Clinical Trials and PostmarketingSurveillance
The adverse reactions listed below reflect the experiencefrom investigational studies of Accutane, and the postmarketing experience.The relationship of some of these events to Accutane therapy is unknown.Many of the side effects and adverse reactions seen in patients receivingAccutane are similar to those described in patients taking very highdoses of vitamin A (dryness of the skin and mucous membranes, eg,of the lips, nasal passage, and eyes).
Cheilitis and hypertriglyceridemia are usually doserelated. Most adverse reactions reported in clinical trials were reversiblewhen therapy was discontinued; however, some persisted after cessationof therapy (see WARNINGS and ADVERSE REACTIONS).
Body as a Whole
allergic reactions, including vasculitis, systemichypersensitivity (see PRECAUTIONS: Hypersensitivity), edema, fatigue, lymphadenopathy, weight loss
palpitation, tachycardia, vascular thrombotic disease,stroke
hypertriglyceridemia (see WARNINGS: Lipids),alterations in blood sugar levels (see PRECAUTIONS: Laboratory Tests)
inflammatory bowel disease (see WARNINGS: InflammatoryBowel Disease), hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids), bleeding andinflammation of the gums, colitis, esophagitis/esophageal ulceration,ileitis, nausea, other nonspecific gastrointestinal symptoms
allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia, thrombocytopenia, neutropenia, rare reportsof agranulocytosis (see PRECAUTIONS: Information for Patients). See PRECAUTIONS: Laboratory Tests for other hematological parameters.
skeletal hyperostosis, calcification of tendons andligaments, premature epiphyseal closure, decreases in bone mineraldensity (see WARNINGS: Skeletal), musculoskeletal symptoms(sometimes severe) including back pain, myalgia, and arthralgia (see PRECAUTIONS: Informationfor Patients), transient pain in the chest (see PRECAUTIONS: Informationfor Patients), arthritis, tendonitis, other typesof bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis(see PRECAUTIONS: Laboratory Tests).
pseudotumor cerebri (see WARNINGS: Pseudotumor Cerebri), dizziness, drowsiness, headache, insomnia, lethargy,malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness
suicidal ideation, suicide attempts, suicide, depression,psychosis, aggression, violent behaviors (see WARNINGS: Psychiatric Disorders), emotional instability
Of thepatients reporting depression, some reported that the depression subsidedwith discontinuation of therapy and recurred with reinstitution oftherapy.
bronchospasms (with or without a history of asthma),respiratory infection, voice alteration
Skin and Appendages
acne fulminans, alopecia (which in some cases persists),bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis,eruptive xanthomas,[ 7 ] flushing,fragility of skin, hair abnormalities, hirsutism, hyperpigmentationand hypopigmentation, infections (including disseminated herpes simplex),nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizingreactions, pruritus, pyogenic granuloma, rash (including facial erythema,seborrhea, and eczema), sunburn susceptibility increased, sweating,urticaria, vasculitis (including Wegener's granulomatosis; see PRECAUTIONS: Hypersensitivity), abnormal wound healing (delayed healing or exuberantgranulation tissue with crusting; see PRECAUTIONS: Information for Patients)
hearing impairment (see WARNINGS: Hearing Impairment), tinnitus.
corneal opacities (see WARNINGS: Corneal Opacities), decreased night vision which may persist (see WARNINGS: DecreasedNight Vision), cataracts, color vision disorder,conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis,photophobia, visual disturbances
glomerulonephritis (see PRECAUTIONS: Hypersensitivity), nonspecific urogenital findings (see PRECAUTIONS: LaboratoryTests for other urological parameters)
Elevation of plasma triglycerides (see WARNINGS: Lipids), decrease in serum high-density lipoprotein (HDL) levels,elevations of serum cholesterol during treatment
Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH(see WARNINGS:Hepatotoxicity)
Elevationof fasting blood sugar, elevations of CPK (see PRECAUTIONS: Laboratory Tests), hyperuricemia
Decreases in redblood cell parameters, decreases in white blood cell counts (includingsevere neutropenia and rare reports of agranulocytosis; see PRECAUTIONS: Informationfor Patients), elevated sedimentation rates,elevated platelet counts, thrombocytopenia
Whitecells in the urine, proteinuria, microscopic or gross hematuria