Soriatane Side Effects

Generic Name: acitretin

Please note - some side effects for Soriatane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Soriatane - for the Consumer

Soriatane

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Soriatane:

Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; red, blistered, swollen skin; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; vaginal itching, odor, or discharge; yellowing of the skin or eyes.

Soriatane CK

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Soriatane CK:

Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; red, blistered, swollen skin; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; vaginal itching, odor, or discharge; yellowing of the skin or eyes.

Soriatane Side Effects - for the Professional

Soriatane

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 Soriatane Capsules administration 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 Capsules. 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 casual relationship to drug exposure.

Acute myocardial infarction, thromboembolism, stroke.

Myopathy with peripheral neuropathy has been reported during Soriatane Capsules therapy. Both conditions improved with discontinuation of the drug.

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 Capsules. Since other factors may have contributed to these events, it is not known if they are related to Soriatane Capsules.

Vulvo-vaginitis due to Candida albicans

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.

Clinical Trials

During clinical trials with Soriatane Capsules, 513/525 (98%) of patients reported a total of 3545 adverse events. One-hundred sixteen patients (22%) left studies prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three patients died. Two of the deaths were not drug related (pancreatic adenocarcinoma and lung cancer); the other patient died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, Soriatane Capsules 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 patients with psoriasis.

Laboratory

Soriatane Capsules therapy 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 patients treated with Soriatane Capsules. In most patients, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In patients receiving Soriatane Capsules 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.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included cheilitis (greater than 75%) and dry mouth (10% to 25%). Other less common side effects that have been reported are gingivitis, stomatitis, gum hyperplasia, anorexia, increased appetite, abdominal pain, diarrhea, nausea, vomiting, gastroenteritis, constipation, dyspepsia, gastritis, pharyngitis, glossitis, tongue disorder, esophagitis, hemorrhoids, melena, tenesmus, increased saliva, ulcerative stomatitis, altered saliva, anal disorder, and tongue ulceration. Pancreatitis and at least one case of fatal fulminant pancreatitis have been reported.

Dermatologic

Dermatologic side effects have included alopecia and skin peeling (50% to 75%); dry skin, nail disorder, and pruritus (25% to 50%); and erythematous rash, paronychia, skin atrophy, and sticky skin (10% to 25%). Abnormal skin odor, abnormal hair texture, bullous eruption, cold/clammy skin, dermatitis, increased sweating, psoriasiform rash, purpura, pyogenic granuloma, rash, seborrhea, skin fissures, skin ulceration, and sunburn have been reported in 1% to 10% of patients during clinical trials, regardless of causality. Acne, cyst, eczema, furunculosis, hair discoloration, hyperkeratosis, hypertrichosis, impaired healing, photosensitivity reaction, psoriasis aggravated, scleroderma, skin nodule, skin hypertrophy, skin disorder, skin irritation, sweat gland disorder, urticaria, and verruca have been reported in less than 1% of patients during clinical trials, regardless of causality. At least one case of subungual hemorrhage has been reported. Thinning of skin, skin fragility and scaling (especially on the palms and soles), and nail fragility have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included increased triglycerides (50% to 75%) and increased CPK and fasting blood sugar (25% to 50%). Increased phosphorus, potassium, and sodium; increased and decreased magnesium; and decreased fasting blood sugar and high occult blood have been reported in 10% to 25% of patients during clinical trials. Decreased phosphorus, potassium, and sodium and increased and decreased calcium, chloride, and iron have been reported in 1% to 10% of patients during clinical trials. Elevated cholesterol, decreased high-density lipoprotein cholesterol, and increased weight have also been reported.

Hepatic

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.

Hepatic side effects have included abnormal liver function tests, hepatotoxicity, hepatitis, and jaundice. An increase in cholesterol, LDH, AST (SGOT), and ALT (SGPT) and a decrease in HDL is reported in 25% to 50% of patients during clinical trials. In 10% to 25% of patients during clinical trials, an increase in alkaline phosphatase, direct bilirubin, and GGTP was observed. In 1% to 10% of patients during clinical trials, an increase in globulin, total bilirubin and total protein and a decrease in serum albumin was observed.

