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