Uses

Fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. It is used along with other medications (such as hydrocortisone) to treat low glucocorticoid levels caused by disease of the adrenal gland (such as Addison's disease, adrenocortical insufficiency, salt-losing adrenogenital syndrome). Glucocorticoids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal. They are also needed to break down carbohydrates in your diet.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for a certain type of low blood pressure (chronic postural hypotension).

How To Use

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Your doctor will adjust your dose to the one that is best for you. The dosage is based on your medical condition and response to treatment.

In order to get the most benefit from this medication, follow the dosing schedule carefully, and take this medication exactly as prescribed. To help you remember, take it at the same time each day. If you are taking this medication on another schedule besides every day (such as only 3 days a week), it may help to mark your calendar with a reminder. Do not increase or decrease your dose, take this drug more often, or stop taking this medication without your doctor's approval. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Stomach upset, headache, and menstrual changes (such as delayed/irregular/absent periods) may occur. If any of these effects last or get worse, contact your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• change in skin appearance (such as color changes, thinning, fatty areas)
• easy bleeding/bruising
• dizziness
• slow wound healing
• signs of infection (such as sore throat that doesn't go away, fever, skin sores)
• bone/joint/muscle pain
• puffy face
• swelling of the hands/feet
• severe tiredness
• increased thirst/urination
• unusual weight gain
• muscle weakness
• eye problems (such as pain, redness, vision changes)
• severe/continuous headaches
• fast/pounding/irregular heartbeat
• mental/mood changes (such as agitation, depression, mood swings)
• seizure
• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking fludrocortisone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems
• blood clots
• brittle bones (osteoporosis)
• diabetes
• eye problems (such as cataracts, glaucoma, infection of the eye)
• heart problems (such as heart failure)
• high blood pressure
• infections (such as candidiasis, valley fever, herpes, tuberculosis)
• kidney disease
• liver disease (such as cirrhosis)
• mental/mood disorders (such as anxiety, depression, psychosis)
• low blood minerals (such as calcium, potassium)
• stomach/intestinal problems (such as diverticulitis, peptic ulcer disease, ulcerative colitis)
• seizures
• thyroid problems

Fludrocortisone makes your body hold on to salt (sodium) and get rid of other salts (such as calcium, potassium). Follow your doctor's advice on how much salt, potassium, and calcium should be in your diet.

This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

If you have a history of ulcers or take large doses of aspirin or other arthritis medicine, limit alcoholic beverages while taking this medication to lower the risk of stomach/intestinal bleeding.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and inform your doctor of the results. Your diabetic medication or diet may need to be adjusted.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

Older adults may be more sensitive to the side effects of this drug, especially water retention, bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aldesleukin
• digoxin
• drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen)
• hormones (such as androgens, birth control pills, estrogens)
• immunosuppressants (such as cyclosporine)
• mifepristone

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include high blood pressure, water retention, extreme weight gain, and muscle weakness.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, eye exams, sodium/potassium levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Different brands of this product have different storage needs. Check the product package for instructions on how to store your brand or ask the pharmacist. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).