Hematologic

Hematologic side effects have included increased reticulocytes (25% to 50%), decreased hematocrit (10% to 25%), decreased hemoglobin (10% to 25%), decreased and increased white blood cells (10% to 25%), increased haptoglobin (10% to 25%), and increased neutrophils (10% to 25%). An increase in bands, basophils, eosinophils, hematocrit, hemoglobin, and monocytes and a decrease in haptoglobin, neutrophils, and reticulocytes have been reported in 1% to 10% of patients during clinical trials. Increased or decreased lymphocytes, platelets, and red blood cells have been seen in 1% to 10% of patients during clinical trials.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, hyperostosis (including spinal and peripheral joint), arthritis, myalgia, myopathy (including with peripheral neuropathy), muscle weakness, arthrosis, osteodynia, hypertonia, olecranon bursitis, bone pain, back pain, bone disorder, tendonitis, and ligament calcification. Other musculoskeletal side effects are osteoporosis, extraspinal calcifications, and thinning of the long bones. A detailed case report of myopathies was recorded in conjunction with acitretin therapy. 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.

A case report of a 64-year-old man with severe erythrodermic psoriasis treated with acitretin 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.

Ocular

Ocular side effects have included xerophthalmia, eye irritation/conjunctivitis, impaired vision and night vision (including night blindness), blepharitis, corneal epithelial abnormalities, eye abnormalities, eye pain, blurred vision, abnormal vision, and photophobia. Other less common ocular side effects have included papilledema, diplopia, recurrent styes, subepithelial corneal lesions, abnormal lacrimation, chalazion, conjunctival hemorrhage, corneal ulceration, ectropion, and itchy eyes and lids. Blepharoconjunctivitis and excess granulation tissue on palpebral conjunctivae have been reported.

Nervous system

Nervous system side effects have included rigors, headache, pain, hyperesthesia, paresthesia, neuritis, dizziness, abnormal gait, pseudotumor cerebri, migraine, hypoesthesia, and confusion.

Cardiovascular

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-retionic 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.

Cardiovascular side effects have included flushing, chest pain, arrhythmias, cyanosis, increased bleeding, intermittent claudication, and peripheral ischemia. Acute myocardial infarction, stroke, and thromboembolism have been reported during postmarketing experience. At least one case report detailing acitretin as a probable cause of a thrombogenic stroke had been recorded. There is at least one record of Capillary Leak Syndrome (CLS) in association with acitretin therapy.

Psychiatric

Psychiatric side effects have included suicidal thoughts, aggressive feelings, depression, insomnia, somnolence, nervousness, anxiety, and dysphonia. Self-injurious behavior has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included rhinitis (25% to 50%) and epistaxis (10% to 25%). Other respiratory side effects reported include dyspnea, sinusitis, coughing, increased sputum, and laryngitis.

Genitourinary

Genitourinary side effects have included white blood cells in urine (25% to 50%); acetonuria, hematuria, and red blood cells in urine (10% to 25%); glycosuria and proteinuria (1% to 10%); and atrophic vaginitis, leukorrhea, dysuria, abnormal urine, penis disorder, and decreased libido (less than 1%).

Renal

Renal side effects have included increased uric acid (10% to 25%), BUN (1% to 10%), and creatinine (1% to 10%).

Other

Other side effects have included fatigue, alcohol intolerance, fever, influenza-like symptoms, malaise, mucosal dryness, hot flashes, peripheral edema, earache, taste perversion, ceruminosis, deafness, taste loss, thirst, mucous membrane hemorrhage, tinnitus, and breast pain.

Immunologic

Immunologic side effects have included fungal infection, herpes simplex, infection, moniliasis, otitis media, and otitis externa. Vulvovaginitis due to Candida albicans has been reported during postmarketing experience.

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