Florinef Side Effects

Generic name: fludrocortisone

Note: This document contains side effect information about fludrocortisone. Some of the dosage forms listed on this page may not apply to the brand name Florinef.

Some side effects of Florinef may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fludrocortisone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fludrocortisone (the active ingredient contained in Florinef) 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 of fludrocortisone 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.

For Healthcare Professionals

Applies to fludrocortisone: compounding powder, oral tablet

Cardiovascular

Cardiovascular side effects have included hypertension, edema, cardiac enlargement, and congestive heart failure.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis, ulcerative esophagitis, gastrointestinal perforation and hemorrhage also have been reported.

Endocrine

Corticosteroids may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Diabetes mellitus requiring diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression can persist for twelve months or longer following long-term corticosteroid therapy.

Endocrine side effects have included decreased glucose tolerance and hyperglycemia resulting in diabetes-like symptoms and/or increased requirements of hypoglycemic agents in diabetics. Hypothalamic-pituitary-adrenal activity has been suppressed for 12 months or longer following long-term fludrocortisone administration. Cushingoid appearance has been a common occurrence with chronic therapy and hirsutism or virilism, impotence, and menstrual irregularities have occurred.

Metabolic

Metabolic side effects have included significant sodium retention, hypokalemia and hypocalcemia. Other side effects have included hyperglycemia, glycosuria, and negative nitrogen balance due to increased protein catabolism.

Immunologic

Immunologic side effects have included impairment in cell-mediated immunity and increased susceptibility to bacterial, viral, fungal, and parasitic infections. Immune responses to skin tests have been suppressed.

Musculoskeletal

Corticosteroid myopathy presenting as weakness and wasting of the proximal limb and girdle muscles has occurred. Symptoms resolved following cessation of therapy.

Corticosteroids inhibit intestinal absorption and increase urinary excretion of calcium leading to bone resorption and bone loss.

Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression fractures, tendon rupture (particularly the Achilles tendon), pathologic fracture of long bones, and aseptic necrosis of bone. Aseptic necrosis has been reported to most often affect the femoral head.

Ocular

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.

Psychiatric

Psychiatric side effects have included psychoses, personality or behavioral changes, and pseudotumor cerebri.

Dermatologic

Dermatologic side effects have included bruising, ecchymosis, petechiae, striae, delayed/impaired wound healing, acne, hirsutism, and hyperpigmentation of the skin and nails.

Hematologic

Hematologic side effects have included platelet alterations resulting in thrombolic events, thrombocytopenia, and lymphopenia.

Hepatic

Hepatic side effects have included reversible increases in serum transaminase and alkaline phosphatase concentrations.

Other

Other side effects have included a glucocorticoid withdrawal syndrome (not related to adrenal insufficiency) following abrupt discontinuation of corticosteroid.

Pseudorheumatism, or glucocorticoid-withdrawal syndrome not related to adrenal insufficiency has occurred on withdrawal of corticosteroids. Patients have experienced anorexia, nausea, vomiting, lethargy, headache, fever, arthralgias, myalgias, and postural hypotension. Symptoms resolved when corticosteroid therapy was reinstated.

Nervous system

Neurologic system side effects have included convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri), vertigo, and headache.

Hypersensitivity

Hypersensitivity side effects have included allergic skin rash, maculopapular rash, and urticaria. Anaphylactoid reactions have occurred with corticosteroid use.

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