Florinef Acetate Side Effects

Generic name: fludrocortisone

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

For the Consumer

Applies to fludrocortisone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by fludrocortisone (the active ingredient contained in Florinef Acetate). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fludrocortisone:

Less common or rare:

• Abdominal pain
• agitation or combativeness
• anxiety
• back or rib pain
• blindness
• bloating
• bloody or black, sticky stools
• blurred vision
• burning in stomach
• changes in skin color
• chest pain or tightness
• chills
• confusion
• constipation
• convulsions
• cough
• coughing up blood
• darkened urine
• decrease in height
• decreased range of motion
• decreased urine output
• decreased vision
• depression
• difficulty swallowing
• dry mouth
• expressed fear of impending death
• eye pain
• eyeballs bulge out of eye sockets
• fainting or lightheadedness when getting up from a lying or sitting position
• fast or slow heartbeat
• fever
• flushed dry skin
• fractures in arms or legs without any injury
• fractures in the neck or back
• fruit-like breath odor
• hallucinations
• headache
• heartburn
• hives
• increased fat deposits on face, neck, and trunk
• increased hunger
• increased thirst
• increased urination
• indigestion
• irregular breathing or shortness of breath
• irregular heartbeat
• joint pain
• lack or slowing of normal growth in children
• walking with a limp
• loss of appetite
• loss of consciousness
• muscle cramps or pain
• nausea or vomiting
• nervousness
• pain, tenderness, or swelling of foot or leg
• pains in stomach or side, possibly radiating to the back
• patients taking oral medicines or insulin for diabetes may need to increase the amount they take
• pounding in the ears
• problems with wound healing
• redness and itching of skin
• redness of eyes
• redness of face
• severe or continuing dizziness
• severe weakness of arms and legs
• skin rash
• sweating
• swelling of face, fingers, feet, or lower legs
• swelling of nasal passages, face, or eyelids
• swollen neck veins
• tearing of eyes
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• weight gain
• wheezing
• yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with fludrocortisone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare:

• Acne, pimples
• bruising, large, flat, blue or purplish patches in the skin
• change in color of skin or nails
• increased sweating
• loss of muscle mass
• menstrual changes
• muscle weakness
• reddish purple lines on arms, face, legs, trunk, or groin
• sleeplessness, trouble sleeping, unable to sleep
• small, red, or purple spots on skin
• swelling of abdominal or stomach area, full or bloated feeling or pressure in the stomach
• thin, fragile skin
• unusual increase in hair growth

For Healthcare Professionals

Applies to fludrocortisone: compounding powder, oral tablet

Cardiovascular

Cardiovascular side effects have included hypertension, edema, cardiac enlargement, and congestive heart failure.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

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.^[Ref]

Ocular

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.^[Ref]

Psychiatric

Psychiatric side effects have included psychoses, personality or behavioral changes, and pseudotumor cerebri.^[Ref]

Dermatologic

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

Hematologic

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

Hepatic

Hepatic side effects have included reversible increases in serum transaminase and alkaline phosphatase concentrations.^[Ref]

Other

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

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.^[Ref]

Nervous system

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

Hypersensitivity

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

Not all side effects for Florinef Acetate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.