Note: This document contains side effect information about acitretin. Some dosage forms listed on this page may not apply to the brand name Soriatane.
Summary
Common side effects of Soriatane include: increased gamma-glutamyl transferase and xerophthalmia. Other side effects include: eye irritation. Continue reading for a comprehensive list of adverse effects.
Applies to acitretin: oral capsule.
Warning
Oral route (Capsule)
Acitretin, the active metabolite of etretinate, is teratogenic and major fetal abnormalities have been reported during and after treatment completion. Use in women should be reserved for non-pregnant patients with severe psoriasis that did not respond to alternative treatments or when alternative treatments are contraindicated. Acitretin is contraindicated in women of childbearing potential unless all of the following criteria are met: 1) two negative urine or serum pregnancy tests (sensitivity at least 25 milli-international units/mL) prior to initiation; the first test is a screen test, the second test is a confirmation test done during first 5 days of menstrual period before therapy initiation or done at least 11 days after unprotected sex in amenorrhea patients; initiate treatment within 7 days of second negative pregnancy test; prescription for acitretin is limited to a 1 month supply; 2) pregnancy test must be repeated every month during treatment with a sensitivity of at least 25 milli-international units/mL and test result must be negative before receiving a prescription for the month; after discontinuing therapy, a pregnancy test must be repeated every 3 months for at least 3 years; 3) commitment to use 2 effective forms of contraception (except the minipill) simultaneously for at least 1 month prior to initiation, during, and for at least 3 years following cessation of therapy unless reproductive status is posthysterectomy or postmenopausal; 4) monthly counseling by the prescriber during therapy and every 3 months for at least 3 years following therapy discontinuation about contraception and behaviors associated with an increased risk of pregnancy. Avoidance of St. John's wort during hormonal contraception and signed patient agreement/informed consent form, which includes warning to refrain from consumption of ethanol or ethanol-containing beverages during and for 2 months after treatment discontinuation and avoidance of pregnancy at start of treatment, during, and for at least 3 years after treatment discontinuation. The Pregnancy Prevention Actively Required During and After Treatment (Do Your PART) program requirements are available at www.soriatane.com/doyour-part-Program.html or 1-888-784-3335. Men and women must avoid donation of blood during and for at least 3 years following acitretin therapy. All patients must receive the medication guide each time acitretin is dispensed. Acitretin has also been associated with severe hepatotoxicity. Mild and reversible, severe, and fatal cases of hepatoxicity have been reported .
Serious side effects of Soriatane
Along with its needed effects, acitretin (the active ingredient contained in Soriatane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking acitretin:
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, tension, or tightness
- nausea (severe and continuing)
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- sleeplessness
- thinning of the skin with easy bruising
- tingling in the hands and feet
- tongue irritation
- trouble sleeping
- vomiting (severe and continuing)
Less common
- Abnormal sensation of burning or stinging
- blurred vision
- belching
- breast pain
- cracking, redness, skin irritation, or rash (including a rash that looks like psoriasis)
- eye pain
- general feeling of discomfort or illness
- heartburn
- increased hair growth on the forehead, back, arms, and legs
- indigestion
- infection, ulcers, unusual odor, or small red spots in the skin
- itching of the vagina or genital area
- loosening of the fingernails
- loss of eyebrows or eyelashes
- pain during sexual intercourse
- redness of the eyes
- redness or soreness around the fingernails
- redness or swelling of the eyelid
- sensitivity of the eyes to light
- sore mouth or tongue
- thick, white vaginal discharge with no odor or with a mild odor
- watery eyes
- white patches in the mouth or on the tongue
Rare
- Bleeding gums
- bleeding time increased
- chest pain
- coughing
- 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
- hoarseness
- 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
- sore on the edge of the eyelid (stye)
- stomach pain
- 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 discomfort
- confusion
- difficulty with speaking
- doing things to injure oneself
- 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
- slow speech
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arms or legs
- sweating
- thoughts of killing oneself
- unsteadiness or awkwardness
- vision changes
- weakness in the arms, hands, legs, or feet
Get emergency help immediately if any of the following symptoms of overdose occur while taking acitretin:
Symptoms of overdose
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- sensation of spinning
Other side effects of Soriatane
Some side effects of acitretin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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)
- scaling and peeling of the eyelids, fingertips, palms, and soles of feet
- sticky skin
- unusual thirst
Less common
- Constipation
- 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.
