Fludrocortisone Side Effects

Please note - some side effects for Fludrocortisone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Fludrocortisone - for the Consumer

Fludrocortisone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fludrocortisone:

Difficulty sleeping; dizziness or lightheadedness; headache; increased appetite; increased sweating; indigestion; nervousness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in menstrual periods; chest pain; eye pain or increased pressure in the eye; fever, chills, or sore throat; joint or bone pain; mood or mental changes (eg, depression); muscle pain or weakness; seizures; severe or persistent headache; severe or persistent nausea or vomiting; stomach pain or bloating; swelling of feet or legs; trouble sleeping; unusual weight gain or loss; vision changes; vomiting material that looks like coffee grounds.

Fludrocortisone Side Effects - for the Professional

Fludrocortisone

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.

Gastrointestinal:

Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

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.

Neurological:

Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances.

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.

Ophthalmic:

Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

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.

Side Effects by Body System

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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