Acitretin Side Effects

Not all side effects for acitretin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to acitretin: oral capsule

In addition to its needed effects, some unwanted effects may be caused by acitretin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • 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
Rare
  • 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 of the side effects that can occur with acitretin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Soriatane (acitretin)." Roche Laboratories, Nutley, NJ.

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