Aldurazyme Side Effects

Generic Name: laronidase

Please note - some side effects for Aldurazyme 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 Aldurazyme - for the Consumer

Aldurazyme

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 Aldurazyme:

Flushing; headache; mild redness, stinging, or pain at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; cough; diarrhea; dizziness; fast or slow heartbeat; fever, chills, or sore throat; joint pain; nausea; numbness or tingling of the skin; rapid breathing; severe headache; stomach pain; unusual bruising or bleeding; unusual swelling; vision changes; vomiting.

Side Effects by Body System

Dermatologic

Dermatologic side effects have included rash, urticaria, pruritus, cold sweat, alopecia, and hyperhidrosis.

Facial edema has occurred in a few patients who had MPS I-related upper airway and pulmonary involvement

Respiratory

Respiratory side effects have included upper respiratory tract infection (32%), bronchospasm, dyspnea, and cough.

Cardiovascular

Cardiovascular side effects have included flushing (13%), increased blood pressure (10%), angioedema, and tachycardia.

Nervous system

Nervous system side effects have included headache (7%), paraesthesia, and dizziness.

Immunologic

Immunologic side effects have included development of IgG antibodies to laronidase, and abscesses (9%).

In the phase III double-blind study and the open-label extension study, almost all of the patients were observed to develop laronidase-specific IgG antibodies.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions.

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