- Clinician Information:
Zenatane Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zenatane (isotretinoin) is a retinoid used to treat severe recalcitrant nodular acne. This medication is available in generic form. Common side effects include dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair.
The recommended dosage range for Zenatane is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. Zenatane may interact with vitamin A, tetracyclines, progesterone, oral contraceptives, St. John's Wort, phenytoin, or corticosteroids. Tell your doctor all medications and supplements you use. Do not use Zenatane if you are pregnant or may become pregnant. Zenatane causes birth defects. Zenatane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating you understand the dangers of this medication and you agree to use birth control as required by the program. You must have a negative pregnancy test 30 days before you start taking this drug. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Zenatane, and again 30 days later. Consult your doctor for details on iPLEDGE. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Zenatane (isotretinoin) 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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zenatane FDA Prescribing Information: Side Effects
Clinical Trials and Post-marketing Surveillance
The adverse reactions listed below reflect the experience from investigational studies of Zenatane, and the post-marketing experience. The relationship of some of these events to Zenatane therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Zenatane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., 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 and ADVERSE REACTIONS).
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 xanthomas7,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 Zenatane (Isotretinoin Capsules) »
Additional Zenatane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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