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Elaprase (Idursulfase) - Side Effect Reports to FDA

 
 



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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