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Adagen (Pegademase) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Adagen (Pegademase) 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 (7)
Life Threatening Events (3)
Disability (3)

Reports by Reaction Type

Autoimmune Thrombocytopenia (3)Lung Infection Pseudomonal (2)Therapeutic Response Decreased (2)Skin Papilloma (2)Peritoneal Haemorrhage (1)Anti-Platelet Antibody Positive (1)Pulmonary Alveolar Haemorrhage (1)Urticaria (1)Idiopathic Thrombocytopenic Purpura (1)

Possible Adagen side effects in 15 year old female

Reported by a physician from France on 2012-07-16

Patient: 15 year old female

Reactions: Anti-Platelet Antibody Positive, Autoimmune Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in 15 year old female

Reported by a physician from France on 2012-07-03

Patient: 15 year old female

Reactions: Autoimmune Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in 16 year old female

Reported by a physician from France on 2012-06-22

Patient: 16 year old female

Reactions: Autoimmune Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in 11 year old male

Reported by a physician from France on 2012-05-16

Patient: 11 year old male

Reactions: Therapeutic Response Decreased, Skin Papilloma, Lung Infection Pseudomonal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in male

Reported by a physician from France on 2012-05-04

Patient: male

Reactions: Therapeutic Response Decreased, Skin Papilloma, Lung Infection Pseudomonal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in 15 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-20

Patient: 15 year old female

Reactions: Peritoneal Haemorrhage, Pulmonary Alveolar Haemorrhage, Idiopathic Thrombocytopenic Purpura

Drug(s) suspected as cause:
Adagen



Possible Adagen side effects in 19 year old female

Reported by a consumer/non-health professional from United States on 2011-12-23

Patient: 19 year old female

Reactions: Urticaria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adagen

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