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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.

For the Consumer

Applies to fludrocortisone: oral tablet

Along with its needed effects, fludrocortisone (the active ingredient contained in Florinef) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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

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

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

General

Most adverse reactions are caused by this drug's mineralocorticoid activity including retention of sodium and water, hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.[Ref]

Cardiovascular

Frequency not reported: Hypertension, cardiac enlargement, congestive heart failure, thrombophlebitis, syncope, cardiomegaly, syncope[Ref]

Gastrointestinal

Frequency not reported: Peptic ulcer, perforation, hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis, diarrhea[Ref]

Endocrine

Frequency not reported: Cushingoid state developed, growth suppression in children, secondary adrenocortical and pituitary unresponsiveness, carbohydrate tolerance decreased, manifestation of latent diabetes mellitus, insulin requirements increased, oral hypoglycemic agent requirements increased[Ref]

Metabolic

Frequency not reported: Hyperglycemia, negative nitrogen balance, potassium loss, hypokalemic alkalosis, sodium retention, fluid retention, appetite decreased[Ref]

Immunologic

Frequency not reported: Necrotizing angiitis, anaphylactoid reaction[Ref]

Musculoskeletal

Frequency not reported: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, spontaneous fractures[Ref]

Ocular

Frequency not reported: Posterior subcapsular cataract, intraocular pressure increased, glaucoma, exophthalmos[Ref]

Psychiatric

Frequency not reported: Mental disturbance, insomnia[Ref]

Dermatologic

Frequency not reported: Impaired wound healing, thin fragile skin, bruising, petechiae, ecchymoses, facial erythema, sweating increased, subcutaneous fat atrophy, purpura, striae, skin hyperpigmentation, nail hyperpigmentation, hirsutism, acneiform eruption, hives, reaction to skin tests suppressed, allergic skin rash, maculopapular rash, urticaria[Ref]

Genitourinary

Frequency not reported: Menstrual irregularity, glycosuria[Ref]

Nervous system

Frequency not reported: Convulsion, intracranial pressure increased, papilledema, vertigo, headache, seizure, epilepsy[Ref]

Other

Frequency not reported: Edema, infection aggravated, masking of infection[Ref]

References

1. "Product Information. Fludrocortisone Acetate (fludrocortisone)." Global Pharmaceutical Corporation, Philadelphia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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