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 Florinef (Fludrocortisone). If you are concerned about side effects, discuss the risks and benefits of Florinef (Fludrocortisone) with your doctor.

The following side effects have been reported by at least 1% of people taking Florinef (Fludrocortisone). 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
• 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 Anaphylaxis (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 Florinef (Fludrocortisone).

Each white, scored tablet, imprinted with "RPC" and "059" contains Florinef (Fludrocortisone) acetate 0.1 mg.

Do not take Florinef (Fludrocortisone) if you:

• are allergic to Florinef (Fludrocortisone) or any ingredients of Florinef (Fludrocortisone)
• have a widespread fungal infection

There may be an interaction between Florinef (Fludrocortisone) and any of the following:

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 Florinef (Fludrocortisone). 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.

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 Florinef (Fludrocortisone).

Diabetes: Florinef (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 Florinef (Fludrocortisone), and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Electrolytes: Florinef (Fludrocortisone) may change the balance of electrolytes (e.g., sodium, potassium, and calcium) in your body while you are taking Florinef (Fludrocortisone). Your doctor will monitor your electrolyte levels with blood tests while you are taking Florinef (Fludrocortisone). 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 Florinef (Fludrocortisone) 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 Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), and whether any special monitoring is needed.

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

Heart disease: Florinef (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 Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), 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 Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), and whether any special monitoring is needed.

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

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): Florinef (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 Florinef (Fludrocortisone). If you have hypothyroidism, discuss with your doctor how Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), and whether any special monitoring is needed.

Mood changes: Corticosteroids such as Florinef (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 Florinef (Fludrocortisone) 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 Florinef (Fludrocortisone) contact your doctor as soon as possible.

If you experience mood changes while taking Florinef (Fludrocortisone), contact your doctor.

Myasthenia Gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Florinef (Fludrocortisone) can cause muscle wasting, decreasing muscle. If you have myasthenia gravis, discuss with your doctor how Florinef (Fludrocortisone) 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): Florinef (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 Florinef (Fludrocortisone) 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, and people at risk of Blood Clots you may be at risk of the condition worsening or the Florinef (Fludrocortisone) not acting as expected. Discuss with your doctor how Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), and whether any special monitoring is needed.

Stomach ulcer: Florinef (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 Florinef (Fludrocortisone) 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 Florinef (Fludrocortisone): Stopping Florinef (Fludrocortisone) suddenly can cause unwanted side effects. Do not stop taking Florinef (Fludrocortisone) without talking to your doctor. If you need to stop taking Florinef (Fludrocortisone), your doctor will tell you how to do so safely.

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

Tuberculosis: If you have had tuberculosis in the past, corticosteroids, including Florinef (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 Florinef (Fludrocortisone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Florinef (Fludrocortisone), and whether any special monitoring is needed.

Vaccines: You should not receive Smallpox vaccination while taking Florinef (Fludrocortisone). If you receive vaccines while taking Florinef (Fludrocortisone) you are more at risk for side effects from vaccines and lack of response to vaccines. Let your doctor know you are taking Florinef (Fludrocortisone) if you are going to receive a vaccine.

Pregnancy: Florinef (Fludrocortisone) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Florinef (Fludrocortisone), contact your doctor immediately.

Breast-feeding: It is not known if Florinef (Fludrocortisone) passes into breast milk. If you are a breast-feeding mother and are taking Florinef (Fludrocortisone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The active ingredient in Florinef (Fludrocortisone), Florinef (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 Florinef (Fludrocortisone) 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 Florinef (Fludrocortisone) by children.