"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 Consumer (continued)
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: mental/mood changes (e.g., depression), deep sleep, seizures, unusual tiredness, headache, hearing problems (e.g., buzzing/ringing in the ears), dizziness, eye/vision problems (e.g., blurred vision, loss of vision, eye pain), skin problems (e.g., thinning of the skin, stretch marks, purple bleeding patches on the elbows), bone problems (e.g., bone/joint/back pain, leg pain, broken bones).
Seek immediate medical attention if any of these rare but very serious side effects occur: black/bloody stools, stomach/abdominal pain, vomit that looks like coffee grounds.
Cysteamine can commonly cause a rash that may not be serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Seek immediate medical attention if you or your child develops any rash.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
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 Cystagon (cysteamine bitartrate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking cysteamine, tell your doctor or pharmacist if you are allergic to it; or to penicillamine; 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 or your child's medical history, especially of: liver disease, stomach/gut problems (e.g., bleeding, ulcers).
This drug may make you dizzy or drowsy. 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.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this medication passes into breast milk. It could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
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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