Accutane Side Effects
Generic name: isotretinoin
Note: This document contains side effect information about isotretinoin. Some of the dosage forms listed on this page may not apply to the brand name Accutane.
Some side effects of Accutane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to isotretinoin: oral capsule
Get emergency medical help if you have any of these signs of an allergic reaction while taking isotretinoin (the active ingredient contained in Accutane) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:
depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or weakness, especially on one side of the body;
blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
hearing problems, hearing loss, or ringing in your ears;
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
severe blistering, peeling, and red skin rash; or
joint stiffness, bone pain or fracture.
Less serious side effects of isotretinoin may include:
joint pain, back pain;
feeling dizzy, drowsy, or nervous;
dryness of the lips, mouth, nose, or skin; or
cracking or peeling skin, itching, rash, changes in your fingernails or toenails.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to isotretinoin: compounding powder, oral capsule
In general, many side effects associated with isotretinoin (the active ingredient contained in Accutane) 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 Accutane) 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 Accutane) 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 Accutane) 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 Accutane) 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.
More Accutane resources
- Accutane Consumer Overview
- Accutane Advanced Consumer (Micromedex) - Includes Dosage Information
- Accutane Prescribing Information (FDA)
- Accutane MedFacts Consumer Leaflet (Wolters Kluwer)
- Absorica Prescribing Information (FDA)
- Amnesteem Prescribing Information (FDA)
- Claravis Prescribing Information (FDA)
- Isotretinoin Monograph (AHFS DI)
- Myorisan Prescribing Information (FDA)
- Sotret Prescribing Information (FDA)
- Zenatane Prescribing Information (FDA)
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