Soriatane Side Effects

Generic Name: acitretin

Note: This page contains side effects data for the generic drug acitretin. It is possible that some of the dosage forms included below may not apply to the brand name Soriatane.

It is possible that some side effects of Soriatane may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to acitretin: oral capsule

As well as its needed effects, acitretin (the active ingredient contained in Soriatane) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking acitretin, check with your doctor immediately:

More common
  • Back pain
  • bad, unusual, or unpleasant (after) taste
  • bone or joint pain
  • change in taste
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty with moving or walking
  • excessive muscle tone
  • feeling of warmth
  • headache (severe and continuing)
  • hearing loss
  • increased sensitivity to pain
  • increased sensitivity to touch
  • muscle stiffness
  • muscle tension or tightness
  • nausea or vomiting (severe and continuing)
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • sleeplessness
  • stiff, painful muscles
  • thinning of the skin with easy bruising
  • tingling in the hands and feet
  • tongue irritation
  • trouble sleeping
  • unable to sleep
Less common
  • Acid or sour stomach
  • blurred vision
  • belching
  • breast pain
  • eye pain
  • eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of the eyes to light, or watery eyes
  • general feeling of discomfort or illness
  • heartburn
  • increased hair growth on the forehead, back, arms, and legs
  • indigestion
  • itching of the vagina or genital area
  • loosening of the fingernails
  • pain during sexual intercourse
  • redness or soreness around the fingernails
  • sore mouth or tongue
  • thick, white vaginal discharge with no odor or with a mild odor
  • white patches in the mouth or on the tongue
  • Abdominal or stomach pain
  • bleeding gums
  • bleeding time increased
  • chest pain
  • coughing, hoarseness, trouble in speaking, or flu-like symptoms
  • coughing up blood
  • darkened urine
  • diarrhea
  • difficulty in breathing or swallowing
  • double vision or other problems in seeing, including decreased night vision after sunset and before sunrise
  • increased menstrual flow or vaginal bleeding
  • itchy or painful ears
  • light-colored stools
  • nosebleeds
  • pale or cold hands or feet
  • paralysis
  • prolonged bleeding from cuts
  • red or dark brown urine
  • shortness of breath
  • skin problems, such as abnormal sensation of burning or stinging, cracking, redness, skin irritation or rash (including a rash that looks like psoriasis), infection, ulcers, unusual odor, or small red spots in the skin
  • sore on the edge of the eyelid (stye)
  • thick, white, curd-like vaginal discharge
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vaginal itching or irritation
  • vomiting of blood
  • yellowing of the skin or eyes
Incidence not known
  • Assault
  • attack
  • burning, numbness, tingling, or painful sensations
  • chest pain or discomfort
  • confusion
  • difficulty with breathing
  • difficulty with speaking
  • doing things to injure oneself
  • force
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • pain in the chest, groin, or legs, especially calves
  • pain or discomfort in the arms, jaw, back, or neck
  • shortness of breath
  • slow speech
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arms or legs
  • sudden, unexplained shortness of breath
  • sweating
  • thoughts of killing oneself
  • unsteadiness or awkwardness
  • vision changes
  • weakness in the arms, hands, legs, or feet

If any of the following symptoms of overdose occur while taking acitretin, get emergency help immediately:

Symptoms of overdose
  • Dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • sensation of spinning

Some acitretin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Chapped, red, or swollen lips
  • difficulty in wearing contact lenses
  • dry or runny nose
  • dryness of the eyes
  • increased ability to sunburn
  • increased amount of ear wax (unusual)
  • irritation in the mouth or swollen gums
  • itchy skin
  • loss of hair (usually reversible)
  • nosebleeds
  • scaling and peeling of the eyelids, fingertips, palms, and soles of feet
  • sticky skin
  • unusual thirst
Less common
  • Constipation
  • diarrhea
  • increased sweating
Incidence not known
  • Cracking fingernails or fingernails break easily
  • muscular pain, tenderness, wasting, or weakness

For Healthcare Professionals

Applies to acitretin: oral capsule, oral and topical kit


Very common (10% or more): Cheilitis (greater than 75%), dry mouth (10% to 25%)
Common (1% to 10%): Abdominal pain, diarrhea, nausea, tongue disorder, gingival bleeding, gingivitis, stomatitis, increased saliva, ulcerative stomatitis, taste perversion, taste loss
Uncommon (0.1% to 1%): Less than 1%: Constipation, dyspepsia, esophagitis, gastritis, gastroenteritis, glossitis, hemorrhoids, melena, tenesmus, tongue ulceration, altered saliva, anal disorder, gum hyperplasia
Rare (less than 0.1%): Pancreatitis, fatal fulminant pancreatitis (at least 1 case)
Frequency not reported: Vomiting


