sensitivity.

Serious side effects of Soriatane include:

Drug interactions of Soriatane include alcohol, which increases conversion of acitretin to etretinate, which remains in the body much longer and is also harmful to a fetus. 

Soriatane may increase the effects of glyburide on blood glucose and potentially cause hypoglycemia

Soriatane reduces the effect of the microdose progestin minipill. 

Soriatane should not be combined with methotrexate due to increased risk of liver failure. 

Combining tetracycline with Soriatane increases intracranial pressure. 

Taking vitamin A supplements may increase side effects of Soriatane. 

If phototherapy also is being used as treatment, the doses of phototherapy should be reduced to avoid excessive burning of the skin. 

Soriatane is harmful to a fetus and it must not be used during pregnancy. Women must use 2 effective forms of birth control simultaneously for at least 1 month prior to starting Soriatane therapy, during therapy, and for at least 3 years after stopping treatment. 

Soriatane should not be used by women who are breastfeeding because it can pass into breast milk and harm the infant.

What are the important side effects of Soriatane (acitretin)?

Common side effects of Soriatane include:

Other side effects of Soriatane include:

  • Increased levels of liver enzymes
  • Changes in phosphorus, potassium, sodium, and magnesium levels
  • Nosebleeds
  • Rash
  • Increased sun sensitivity

Other less common side effects of Soriatane include:

Since acitretin can cause liver damage, liver function tests should be performed before treatment at 1- to 2-week intervals until stable, and thereafter at intervals as clinically needed

Soriatane (acitretin) side effects list for healthcare professionals

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 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%
CNSRigors
Eye DisordersXerophthalmia
Mucous MembranesCheilitisRhinitisDry mouth
Epistaxis
MusculoskeletalArthralgia
Spinal hyperostosis (progression of existing lesions)
Skin and AppendagesAlopecia Skin peelingDry 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 System1% to 10%<1%
Body as a WholeAnorexia
Edema
Fatigue
Hot flashes
Increased appetite
Alcohol intolerance
Dizziness
Fever
Influenza-like symptoms
Malaise
Moniliasis
Muscle weakness
Weight increase
CardiovascularFlushingChest pain
Cyanosis
Increased bleeding time
Intermittent claudication
Peripheral ischemia
CNS (also see Psychiatric)Headache PainAbnormal gait
Migraine Neuritis
Pseudotumor cerebri (intracranial hypertension)
Eye DisordersAbnormal/ 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
GastrointestinalAbdominal pain
Diarrhea
Nausea
Tongue disorder
Constipation
Dyspepsia
Esophagitis
Gastritis
Gastroenteritis
Glossitis
Hemorrhoids
Melena
Tenesmus
Tongue ulceration
Liver and BiliaryHepatic function abnormal
Hepatitis
Jaundice
Mucous
Membranes
Gingival bleeding
Gingivitis Increased saliva
Stomatitis
Thirst
Ulcerative stomatitis
Altered saliva
Anal disorder
Gum hyperplasia
Hemorrhage
Pharyngitis
MusculoskeletalArthritis
Arthrosis
Back pain
Hypertonia
Myalgia
Osteodynia
Peripheral joint hyperostosis (progression of existing lesions)
Bone disorder
Olecranon bursitis
Spinal hyperostosis (new lesions)
Tendonitis
PsychiatricDepression
Insomnia
Somnolence
Anxiety
Dysphonia
Libido decreased
Nervousness
ReproductiveAtrophic vaginitis
Leukorrhea
RespiratorySinusitisCoughing
Increased sputum
Laryngitis
Skin and AppendagesAbnormal 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/ OtherEarache
Taste perversion
Tinnitus
Ceruminosis
Deafness
Taste loss
UrinaryAbnormal 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 5 lists the laboratory abnormalities reported during clinical trials.

Table 5. Abnormal Laboratory Test Results Reported during Clinical Trials Percent of Subjects Reporting

Body System50% to 75%25% to 50%10% to 25%1% to 10%
ElectrolytesIncreased:
  • Phosphorus
  • Potassium
  • Sodium
Increased and decreased:
  • Magnesium
Decreased:
  • Phosphorus
  • Potassium
  • Sodium
Increased and decreased:
  • Calcium
  • Chloride
HematologicIncreased:
  • 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
HepaticIncreased:
  • Cholesterol
  • LDH
  • SGOT
  • SGPT
Decreased:
  • HDL cholesterol
Increased:
  • Alkaline phosphatase
  • Direct bilirubin
  • GGTP
Increased:
  • Globulin
  • Total bilirubin
  • Total protein
Increased and decreased:
  • Serum albumin
MiscellaneousIncreased:
  • Triglycerides
Increased:
  • CPK
  • Fasting blood sugar
Decreased:
  • Fasting blood sugar
  • High occult blood
Increased and decreased:
  • Iron
RenalIncreased:
  • Uric acid
Increased:
  • BUN
  • Creatinine
UrinaryWBC in urineAcetonuria Hematuria RBC in urineGlycosuria Proteinuria

What drugs interact with Soriatane (acitretin)?

Ethanol

Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol.

Glyburide

In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with Soriatane is recommended.

Hormonal Contraceptives

It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin “minipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with Soriatane. It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.

Methotrexate

An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated.

Phenytoin

If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.

Tetracyclines

Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated.

Vitamin A And Oral Retinoids

Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A.

Other

There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Summary

Soriatane (acitretin) is a retinoid used to treat severe psoriasis in adults. Soriatane should be prescribed only by doctors who have experience in the systemic use of retinoids because it has serious side effects. Common side effects of Soriatane include inflammation of the lips, hair loss, increased triglyceride levels, skin peeling, dry skin, itching, cold symptoms, joint pain, and dry mouth. Other side effects of Soriatane include increased levels of liver enzymes; changes in phosphorus, potassium, sodium, and magnesium levels; nosebleeds, rash, and increased sun sensitivity. Soriatane is harmful to a fetus and it must not be used during pregnancy. Women must use 2 effective forms of birth control simultaneously for at least 1 month prior to starting Soriatane therapy, during therapy, and for at least 3 years after stopping treatment. Soriatane should not be used by women who are breastfeeding because it can pass into breast milk and harm the infant.

Treatment & Diagnosis

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Medically Reviewed on 5/15/2020
References
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Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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