Amnesteem Side Effects
Generic Name: isotretinoin
Note: This page contains information about the side effects of isotretinoin. Some of the dosage forms included on this document may not apply to the brand name Amnesteem.
Not all side effects for Amnesteem 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 isotretinoin: oral capsule, oral capsule liquid filled
Along with its needed effects, isotretinoin (the active ingredient contained in Amnesteem) 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 isotretinoin:More common
- Bone or joint pain
- burning, redness, itching, or other signs of eye inflammation
- difficulty moving
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- skin infection or rash
- Abdominal or stomach pain (severe)
- attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
- back pain
- bleeding or inflammation of the gums
- blurred vision or other changes in vision
- changes in behavior
- decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
- diarrhea (severe)
- headache (severe or continuing)
- mental depression
- nausea and vomiting
- pain or tenderness of the eyes
- pain, tenderness, or stiffness in the muscles (long-term treatment)
- rectal bleeding
- yellow eyes or skin
- Black, tarry stools
- bloody cough
- bloody or cloudy urine
- bone pain, tenderness, or aching
- burning or stinging of the skin
- chest pain
- cough or hoarseness
- dark-colored urine
- decrease in height
- difficulty breathing
- difficulty speaking
- difficulty swallowing
- discharge from the eyes
- double vision
- ear pain
- excessive tearing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever with or without chills
- fractures and/or delayed healing
- high blood pressure
- inability to move the arms, legs, or facial muscles
- inability to speak
- inflamed tissue from infection
- irregular yellow patch or lump on the skin
- joint pain, redness, stiffness, or swelling
- lack or slowing of normal growth in children
- loosening of the fingernails
- loss of appetite
- loss of bladder control
- loss or change in hearing
- muscle cramps, spasms, or weakness
- pain in the ribs, arms, or legs
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pains in the chest, groin, or legs, especially calves of the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- redness or soreness around the fingernails
- redness, soreness, or itching skin
- sensitivity of the eyes to sunlight
- shortness of breath
- skin rash
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stuffy or runny nose
- sudden loss of consciousness
- sudden loss of coordination
- sudden onset of severe acne on chest and trunk
- sudden onset of slurred speech
- swelling of the eyelids, face, lips, hands, lower legs, or feet
- swollen, painful or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unusual bleeding or bruising
- unusual weight gain or loss
- use of extreme physical or emotional force
- watery or bloody diarrhea
Some side effects of isotretinoin 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
- Crusting of the skin
- difficulty in wearing contact lenses (may continue after medicine is stopped)
- dryness of the eyes (may continue after treatment is stopped)
- dryness of the mouth or nose
- dryness or itching of the skin
- headache (mild)
- increased sensitivity of the skin to sunlight
- peeling of the skin on palms of the hands or soles of the feet
- stomach upset
- thinning of the hair (may continue after treatment is stopped)
- Abnormal menstruation
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
- changes in fingernails or toenails
- continuing ringing or buzzing, or other unexplained noise in the ears
- darkening of the skin
- hair abnormalities
- hair loss
- increased hair growth, especially on the face
- lightening of normal skin color
- lightening of treated areas of dark skin
- oily skin
- redness of the face
- severe sunburn
- skin rash, encrusted, scaly and oozing
- stomach burning
- trouble sleeping
- unable to sleep
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusually warm skin of the face
- voice changes
For Healthcare Professionals
Applies to isotretinoin: compounding powder, oral capsule
In general, many side effects associated with isotretinoin (the active ingredient contained in Amnesteem) are similar to those associated with very high doses of vitamin A (dryness of the skin and mucous membranes).
Dermatologic side effects have included cheilitis, severe mucosal drying, dry mouth, dry nose, dry skin, acne fulminans, flare of cystic acne, alopecia (persistent in some cases), epistaxis, eruptive xanthomas, erythema multiforme, skin fragility, hair abnormalities (including thinning of the hair), hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, palmoplantar desquamation, photoallergic/photosensitizing reactions, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, increased sunburn susceptibility, sweating, toxic epidermal necrolysis, urticaria, abnormal wound healing (delayed healing or exuberant granulation tissue with crusting), and pruritus. Keloid formation and pyoderma gangrenosum have been reported.
A few patients have experienced keloid formation on the face when isotretinoin was administered in conjunction with dermabrasion. Formation generally occurred between one and four months after dermabrasion. Keloid formation has occurred in patients who had been off isotretinoin for up to six months before dermabrasion was completed. Isotretinoin inhibits collagenase, which may result in accumulation of collagen and the formation of hypertrophic scars and keloids.
Metabolic side effects have included hypertriglyceridemia, altered blood sugar levels (including elevated fasting blood sugar), hyperuricemia, decreased serum high-density lipoprotein levels, and elevated lactate dehydrogenase, serum cholesterol, and alkaline phosphatase. An association between isotretinoin (the active ingredient contained in Amnesteem) and an unmasking of latent autoimmune diabetes has been reported in at least 1 case.
Ocular side effects have included corneal opacities, decreased night vision (persistent in some cases), cataracts, color vision disorder, conjunctivitis, blepharitis, keratitis, optic neuritis, eye irritation, photophobia, visual disturbances (including blurred vision), and dry eye syndrome. At least one case of transient myopia has been reported.
Dry eye syndrome, blepharitis, and conjunctivitis are due the drying effects of isotretinoin and the destabilization of tear-film caused by alterations in meibomian gland function and structure. They are commonly seen within the first four weeks of therapy and are reversible upon the discontinuation of medication. Bacterial conjunctivitis may also occur due to increased colonization of Staphylococcus aureus in the conjunctival sac.
