Medical Editor: John P. Cunha, DO, FACOEP
Tell your doctor if you have serious side effects of Claravis including:
- increased brain pressure (severe headache, blurred vision, dizziness, nausea, vomiting, seizures, or stroke);
- a rash with a fever,
- blisters on legs, arms or face and/or
- sores in your mouth, throat, nose, eyes, or
- if your skin begins to peel;
- severe stomach, chest, or bowel pain;
- trouble swallowing or painful swallowing,
- new or worsening heartburn,
- rectal bleeding,
- yellowing of your skin or eyes,
- dark urine,
- back pain,
- joint pain,
- broken bones,
- hearing problems,
- vision problems, and
- blood sugar problems.
The recommended dosage range for Claravis is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. Claravis may interact with vitamin A, tetracycline antibiotics, hormonal contraceptives, St. John's Wort, phenytoin, and corticosteroids. Tell your doctor all medications and supplements you use. Claravis is not recommended for use during pregnancy; it may cause birth defects. Women must receive a negative pregnancy test before taking Claravis, and patients will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continuously one month before, during and one month after Claravis therapy, unless the patient commits to continuous abstinence. It is unknown if Claravis passes into breast milk. Because of the potential for unwanted effects on nursing infants, breastfeeding is not recommended while using Claravis and for one month after stopping treatment.
Our Claravis (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 Claravis, and the postmarketing experience. The relationship of some of these events to Claravis therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Claravis 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).
Suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors (see WARNINGS, Psychiatric Disorders), emotional instability. 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).
Vision: 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.
Read the entire FDA prescribing information for Claravis (Isotretinoin)