Fludrocortisone belongs to a class of medications called corticosteroids. It is used to treat conditions such as Addison's disease and adrenogenital syndrome that result in the adrenal gland not producing enough steroid hormones (e.g., cortisol). It works by reducing salt loss, increasing potassium loss, and increasing blood pressure.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

For Addison's disease, the usual dose is 0.1 mg daily. This dose may be increased or decreased depending on your response to this medication and side effects experienced. It is usually given along with cortisone or hydrocortisone.

For adrenogenital syndrome, the usual dose is 0.1 mg to 0.2 mg daily.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator at 2°C to 8°C and keep it out of the reach of children.

Each white, scored tablet, contains fludrocortisone acetate 0.1 mg.

Do not take this medication if you:

• are allergic to fludrocortisone or any ingredients of this medication
• have a widespread fungal infection

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne
• darkening of the skin
• difficulty sleeping
• growth suppression in children
• headache
• heartburn
• increased hair growth
• increased sweating
• menstrual changes
• muscle weakness
• nausea
• thin red lines on the skin
• thinning skin

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• cuts that do not heal properly
• high blood pressure
• sensation of spinning
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of gastrointestinal bleeding (e.g., black, tarry stools; vomiting of material that looks like coffee grounds; rectal bleeding)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse; chest pain; difficulty breathing; swollen feet or ankles)
• signs of reduced ability for blood to clot (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding)
• symptoms of bone loss (e.g., back pain, bone pain, broken bones)
• symptoms of high blood sugar (e.g., increased thirst, increased urination, weight loss)
• symptoms of low potassium levels (e.g., muscle cramps, fatigue, racing heartbeat)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of a severe allergic reaction (such as hives; difficulty breathing; or swelling of the face, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: Fludrocortisone may cause a loss of control of diabetes by increasing blood glucose (sugar). If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Electrolytes: Fludrocortisone may change the balance of electrolytes (e.g., sodium, potassium, and calcium) in your body while you are taking this medication. Your doctor will monitor your electrolyte levels with blood tests while you are taking this medication. Your doctor may ask you to restrict your salt intake or take potassium supplements to correct electrolyte imbalances.

If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible.

Eye problems: When this medication is used for long periods of time, it may cause eye problems such as cataracts and glaucoma. Report any vision changes or eye discomfort to your doctor immediately.

If you have herpes simplex infections of the eye, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fluid retention (edema): This medication can cause fluid retention which can lead to high blood pressure and changes in heart function. If you develop high blood pressure, swelling of the feet or ankles, or sudden weight gain while taking this medication, contact your doctor.

Heart disease: Fludrocortisone may cause an elevation of blood pressure, salt and water retention, and increased excretion of potassium.

If you are at risk of developing high blood pressure, or you have a history of high blood pressure, or heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: Corticosteroids can reduce your body's ability to fight infections and may hide signs of infection that is developing. If you develop symptoms of an infection (e.g., sore throat, cough, fever, chills, difficult or painful urination), contact your doctor immediately.

Kidney problems: If you have kidney problems or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver disease: People with liver cirrhosis may be more sensitive to the effects of this medication. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low thyroid (hypothyroidism): Fludrocortisone may not be removed from the body at the expected rate if you have an underactive thyroid. As a result, you may be more sensitive to the effects of this medication. If you have hypothyroidism, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mood changes: Corticosteroids such as fludrocortisone may make mood disorders worse and worsen mood changes such as elevated mood, difficulty sleeping, mood swings, personality changes, and depression.

If you have a history of mental changes, such as depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

If you experience mood changes while taking this medication, contact your doctor.

Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Fludrocortisone can cause muscle wasting, decreasing muscle. If you have myasthenia gravis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Osteoporosis (bone disease): Fludrocortisone causes the body to lose calcium and may cause osteoporosis to develop or worsen. If you have osteoporosis or are at risk of developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other medical conditions: If you have ulcerative colitis, diverticulitis, Cushing's syndrome, diabetes, seizures, cancer that has spread to other parts of the body, or are at risk of blood clots, you may be at risk of the condition worsening or the fludrocortisone not acting as expected. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach ulcer: Fludrocortisone may cause stomach ulcers to worsen or develop. If you have stomach problems or a history of stomach problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping this medication: Stopping this medication suddenly can cause unwanted side effects. Do not stop taking this medication without talking to your doctor. If you need to stop taking this medication, your doctor will tell you how to do so safely.

Stressful situations: When your body is under significant stress (e.g., such as during surgery, trauma, or severe illness), you may require additional corticosteroid therapy while you are taking this medication and for up to one year after stopping this medication.

Tuberculosis: If you have had tuberculosis in the past, corticosteroids, including fludrocortisone, may cause the infection to return. If you experience signs of infection such as sore throat, fever, sneezing, or coughing, contact your doctor as soon as possible. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vaccines: You should not receive smallpox vaccination while taking this medication. If you receive vaccines while taking this medication, you are more at risk for side effects from vaccines and lack of response to vaccines. Let your doctor know you are taking this medication if you are going to receive a vaccine.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if fludrocortisone passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The active ingredient in this medication, fludrocortisone, belongs to the family of medications known as corticosteroids. Children may be more likely to experience the side effects encountered by using this class of medication for long periods of time (e.g., slowing down of growth, delayed weight gain). The use of this medication by children should be limited to the smallest dose that will be effective. Discuss with your doctor the risks and benefits of the use of this medication by children.

There may be an interaction between fludrocortisone and any of the following:

• acetylsalicylic acid (ASA)
• aldesleukin
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• anticancer medications (e.g., cladribine)
• apalutamide
• baricitinib
• BCG
• calcitriol
• carbamazepine
• cholestyramine
• colesevelam
• deferasirox
• denosumab
• desmopressin
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• donepezil
• diuretics (water pills; e.g. furosemide, hydrochlorothiazide, metolazone)
• echinacea
• enzalutamide
• estrogens
• fingolimod
• galantamine
• isoniazid
• leflunomide
• lumacaftor and ivacaftor
• mifepristone
• mitotane
• natalizumab
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
• ocrelizumab
• phenobarbital
• phenytoin
• pimecrolimus
• ponesimod
• primidone
• quinolone antibiotics (e.g., ciprofloxacin, ofloxacin)
• rifampin
• rivastigmine
• siponimod
• somatropin
• tacrolimus
• testosterone
• tofacitinib
• upadacitinib
• vaccines
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.