Ceredase Side Effects

Generic Name: alglucerase

Please note - some side effects for Ceredase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ceredase - for the Consumer

Ceredase

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ceredase:

Chills; nausea; stomach discomfort.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; pain, burning, or swelling at the injection site; vomiting.

Ceredase Side Effects - for the Professional

Ceredase

Experience in over 1000 patients treated with Ceredase® has revealed a small number of adverse events. Some of these events were related to the route of administration including discomfort, pruritus, burning and swelling or sterile abscess at the site of venipuncture. The remaining experiences consisted of slight fever, chills, abdominal discomfort, nausea or vomiting. None of these events were judged to require medical intervention.

Symptoms suggestive of hypersensitivity have been noted in a limited number of patients. Onset of such symptoms has occurred during or shortly after infusions; these symptoms have included pruritus, flushing, urticaria/angioedema (a small number of patients have had upper airway involvement), chest discomfort, respiratory symptoms, nausea and abdominal cramping. Hypotension has been reported to occur during a few of these events.

Pretreatment with antihistamines and reduced rate of infusion has allowed continued use of Ceredase® in most patients. Additional adverse symptoms which have been reported include: fatigue, vasomotor irritability or hot flash, weakness, headache, light headedness, dysosmia, oral ulcerations, backache and transient peripheral edema, and diarrhea. Menstrual abnormalities and false positive pregnancy tests have previously been reported, but due to the introduction of manufacturing steps designed to reduce the level of hCG in Ceredase®, the likelihood of these occurrences is reduced.

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