A case reported that blurred vision and photophobia resolved quickly after stopping therapy, but decreased night vision persisted for several months.
Osteophytes generally form in the axial skeleton, especially the cervical spine, of patients receiving long-term therapy. Osteophytes also occur more frequently in patients receiving dosages greater than 2 mg/kg/day. One patient with a previous rhinoplasty experienced bilateral nasal bone osteophytes after five weeks of isotretinoin (the active ingredient contained in Amnesteem) therapy.
Myalgias and arthralgias that are mild and transient generally do not require discontinuation of therapy. Many patients with myalgias also have small hyperostotic lesions of the spine.
One patient, treated with isotretinoin for promyelocytic leukemia, developed myositis, fever, and pleural effusion that slowly resolved after isotretinoin was discontinued.
Causality for osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have not been established, although an effect cannot be ruled out. Longer term effects have not been studied.
Musculoskeletal side effects have included skeletal hyperostosis; calcification of tendons and ligaments; premature epiphyseal closure; decreased bone mineral density; musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia; transient chest pain; arthritis; tendonitis; other types of bone abnormalities; elevated creatine phosphokinase; and rare postmarketing reports of rhabdomyolysis. Muscular and joint pain, mild to moderate in severity, generally resolved following discontinuation of therapy. Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been reported. At least one case of myositis and several cases of osteophytes have been reported. Rarely, sacroiliitis has been reported.
A large retrospective population-based cohort study (n=7195) that analyzed data for isotretinoin (the active ingredient contained in Amnesteem) users provided no evidence that the use of isotretinoin was associated with an increased risk for depression, suicide, or other psychiatric disorders.
Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when isotretinoin is resumed.
Psychiatric side effects have included depression, nervousness, psychosis, aggression, violent behaviors, emotional instability, suicidal ideation, suicide attempts, and suicide.
Hematologic side effects have included anemia, increased erythrocyte sedimentation rate, leukopenia, thrombocytopenia, neutropenia, and rare reports of agranulocytosis. Laboratory side effects have included decreases in red blood cell parameters, decreases in white blood cell counts, and elevated platelet counts.
Nervous system side effects have included lethargy, headache, dizziness, drowsiness, insomnia, paresthesias, seizures, stroke, syncope, weakness, pseudotumor cerebri, hearing impairment, tinnitus, and Guillain-Barre syndrome. At least one case of cerebral ischemia has been reported.
Areflexic tetraparesis necessitating ventilatory support, preceded by symptoms of lethargy, epistaxis, cough, arthralgias, paresthesia of the feet, and influenza-like symptoms (Guillain-Barre syndrome), was reported in two male patients, a 31-year-old man and a 13-year-old boy, after oral isotretinoin therapy. Both patients received IV immunoglobulin (2 g/kg) and were discharge from hospital within three months. Neither patient was rechallenged with oral isotretinoin. First patient continued to use topical isotretinoin gel without any adverse effects.
A 30-year-old male experienced cerebral ischemia coincident with isotretinoin therapy. He had been given oral isotretinoin 45 mg per day for 3 months for treatment of severe acne. A cerebral computed tomography scan revealed hypodensity in the right middle cerebral territory corresponding to cerebral ischemia. No risk factors were determined. Isotretinoin was discontinued on admission and the adverse event resolved.
Hepatic side effects have included hepatitis and transient elevations in liver function tests (including AST, ALT, and GGTP).
Gastrointestinal side effects have included inflammatory bowel disease, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, and other nonspecific gastrointestinal symptoms. Taste disturbances (such as loss of taste), anal fissure, and rectal bleeding have been rarely reported.
Other side effects have included edema, fatigue, malaise, flushing, bruising, lymphadenopathy, and weight loss.
Cardiovascular side effects have included palpitation, tachycardia (including atrial tachycardia), vascular thrombotic disease, vasculitis (including Wegener's granulomatosis), and stroke.
A 22-year-old male with nodular acne experienced symptomatic heart palpitations of 1 week's duration coincident with isotretinoin therapy. He had undergone 2 complete courses of isotretinoin therapy without sequelae and was 3 weeks into his third course. A 12-lead electrocardiogram (ECG) showed atrial tachycardia at a rate of 127 beats per minute. The patient was discharged in stable condition. He was seen at follow-up visits 2 days, 1 week, and 3 months later and underwent serial ECGs each time that showed a gradual decline in heart rate and an eventual return to normal sinus rhythm.
Bronchoconstriction and exacerbation of preexisting asthma may be possibly due to the drying effects of isotretinoin (the active ingredient contained in Amnesteem) on the tracheobronchial tree. In a couple of cases, the condition resolved following discontinuation of therapy, but reoccurred when therapy was reinstituted.
Respiratory side effects have included bronchospasms (with or without a history of asthma), respiratory infection, and voice alteration. Bronchoconstriction and exacerbation of preexisting asthma have been reported in a few patients.
Hypersensitivity side effects have included allergic reactions, allergic vasculitis, systemic hypersensitivity, and anaphylactic reactions.
Renal side effects have included glomerulonephritis.
Genitourinary side effects have included abnormal menses, white cells in the urine, proteinuria, hematuria (microscopic or gross), and nonspecific urogenital findings.
Immunologic side effects have included a case report of isotretinoin-induced pemphigus.
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