General
The most commonly reported side effects were hypervitaminosis A, skin peeling, alopecia, dry mucous membranes of mouth and nose, chelitis, increased triglycerides, and rhinitis.[Ref]
Hepatic
Very common (10% or more): Increased SGOT (up to 50%), increased SGPT (up to 50%), increased alkaline phosphatase (up to 25%), increased direct bilirubin (up to 25%), increased GGTP (up to 25%)
Common (1% to 10%): Increased globulin, increased total bilirubin, increased total protein, increased and decreased serum albumin
Uncommon (0.1% to 1%): Abnormal hepatic function, hepatitis, jaundice[Ref]
Metabolic
Very common (10% or more): Increased/decreased LDH (up to 50%), increased/decreased cholesterol (up to 50%), increased fasting blood sugar (up to 50%), decreased fasting blood sugar (up to 25%)
Common (1% to 10%): Increased appetite, anorexia, thirst
Uncommon (0.1% to 1%): Alcohol intolerance, weight increase[Ref]
Hypersensitivity
Postmarketing reports: Hypersensitivity, including angioedema and urticaria[Ref]
Cardiovascular
Common (1% to 10%): Hot flashes, flushing
Uncommon (0.1% to 1%): Chest pain, cyanosis, intermittent claudication, peripheral ischemia
Postmarketing reports: Acute myocardial infarction, thromboembolism, capillary leak syndrome, stroke[Ref]
Dermatologic
Very common (10% or more): Hypervitaminosis A (over 80%), skin peeling (up to 80%), alopecia (up to 75%), dry skin ( up to 50%), nail disorder (up to 50%), pruritus (up to 50%), scaling and thinning of healthy skin with increased sensitivity (up to 40%), erythema (up to 40%), sensation of "burning skin" (up to 40%), sensation of "sticky skin" (up to 40%), dermatitis (up to 40%), hair loss (up to 40%), inflammation of the nail wall (up to 40%), nail fragility (up to 40%), erythematous rash (up to 25%), paronychia (up to 25%), skin atrophy (up to 25%), skin fragility
Common (1% to 10%): Abnormal skin odor, abnormal hair texture, bullous eruption, cold/clammy skin, increased sweating, psoriasiform rash, purpura, pyogenic granuloma, rash, seborrhea, skin fissures, skin ulceration, sunburn, rhagades, blistering of the skin, change in pigmentation of the skin and hair, change in growth rate of hair, change in hair structure
Uncommon (0.1% to 1%): Acne, cyst, eczema, furunculosis, hyperkeratosis, hypertrichosis, hypoesthesia, otitis media, otitis externa, photosensitivity reactions, aggravated psoriasis, skin nodule, skin hypertrophy, skin disorder, skin irritation, sweat gland disorder, urticaria, verrucae
Rare (less than 0.1%): Retinoid dermatitis (occasionally provoking psoriatic lesion)
Postmarketing reports: Madarosis, exfoliative dermatitis/erythroderma[Ref]
Gastrointestinal
Very common (10% or more): Dry mucous membranes of mouth and nose (up to 80%), chelitis (more than 75%), high occult blood (up to 25%),
Common (1% to 10%): Abdominal pain, diarrhea, nausea, tongue disorder, gingival bleeding, gingivitis, increased saliva, stomatitis, ulcerative stomatitis, inflammation of oral mucosa and gingiva
Uncommon (0.1% to 1%): Constipation, dyspepsia, esophagitis, gastritis, gastroenteritis, glossitis, hemorrhoids, melena, tenesmus, tongue ulceration, altered saliva, anal disorder, gum hyperplasia, hemorrhage, pharyngitis, heartburn, inflammatory bowel disorders
Rare (less than 0.1%): Pancreatitis, icterus
Frequency not reported: Rectal hemorrhage[Ref]
Genitourinary
Very common (10% or more): WBC in urine (up to 50%), acetonuria, hematuria, RBC in urine
Common (1% to 10%): Glycosuria, proteinuria
Uncommon (0.1% to 1%): Atrophic vaginitis, abnormal urine, dysuria. penis disorder, leukorrhea, breast pain
