Idursulfase Side Effects

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

Idursulfase

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 Idursulfase:

Anxiety; general unwell feeling; headache; irritability; pain, swelling, or redness at the injection site; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue/purple discoloration of lips, nails, or skin; chest pain; fever; hoarseness; irregular heartbeat; joint pain; seizures; severe headache or dizziness; shortness of breath; vision changes; wheezing.

Side Effects by Body System

Hypersensitivity

Hypersensitivity side effects including anaphylactoid reactions have been observed in some patients during idursulfase infusions.

General

General side effects including pyrexia (63%), headache (59%), malaise (22%), and adverse events resulting from injury (13%) have been reported.

Immunologic

Immunologic side effects including anti-idursulfase IgG antibodies (51%) and abscess (16%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (31%), limb pain (28%), musculoskeletal dysfunction (16%), and chest wall musculoskeletal pain (16%) have been reported.

Dermatologic

Dermatologic side effects including pruritis (28%), urticaria (16%), superficial injury (13%), skin disorders (13%), and pruritic rash (13%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (25%) and atrial abnormality (13%) have been reported.

Ocular

Ocular side effects including visual disturbances (22%) have been reported.

Respiratory

Respiratory side effects including wheezing (19%) have been reported.

Nervous system

Nervous system side effects including anxiety and irritability (13%) have been reported.

Gastrointestinal

Gastrointestinal side effects including dyspepsia (13%) have been reported.

Local

Local side effects including infusion site edema (13%) have been reported.

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