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- Clinician Information:
Miradon Side Effects Center
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.
Miradon FDA Prescribing Information: Side Effects
Multisystem adverse reactions have been reported, and some may be serious enough to warrant hospital admission. In general, they may be divided into 2 categories: those which involve abnormal bleeding and other effects which do not. Hemorrhage and/or necrosis are among the hazards of treatment with any anticoagulant and are the main serious complications of therapy. For additional discussion of possible hemorrhagic complications following oral anticoagulant therapy see WARNINGS. Although most of the adverse reactions for oral anticoagulant drugs have been reported for warfarin, dicumarol, and phenindione, all the drugs within this class have similar pharmacologic and clinical properties, and require the same degree of caution in monitoring adverse reactions regardless of the drug administered.
Some indanediones (phenindione)have been associated with undesirable reactions which have not been reported with the coumarins and are not counterbalanced by advantages, thus perhaps favoring the use of the coumarin-type anticoagulants. Changing from one chemical type of oral anticoagulant to the other may eliminate an adverse reaction, such as rash or diarrhea. Dermatitis is the only untoward reaction consistently associated with anisindione therapy.
Adverse reactions reported following therapy with either coumarin or indanedione anticoagulants include:nausea, diarrhea, pyrexia, dermatitis or exfoliative dermatitis, urticaria, alopecia, and sore mouth or mouth ulcers.
Side effects which have additionally been reported for coumarin derivatives include:vomit-ing, abdominal cramps, anorexia, priapism, ery-thema and necrosis of the skin and other tissues, manifesting as purple toes and cutaneous gangrene. There is no reason to expect that some or all of these adverse reactions might not occur in patients receiving anisindione.
Additional side effects attributed to the indane-dione anticoagulants include: headache, sore throat, blurred vision, paralysis of accommodation, steatorrhea, hepatitis, jaundice, liver damage, renal tubular necrosis, albuminuria, anuria, myeloid immaturity, agranulocytosis, leukocyte agglutinins, red cell aplasia, atypical mononuclear cells, leukopenia, leukocytosis, anemia, thrombo-cytopenia, and eosinophilia.
Read the entire FDA prescribing information for Miradon (Anisindione) »
Additional Miradon Information
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