"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
Cortone Consumer (continued)
If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: black stools, bone/joint pain, easy bruising/bleeding, fast/pounding/irregular heartbeat, increased thirst/urination, mental/mood changes (e.g., depression, mood swings, agitation), muscle pain, persistent weight gain, puffy face, slow wound healing, seizures, signs of infection (e.g., fever, persistent sore throat), stomach/abdominal pain, swelling of the ankles/feet, thinning skin, trouble breathing, unusual hair growth, unusual skin growths, vision changes, vomit that looks like coffee grounds, weakness.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Cortone (cortisone acetate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking cortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, history of blood clots, brittle bones (osteoporosis), diabetes, eye diseases (e.g., cataracts, glaucoma, herpes infection of the eye), heart problems (e.g., congestive heart failure), high blood pressure, other infections (e.g., tuberculosis, herpes), kidney disease, liver problems (e.g., cirrhosis), mental/mood conditions (e.g., psychosis, anxiety, depression), low blood minerals (e.g., low potassium or calcium), stomach/intestinal problems (e.g., ulcer, ulcerative colitis, diverticulitis), thyroid problems.
This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any injuries or signs of infection (e.g., persistent sore throat/fever/cough, pain during urination, muscle aches) that occur during treatment.
Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, 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.
Do not have immunizations, vaccinations or skin tests unless specifically directed by your doctor. Live vaccines may cause serious complications (e.g., infection) if given while you are taking this medication. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.
If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this medication to decrease 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 medicine, exercise plan, or diet may need to be adjusted.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
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.
This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby. 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 immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Cortone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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