Very common (10% or more): Alopecia (50% to 75%), skin peeling (50% to 75%), dry skin (25% to 50%), nail disorder (25% to 50%), pruritus (25% to 50%), erythematous rash (10% to 25%), paronychia (10% to 25%), skin atrophy (10% to 25%), sticky skin (10% to 25%)
Common (1% to 10%): Abnormal skin odor, abnormal hair texture, bullous eruption, cold/clammy skin, dermatitis, increased sweating, skin infection, psoriasiform rash, purpura, pyogenic granuloma, rash, seborrhea, skin fissures, skin ulceration, sunburn
Uncommon (0.1% to 1%): Less than 1%: Acne, cyst, eczema, fungal infection, furunculosis, hair discoloration, herpes simplex, hyperkeratosis, hypertrichosis, impaired healing, photosensitivity reaction, psoriasis aggravated, scleroderma, skin nodule, skin hypertrophy, skin disorder, skin irritation, sweat gland disorder, urticaria, verrucae
Rare (less than 0.1%): Subungual hemorrhage (at least 1 case),acitretin-induced transverse leuconychia (at least 1 case)
Postmarketing reports: Thinning of skin, skin fragility and scaling (especially on the palms and soles), nail fragility


Very common (10% or more): Increased triglycerides (50% to 75%), increased cholesterol (25% to 50%), increased lactate dehydrogenase (25% to 50%), increased creatine phosphokinase (25% to 50%), increased fasting blood sugar (25% to 50%), decreased high-density lipoprotein cholesterol (25% to 50%), increased phosphorus (10% to 25%), increased potassium (10% to 25%), increased sodium (10% to 25%), increased and decreased magnesium (10% to 25%), decreased fasting blood sugar (10% to 25%), decreased high occult blood (10% to 25%)
Common (1% to 10%): Anorexia, increased appetite, decreased phosphorus, decreased potassium, decreased sodium, increased and decreased calcium, increased and decreased chloride, increased and decreased iron, increased globulin, increased total protein, decreased serum albumin


Very common (10% or more): Increased AST (SGOT; 25% to 50%), increased ALT (SGPT; 25% to 50%), increased alkaline phosphatase (10% to 25%), increased direct bilirubin (10% to 25%), increased gamma-glutamyltransferase (10% to 25%)
Common (1% to 10%): Increased total bilirubin
Uncommon (0.1% to 1%): Less than 1%: Hepatic function abnormal, hepatitis, jaundice
Frequency not reported: Abnormal liver function tests, hepatotoxicity

A prospective, 2-year, open-label, multicenter study of 128 adults treated with intermittent acitretin therapy for severe psoriasis, concluded that there was no conclusive evidence that acitretin elicited significant biopsy-proven hepatotoxicities. All of the subjects received a cumulative dose of approximately 32 g of acitretin and liver biopsies and liver function tests (LFTs) were performed before and after treatment. Of the 128 patients, 83 completed the trial and only 1 of the subjects developed worsening liver histological findings. Furthermore, the patient did not exhibit any signs of abnormal LFTs. The study concluded that there was no proven evidence linking abnormal LFTs or triglycerides to changes in liver biopsy with acitretin therapy.


Very common (10% or more): Increased reticulocytes (25% to 50%), decreased hematocrit (10% to 25%), decreased hemoglobin (10% to 25%), decreased white blood cells (10% to 25%), increased haptoglobin (10% to 25%), increased neutrophils (10% to 25%), increased white blood cells (10% to 25%)
Common (1% to 10%): Increased bands, increased basophils, increased eosinophils, increased hematocrit, increased hemoglobin, increased lymphocytes, increased monocytes, decreased haptoglobin, decreased lymphocytes, decreased neutrophils, decreased reticulocytes, increased or decreased platelets, increased or decreased red blood cells


Very common (10% or more): Rhinitis (25% to 50%), epistaxis (10% to 25%)
Common (1% to 10%): Sinusitis
Uncommon (0.1% to 1%): Less than 1%: Pharyngitis, coughing, increased sputum, laryngitis
Frequency not reported: Dyspnea


Very common (10% or more): White blood cells in urine (25% to 50%), acetonuria (10% to 25%), hematuria (10% to 25%), red blood cells in urine (10% to 25%)
Common (1% to 10%): Glycosuria (1% to 10%), proteinuria (1% to 10%)
Uncommon (0.1% to 1%): Less than 1%: Atrophic vaginitis, leukorrhea, dysuria, abnormal urine, penis disorder
Postmarketing reports: Vulvovaginitis due to Candida albicans


A case report of a 64-year-old man with severe erythrodermic psoriasis treated with acitretin (the active ingredient contained in Soriatane) developed myopathies in all four limbs after 14 days of acitretin therapy and was unable to walk or rise from a chair after 3 more days of treatment. He was previously treated with etretinate, methotrexate, and PUVA. Treatment prior to the myopathies consisted of emollient and clobetasol propionate cream followed by 50 mg/day of acitretin. Upon examination on day 14 of acitretin therapy, he showed edema of both forearms and complained of weakness in all four limbs. His creatinine phosphokinase was elevated to 3991 international units/L, C-reactive protein was elevated to 62.5 mg/L, and aldolase was 13.5 international units/L. Electromyography (EMG) showed severe myopathic changes and profuse fibrillation of both upper and lower limbs.

