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Buminate 5% (Albumin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Buminate 5% (Albumin) 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 (6)

Reports by Reaction Type

Hepatitis C (2)Dyspnoea (1)Hepatitis C Antibody Positive (1)Body Temperature Increased (1)Alanine Aminotransferase Increased (1)Tremor (1)Creutzfeldt-Jakob Disease (1)Aspartate Aminotransferase Increased (1)Sepsis (1)Upper Gastrointestinal Haemorrhage (1)Cardiac Failure Congestive (1)Post Procedural Infection (1)

Possible Buminate 5% side effects in

Reported by a individual with unspecified qualification from Japan on 2012-08-07

Patient:

Reactions: Upper Gastrointestinal Haemorrhage, Cardiac Failure Congestive

Drug(s) suspected as cause:
Buminate 5%
    Indication: Hepatorenal Syndrome

Glypressin
    Indication: Hepatorenal Syndrome



Possible Buminate 5% side effects in

Reported by a pharmacist from Japan on 2012-01-12

Patient:

Reactions: Hepatitis C Antibody Positive, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Post Procedural Infection

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Post Procedural Infection

Blood and Related Products
    Indication: Transfusion
    Start date: 2011-10-01

Blood and Related Products
    Indication: Surgery
    Start date: 2011-10-01

Fibrin Sealant, MFG Unspecified
    Indication: Surgery
    Start date: 2011-10-01

Albumin (Human)
    Indication: Post Procedural Infection

Buminate 5%
    Indication: Surgery
    Start date: 2011-10-01

Buminate 5%
    Start date: 2011-10-01



Possible Buminate 5% side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-07

Patient:

Reactions: Hepatitis C

Drug(s) suspected as cause:
Buminate 5%

Buminate 5%
    Indication: Product Used FOR Unknown Indication



Possible Buminate 5% side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-27

Patient:

Reactions: Hepatitis C

Drug(s) suspected as cause:
Buminate 5%
    Indication: Product Used FOR Unknown Indication

Buminate 5%



Possible Buminate 5% side effects in 32 year old

Reported by a pharmacist from Japan on 2011-10-24

Patient: 32 year old , weighing 71.0 kg (156.2 pounds)

Reactions: Dyspnoea, Body Temperature Increased, Sepsis, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buminate 5%
    Start date: 2011-07-21
    End date: 2011-07-21

Buminate 5%
    Indication: Plasmapheresis
    Start date: 2011-07-19
    End date: 2011-07-19



Possible Buminate 5% side effects in 73 year old male

Reported by a pharmacist from Japan on 2011-10-04

Patient: 73 year old male

Reactions: Creutzfeldt-Jakob Disease

Drug(s) suspected as cause:
Buminate 5%
    Start date: 2000-12-15
    End date: 2000-12-17

RED Blood Cells, Concentrated
    Indication: Anaemia Postoperative
    Start date: 2000-12-09
    End date: 2000-12-11

Buminate 5%
    Indication: Hypoalbuminaemia
    Start date: 2000-12-12
    End date: 2000-12-14

Beriplast
    Administration route: Topical
    Indication: Tissue Sealing
    Start date: 2000-12-07
    End date: 2000-12-07

Other drugs received by patient: RED Blood Cells, Concentrated; Beriplast

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