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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 Myorisan.
Common side effects of Myorisan include: cheilitis, epistaxis, hypertriglyceridemia, pruritus, xerosis cutis, decreased hdl cholesterol, increased liver enzymes, increased serum triglycerides, musculoskeletal signs and symptoms, dry nose, xeroderma, and xerostomia. Other side effects include: increased serum cholesterol. See below for a comprehensive list of adverse effects.
Applies to isotretinoin: oral capsule, oral capsule liquid filled
Oral route (Capsule, Liquid Filled)
Pregnancy Category XIsotretinoin must not be used by patients who are or may become pregnant.There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time.Potentially any fetus exposed during pregnancy can be affected.There are no accurate means of determining whether an exposed fetus has been affected.Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.If pregnancy does occur during treatment of a patient who is taking isotretinoin, isotretinoin must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.Special Prescribing Requirements:Because of the risk of teratogenicity and to minimize fetal exposure, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE®. Under the isotretinoin REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program.
Along with its needed effects, isotretinoin (the active ingredient contained in Myorisan) 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:
Incidence not known
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:
Incidence not known
Applies to isotretinoin: compounding powder, oral capsule
The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).
Very common (10% or more): Cheilitis/dry lips (up to 90%)
Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease
Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums
Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)
Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis
Rare (0.01% to 0.1%): Agranulocytosis
Very rare (less than 0.01%): Lymphadenopathy
Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts
Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)
Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein
Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia
Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein
Postmarketing reports: Increased fasting blood glucose levels
Bronchospasm occurred in patients receiving treatment, especially in those with asthma.
Very common (10% or more): Epistaxis (Up to 30%)
Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis
Very rare (less than 0.01%): Bronchospasm, dry throat
Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration
In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks
Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma
Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia
Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles
Postmarketing reports: Bruising, seborrhea
Papilledema occurred as a sign of benign intracranial hypertension.
Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation
Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum
Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation
Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels
Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons
Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain
Back pain occurred more frequently in children and adolescent patients.
Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.
Common (1% to 10%): Proteinuria, microscopic or gross hematuria
Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine
Common (1% to 10%): Headache
Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness
Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope
Common (1% to 10%): Transient and reversible increased transaminase levels
Very rare (less than 0.01%): Hepatitis
Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin
Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.
Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations
Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide
Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders
Postmarketing reports: Auditory hallucinations
Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
Frequency not reported: Allergic reactions
Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise
Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)
Postmarketing reports: Infection
Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing
Very rare (less than 0.01%): Glomerulonephritis
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