This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Naglazyme (Galsulfase) 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 (196)
Death (29)
Disability (3)
Reports by Reaction Type
Pneumonia (29),
Spinal Cord Compression (28),
Convulsion (17),
Death (7),
Bronchospasm (7),
Hydrocephalus (6),
Infusion Related Reaction (6),
Cervical Cord Compression (6),
Sleep Apnoea Syndrome (6),
Product Quality Issue (5),
Dyspnoea (5),
Asthma (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Naglazyme (Galsulfase). For a complete list or a specific selection of reports, please use the links above.
Possible Naglazyme side effects in 65 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: 65 year old male
Reactions: Cervical Spinal Stenosis, Lumbar Spinal Stenosis
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 8 year old male
Reported by a individual with unspecified qualification from Colombia on 2012-08-24
Patient: 8 year old male
Reactions: Jaundice, Hepatomegaly
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-08-22
Patient: female
Reactions: Bronchospasm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient: female, weighing 15.0 kg (33.0 pounds)
Reactions: Cervical Spinal Stenosis
Drug(s) suspected as cause:
Naglazyme
Other drugs received by patient: Albuterol; Flovent; Tylenol W / Codeine
Possible Naglazyme side effects in male
Reported by a individual with unspecified qualification from Brazil on 2012-08-17
Patient: male, weighing 22.0 kg (48.4 pounds)
Reactions: Visual Acuity Reduced, Carpal Tunnel Syndrome, Conductive Deafness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-08-17
Patient: female
Reactions: Dyspnoea, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a individual with unspecified qualification from Brazil on 2012-08-16
Patient: male, weighing 38.0 kg (83.6 pounds)
Reactions: Acute Respiratory Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a consumer/non-health professional from Chile on 2012-08-14
Patient: female
Reactions: Muscular Weakness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 18 year old female
Reported by a physician from Colombia on 2012-08-13
Patient: 18 year old female
Reactions: Dizziness, Intracranial Pressure Increased, Headache, Encephalocele
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 10 year old male
Reported by a consumer/non-health professional from Spain on 2012-08-10
Patient: 10 year old male
Reactions: Convulsion
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 18 year old female
Reported by a individual with unspecified qualification from Colombia on 2012-08-10
Patient: 18 year old female
Reactions: Dizziness, Headache, Intracranial Pressure Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a physician from Brazil on 2012-08-09
Patient: male
Reactions: Corneal Transplant
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a physician from Mexico on 2012-08-08
Patient: female, weighing 13.4 kg (29.5 pounds)
Reactions: Vith Nerve Paralysis
Drug(s) suspected as cause:
Naglazyme
Other drugs received by patient: Amoxacilin; Sterimar; Fluticasone Furoate
Possible Naglazyme side effects in male
Reported by a individual with unspecified qualification from United States on 2012-08-08
Patient: male
Reactions: Pneumonia, Pyrexia, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a physician from Japan on 2012-08-07
Patient: male
Reactions: Deafness, Influenza
Drug(s) suspected as cause:
Naglazyme
Start date: 2006-11-07
Naglazyme
Start date: 2009-10-06
Naglazyme
Indication: Mucopolysaccharidosis VI
Start date: 2008-04-01
End date: 2009-09-29
Other drugs received by patient: Adaptinol
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-08-06
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Procedural Complication
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-08-03
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Perforated Ulcer, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-03
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Procedural Complication
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 18 year old female
Reported by a individual with unspecified qualification from Colombia on 2012-08-01
Patient: 18 year old female
Reactions: Cardio-Respiratory Arrest, Respiratory Tract Oedema, Aeromona Infection, Bronchial Oedema, Bronchitis, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Colombia on 2012-07-31
Patient: female
Reactions: Convulsion
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a physician from United States on 2012-07-31
Patient: female, weighing 15.0 kg (33.0 pounds)
Reactions: Spinal Cord Compression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 18 year old female
Reported by a individual with unspecified qualification from Colombia on 2012-07-26
Patient: 18 year old female
Reactions: Respiratory Tract Oedema, Cardio-Respiratory Arrest, Bronchial Oedema, Aeromona Infection, Bronchitis, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a physician from Argentina on 2012-07-25
Patient: female
Reactions: Spinal Cord Compression, Urinary Incontinence, Encopresis
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-07-19
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Spinal Cord Compression
Drug(s) suspected as cause:
Naglazyme
Other drugs received by patient: Warfarin Sodium; EYE Drops; Cardilon; Acetaminophen; Hixizine
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-07-19
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Procedural Complication
Adverse event resulted in: death
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in female
Reported by a individual with unspecified qualification from Brazil on 2012-07-19
Patient: female, weighing 27.0 kg (59.4 pounds)
Reactions: Ulcer
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in 18 year old female
Reported by a physician from Colombia on 2012-07-19
Patient: 18 year old female
Reactions: Respiratory Tract Oedema, Respiratory Arrest
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a individual with unspecified qualification from United States on 2012-07-19
Patient: male
Reactions: Death, Choking, Infusion Related Reaction
Adverse event resulted in: death
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-13
Patient: male, weighing 13.0 kg (28.6 pounds)
Reactions: Lower Limb Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naglazyme
Possible Naglazyme side effects in male
Reported by a physician from Japan on 2012-07-13
Patient: male
Reactions: Deafness, Influenza
Drug(s) suspected as cause:
Naglazyme
Indication: Mucopolysaccharidosis VI
Start date: 2009-10-06
Naglazyme
Start date: 2006-11-07
Naglazyme
Start date: 2008-04-01
End date: 2009-09-29
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