Medical Editor: John P. Cunha, DO, FACOEP
Myorisan (isotretinoin capsules) is a retinoid indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Because of significant adverse effects associated with its use, Myorisan should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Myorisan is available in generic form. Common side effects of Myorisan include:
- skin peeling,
- dry eyes,
- dry mouth,
- dry skin,
- dry nose,
- hair loss,
- lip inflammation,
- lack of energy,
- skin sensitivity to sunlight,
- eye irritation,
- joint pain,
- skin infection, or
The recommended dosage range for Myorisan is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. Myorisan should be administered with a meal. Myorisan may interact with vitamin A, tetracyclines, micro-dosed progesterone preparations (“minipills” that do not contain an estrogen), norethindrone/ethinyl estradiol, St. John's wort, phenytoin, and systemic corticosteroids. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Myorisan. Myorisan is indicated only for those female patients who are not pregnant, because Myorisan can cause severe birth defects. Females must have 2 negative pregnancy tests before taking Myorisan. It is unknown of Myorisan passes in breast milk. Because of the potential for adverse effects, breastfeeding while using Myorisan is not recommended.
Our Myorisan (isotretinoin capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials And Postmarketing Surveillance
The adverse reactions listed below reflect the experience from investigational studies of Myorisan, and the postmarketing experience. The relationship of some of these events to Myorisan therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Myorisan are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, eg, of the lips, nasal passage, and eyes).
Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see WARNINGS).
Body as a Whole
inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease), hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms.
allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PATIENT INFORMATION). See PRECAUTIONS: Laboratory Tests for other hematological parameters.
skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density (see WARNINGS: Skeletal), musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia (see PATIENT INFORMATION), transient pain in the chest (see PATIENT INFORMATION), arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS: Laboratory Tests ).
Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
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 erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic /photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis; see PRECAUTIONS: Hypersensitivity), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PATIENT INFORMATION)
corneal opacities (see WARNINGS: Corneal Opacities ), decreased night vision which may persist (see WARNINGS: Decreased Night Vision), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances
Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PATIENT INFORMATION), elevated sedimentation rates, elevated platelet counts, thrombocytopenia
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
Read the entire FDA prescribing information for Myorisan (Isotretinoin Capsules)