"Oct. 25, 2012 -- Over-the-counter eyedrops and nose sprays contain powerful drugs that are poisonous in surprisingly small amounts if swallowed, the FDA warns.
Unwary parents often leave these products within easy reach of curious chi"...
(Generic versions may still be available.)
Florinef Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Florinef (fludrocortisone) Acetate is used to treat conditions in which the body does not produce enough of its own steroids, such as Addison's disease, and salt-losing adrenogenital syndrome. It is a steroid. The brand name Florinef is discontinued in the U.S. It is available in generic form. Common side effects include stomach upset, headache, and menstrual changes (e.g., delayed/irregular/absent periods).
Dosage of fludrocortisone depends on the severity of the disease and patient's response. To treat Addison's disease, the usual dose is 0.1 mg daily. The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg daily. Fludrocortisone may interact with aspirin, amphotericin B, diuretics (water pills), digoxin, phenytoin, rifampin, birth control pills or hormone replacement therapy, blood thinners, insulin or oral diabetes medications, steroids, or barbiturates. Tell your doctor all medications you use. During pregnancy, fludrocortisone should be used only when prescribed. Infants born to mothers who have used this medication may have low levels of corticosteroid hormone. Tell your doctor if you notice persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Florinef (fludrocortisone) Acetate 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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Florinef in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- problems with your vision;
- swelling, rapid weight gain, feeling short of breath;
- severe depression, unusual thoughts or behavior, seizure (convulsions);
- bloody or tarry stools, coughing up blood;
- pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- sleep problems (insomnia), mood changes;
- acne, dry skin, thinning skin, bruising or discoloration;
- slow wound healing;
- increased sweating;
- headache, dizziness, spinning sensation;
- nausea, stomach pain, bloating; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Florinef (Fludrocortisone) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Florinef Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: change in skin appearance (e.g., color changes, thinning, fatty areas), easy bleeding/bruising, dizziness, slow wound healing, signs of infection (e.g., fever, persistent sore throat, skin sores), bone/joint/muscle pain, stomach/abdominal pain, puffy face, swelling of the hands/feet, severe tiredness, increased thirst/urination, unusual weight gain, muscle weakness.
Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, eye problems (e.g., pain, redness, vision changes), severe/continuous headaches, fast/pounding/irregular heartbeat, mental/mood changes (e.g., agitation, depression, mood swings), seizure, vomit that looks like coffee grounds.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Florinef (Fludrocortisone)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Florinef FDA Prescribing Information: Side Effects
Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.
When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.
Musculoskeletal-muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures.
Dermatologic-impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions, and hives; reactions to skin tests may be suppressed.
Endocrine-menstrual irregularities; development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics.
Metabolic-hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.
Allergic Reactions-allergic skin rash, maculopapular rash, and urticaria.
Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.
Read the entire FDA prescribing information for Florinef (Fludrocortisone) »
Additional Florinef Information
Florinef - User Reviews
Florinef User Reviews
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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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