This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Elaprase (Idursulfase) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (90)
Death (18)
Life Threatening Events (2)
Reports by Reaction Type
Infusion Related Reaction (35),
Urticaria (10),
Anaphylactoid Reaction (9),
Dyspnoea (9),
Rash (9),
Pyrexia (6),
Death (6),
Overdose (5),
Drug Effect Decreased (5),
Pneumonia (5),
LIP Swelling (4),
Increased Upper Airway Secretion (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Elaprase (Idursulfase). For a complete list or a specific selection of reports, please use the links above.
Possible Elaprase side effects in 10 year old male
Reported by a consumer/non-health professional from Brazil on 2012-08-23
Patient: 10 year old male, weighing 30.9 kg (68.1 pounds)
Reactions: Body Temperature Increased, Nausea, Oedema, Obstructive Airways Disorder, Rash, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from Italy on 2012-08-23
Patient: male
Reactions: Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-14
Patient: male, weighing 20.4 kg (44.9 pounds)
Reactions: Chills, Pyrexia, Headache, Tremor, Feeling Cold, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Dosage: 2 df, 1x/week
Indication: Mucopolysaccharidosis II
Start date: 2012-05-30
Elaprase
Dosage: unk, unknown
Start date: 2012-08-01
Elaprase
Dosage: 2 df, 1x/week
Start date: 2012-06-06
Elaprase
Dosage: 2 df, 1x/week
Start date: 2010-05-30
Elaprase
Dosage: 0.5 mg/kg, unknown
Start date: 2012-03-29
Elaprase
Dosage: unk, unknown
Start date: 2012-06-27
Other drugs received by patient: Selenium
Possible Elaprase side effects in 10 year old male
Reported by a pharmacist from United States on 2012-08-03
Patient: 10 year old male, weighing 40.8 kg (89.8 pounds)
Reactions: Restlessness, Urine Odour Abnormal, Pyrexia, Lethargy, Crying, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-07-31
Patient: male
Reactions: Splenomegaly
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from Brazil on 2012-07-31
Patient: male
Reactions: Splenomegaly
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male
Reactions: Pneumonia, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from United States on 2012-07-25
Patient: male
Reactions: Flushing, Surgery, Rash, Infusion Related Reaction, Infusion Site Swelling, Infusion Site Erythema
Drug(s) suspected as cause:
Coumadin
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Elaprase
Dosage: 24 mg, 1x/week
Indication: Mucopolysaccharidosis II
Start date: 2008-03-04
Other drugs received by patient: Benadryl
Possible Elaprase side effects in male
Reported by a pharmacist from United Kingdom on 2012-07-23
Patient: male
Reactions: Catheter Site Haemorrhage, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: male
Reactions: Dyspnoea, Heart Rate Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from United Kingdom on 2012-07-16
Patient: male
Reactions: Cytogenetic Abnormality, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from United Kingdom on 2012-07-13
Patient: male
Reactions: Cytogenetic Abnormality, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: male, weighing 38.8 kg (85.4 pounds)
Reactions: Dehydration, Oral Herpes
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-03
Patient: male, weighing 44.0 kg (96.8 pounds)
Reactions: Functional Gastrointestinal Disorder, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: male
Reactions: Pneumonia
Adverse event resulted in: death
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male
Reactions: Adverse Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: male, weighing 28.0 kg (61.6 pounds)
Reactions: Hypersensitivity, Increased Upper Airway Secretion, Urticaria, Obstructive Airways Disorder, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Other drugs received by patient: Gabapentin; Heparin; Motilium / 00498201 /; Clonazepam
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: male
Reactions: Cardiac Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from Italy on 2012-06-04
Patient: male
Reactions: Cardio-Respiratory Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from United States on 2012-06-01
Patient: male
Reactions: Dyspnoea, Heart Rate Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a pharmacist from United States on 2012-05-25
Patient: male, weighing 34.0 kg (74.8 pounds)
Reactions: Dyspnoea, Chills, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from France on 2012-05-23
Patient: male, weighing 30.0 kg (66.0 pounds)
Reactions: Drug Effect Decreased, Overdose, Anaphylactoid Reaction, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Dosage: 30 mg, 1x/week
Indication: Mucopolysaccharidosis II
Start date: 2010-01-01
End date: 2012-03-09
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2007-01-01
End date: 2010-01-01
Possible Elaprase side effects in 13 year old male
Reported by a physician from Brazil on 2012-05-18
Patient: 13 year old male
Reactions: Cardiopulmonary Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from Brazil on 2012-05-18
Patient: male
Reactions: Eyelid Oedema, Nausea, Urticaria, Rash, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2012-02-27
End date: 2012-02-27
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Indication: Mucopolysaccharidosis II
End date: 2012-01-16
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2012-02-06
End date: 2012-02-06
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2012-02-13
End date: 2012-02-13
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2012-02-20
End date: 2012-02-20
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient: male
Reactions: Hand-Foot-and-Mouth Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in 3 year old male
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-05-07
Patient: 3 year old male
Reactions: Therapeutic Response Delayed, Respiratory Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-05-02
Patient: male, weighing 8.5 kg (18.7 pounds)
Reactions: Off Label Use, Cardiac Failure, Pyrexia, Bronchiolitis, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Other drugs received by patient: Captopril; Spironolactone; Coreg; Furosemide; Comicorte
Possible Elaprase side effects in 3 year old male
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-04-27
Patient: 3 year old male
Reactions: Therapeutic Response Delayed, Respiratory Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Elaprase
Possible Elaprase side effects in male
Reported by a physician from France on 2012-04-27
Patient: male, weighing 30.0 kg (66.0 pounds)
Reactions: Overdose, Drug Effect Decreased, Anaphylactoid Reaction, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Dosage: 30 mg, 1x/week
Indication: Mucopolysaccharidosis II
Start date: 2010-01-01
End date: 2012-03-09
Elaprase
Dosage: 0.5 mg/kg, 1x/week
Start date: 2007-01-01
End date: 2010-01-01
Possible Elaprase side effects in male
Reported by a consumer/non-health professional from Sweden on 2012-04-19
Patient: male, weighing 21.0 kg (46.2 pounds)
Reactions: Dyspnoea, Throat Irritation, Urticaria, Rash, Infusion Related Reaction
Drug(s) suspected as cause:
Elaprase
Other drugs received by patient: Ebastine; Solu-Cortef; Antihistamines
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