Laronidase Side Effects

Please note - some side effects for Laronidase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Laronidase - for the Consumer

Laronidase

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 Laronidase:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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.

Local

Local side effects have included injection site reactions (18%) and injection site pain (9%).

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.

Hematologic

Hematologic side effects have included thrombocytopenia (9%).

Hepatic

Hepatic side effects have included bilirubinemia (9%).

Ocular

Ocular side effects have included corneal opacity (9%).

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions.

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