Acitretin was discontinued 15 days later; the myopathies spontaneously improved and the patient was able to walk 10 days after cessation of acitretin. Creatinine phosphokinase returned to baseline and EMG improved. The mechanism of myopathy is unclear but did not appear to involve inflammation or major structural muscle abnormalities.

Skeletal changes due to long-term use of acitretin have included degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, narrowing and destruction of cervical disc space, and phalanx bone resorption.

Very common (10% or more): Arthralgia (10% to 25%), spinal hyperostosis (progression of existing lesions; 10% to 25%)
Common (1% to 10%): Arthritis, myalgia, arthrosis, back pain, osteodynia, hypertonia, peripheral joint hyperostosis (progression of existing lesions)
Uncommon (0.1% to 1%): Less than 1%: Muscle weakness, bone disorder, olecranon bursitis, tendonitis, spinal hyperostosis (new lesions)
Frequency not reported: Bone pain, ligament calcification, osteoporosis, extraspinal calcifications, thinning of the long bones, myopathies, skeletal changes (including degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, narrowing and destruction of cervical disc space, phalanx bone resorption)
Postmarketing reports: Myopathy (with peripheral neuropathy)

Nervous system

Very common (10% or more): Rigors (10% to 25%), hyperesthesia (10% to 25%), paresthesia (10% to 25%)
Common (1% to 10%): Headache, tinnitus
Uncommon (0.1% to 1%): Less than 1%: Dizziness, neuritis, abnormal gait, pseudotumor cerebri (intracranial hypertension), migraine, hypoesthesia
Frequency not reported: Confusion
Postmarketing reports: Peripheral neuropathy (associated with myopathy)


Very common (10% or more): Xerophthalmia (10% to 25%)
Common (1% to 10%): Abnormal/blurred vision, conjunctivitis/irritation, decreased night vision/night blindness, blepharitis, corneal epithelial abnormality, eye abnormality, eye pain, photophobia
Uncommon (0.1% to 1%): Less than 1%: Papilledema, diplopia, recurrent sties, subepithelial corneal lesions, abnormal lacrimation, chalazion, conjunctival hemorrhage, corneal ulceration, ectropion, itchy eyes and lids
Frequency not reported: Blepharoconjunctivitis, excess granulation tissue on palpebral conjunctivae


Very common (10% or more): Increased uric acid (10% to 25%)
Common (1% to 10%): Increased BUN, increased creatinine


Common (1% to 10%): Depression, insomnia, somnolence
Uncommon (0.1% to 1%): Less than 1%: Nervousness, anxiety, dysphonia, decreased libido
Postmarketing reports: Aggressive feelings, suicidal thoughts, self-injurious behavior


Common (1% to 10%): Edema, fatigue, hot flashes, flushing, pain, thirst, earache
Uncommon (0.1% to 1%): Less than 1%: Alcohol intolerance, fever, influenza-like symptoms, malaise, moniliasis, weight increase, mucous membrane hemorrhage, breast pain, otitis media, otitis externa, ceruminosis, deafness
Frequency not reported: Mucosal dryness, peripheral edema, retinoic acid syndrome


Uncommon (0.1% to 1%): Less than 1%: Chest pain, cyanosis, increased bleeding time, intermittent claudication, peripheral ischemia
Rare (less than 0.1%): Thrombogenic stroke (at least 1 case), capillary leak syndrome (at least 1 case)
Frequency not reported: Arrhythmias
Postmarketing reports: Acute myocardial infarction, stroke, thromboembolism

A case report of a 52-year-old postmenopausal female who suffered a thrombogenic stroke after thirty-four days of 50 mg/day acitretin therapy was reported. The woman had also been treated with clomipramine 25 mg every 2 to 3 days for the past 17 years. She had no previous history of hypertension, tobacco use, high cholesterol, diabetes, or other risk factors or traumatic/infectious disease. No previous cases of thrombosis or thrombogenic events caused by acitretin therapy had been reported although thrombotic events have been attributed to the use of tretinoin. The exact role retinoids play in the coagulation scheme is difficult to identify, however the pharmacologic pathology of acitretin cannot be excluded as the possible cause of the thrombotic stroke.

One isolated case of capillary leak syndrome (CLS) induced by acitretin was reported although the pathophysiology of edema is poorly explained. However, delayed-type hypersensitivity could contribute to the syndrome. CLS has been reported in association with erythrodermic psoriasis, Ofuji's papuloerythroderma, monoclonal antibodies, and treatment with cytostatic drugs including all trans-retinoic acids. Edema, which is a clinical manifestation of CLS and a known complication of hypervitaminosis A, has been associated with retinoids and slowly regresses after discontinuation of therapy.

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