Rare (less than 0.1%): Metrorrhagia
Postmarketing reports: Vulvo-vaginitis due to Candida albicans.[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (up to 25%), spinal hyperostosis
Common (1% to 10%): Arthritis, arthrosis, back pain, hypertonia, myalgia, osteodynia, peripheral joint hyperostosis (progression of existing lesions), demineralization and rarefaction of bone, cortical hyperostosis, periosteal calcification, premature epiphyseal closure, calcification of spinal ligaments resulting in spinal cord compression
Uncommon (0.1% to 1%): Muscle weakness, bone disorder, olecranon bursitis, tendonitis, scleroderma[Ref]
Nervous system
Very common (10% or more): Hyperesthesia (up to 25%), paresthesia (up to 25%)
Common (1% to 10%): Headache, taste perversion
Uncommon (0.1% to 1%): Dizziness, abnormal gait, migraine, neuritis, pseudotumor cerebri (intracranial hypertension), taste loss, dysgeusia, lassitude, disturbance of consciousness
Rare (less than 0.1%): Lightheadedness, visual disturbance
Postmarketing reports: Myopathy with peripheral neuropathy[Ref]
Ocular
Very common (10% or more): Conjunctivitis (up to 40%), xerophthalmia (up to 25%), dry eyes, eye irritation, intolerance of contact lenses
Common (1% to 10%): Abnormal/ blurred vision,
blepharitis, irritation, corneal epithelial abnormality, decreased night vision/night blindness, eye abnormality, eye pain, photophobia
Uncommon (0.1% to 1%): Abnormal lacrimation, chalazion, conjunctival hemorrhage, corneal ulceration, diplopia, ectropion, itchy eyes and lids,
papilledema, recurrent sties, subepithelial corneal lesions
Rare (less than 0.1%): Keratitis, abrasion and irregularities leading to corneal opacities[Ref]
Other
Very common (10% or more): Increased triglycerides (up to 75%), increased creatinine phosphokinase (up to 50%), feeling of cold (up to 40%), rigors (up to 25%), increased phosphorus (up to 25%), increased potassium (up to 25%), increased sodium (up to 25%), increased and decreased magnesium (up to 25%)
Common (1% to 10%): Edema, fatigue, pain, earache, tinnitus, decreased phosphorus, decreased potassium, decreased sodium, increased and decreased calcium, increased and decreased chloride, increased and decreased iron
Uncommon (0.1% to 1%): Fever, influenza-like symptoms, malaise, impaired healing, ceruminosis, deafness. peripheral edema, sensation of heat
Frequency not reported: Elevation in lactate dehydrogenase[Ref]
Respiratory
Very common (10% or more): Rhinitis (up 80%), epistaxis (up to 40%)
Common (1% to 10%): Sinusitis
Uncommon (0.1% to 1%): Coughing, increased sputum, laryngitis, dysphonia[Ref]
Endocrine
Rare (less than 0.1%): Gynecomastia[Ref]
Hematologic
Very common (10% or more): Increased reticulocytes (up to 50%), decreased hematocrit (up to 25%), decreased hemoglobin (up to 25%), decreased WBC (up to 25%), increased haptoglobin (up to 25%), increased neutrophils (up to 25%), increased WBC (up 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 RBC
Uncommon (0.1% to 1%): Increased bleeding time[Ref]
Immunologic
Uncommon (0.1% to 1%): Moniliasis, fungal infection, herpes simplex[Ref]
Oncologic
Frequency not reported: Pyogenic granuloma[Ref]
Psychiatric
Common (1% to 10%): Depression, insomnia, somnolence
Uncommon (0.1% to 1%): Anxiety, decreased libido, nervousness, abnormal thinking, emotional lability, aggressive feelings
Postmarketing reports: Suicidal thoughts[Ref]
Renal
Very common (10% or more): Increased uric acid (up to 25%)
Common (1% to 10%): Increased BUN, increased creatinine[Ref]
