"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
Cystagon Patient Information Including Side Effects
Brand Names: Cystagon
Generic Name: cysteamine (Pronunciation: sis TEE a meen)
- What is cysteamine (Cystagon)?
- What are the possible side effects of cysteamine (Cystagon)?
- What is the most important information I should know about cysteamine (Cystagon)?
- What should I discuss with my health care provider before using cysteamine (Cystagon)?
- How should I use cysteamine (Cystagon)?
- What happens if I miss a dose (Cystagon)?
- What happens if I overdose (Cystagon)?
- What should I avoid while taking cysteamine (Cystagon)?
- What other drugs will affect cysteamine (Cystagon)?
- Where can I get more information?
What is cysteamine (Cystagon)?
Cysteamine is used to treat a condition called nephropathic cystinosis (NEF-roe-PATH-ik SIS-tin-OH-sis). It works by reducing the amount of cystine in the kidneys.
Nephropathic cystinosis is a rare genetic condition. Children with this condition develop a build-up of cystine in the kidneys, which can lead to kidney failure and other medical problems.
Cysteamine may also be used for other purposes not listed in this medication guide.
What are the possible side effects of cysteamine (Cystagon)?
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using cysteamine and call your child's doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- the first sign of any skin rash, no matter how mild;
- unusual bruising or streaks on the skin;
- bone or joint problems;
- weakness or fainting, black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- extreme drowsiness, loss of balance or coordination, seizure (convulsions);
- confusion, hallucinations, bad dreams, or changes in mood or behavior;
- urinating less than usual or not at all; or
- headache, ringing in the ears, dizziness, nausea, vision problems, pain behind the eyes.
Less serious side effects may include:
- nausea, vomiting, diarrhea, stomach pain;
- loss of appetite;
- fever, chills, body aches, flu symptoms; or
- mild dizziness, nervous feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Cystagon (cysteamine bitartrate) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about cysteamine (Cystagon)?
Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).
Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has skin or bone problems (including fractures), liver disease, epilepsy or other seizure disorder, a history of depression or nervous system disorder, or a history or stomach ulcer or bleeding.
There may be other medicines that can interact with cysteamine. Tell your child's doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child's doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.
Additional Cystagon 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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