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Gammagard S / D (Immune Globulin Intravenous) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (26)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Gammagard S / D (Immune Globulin Intravenous) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Gammagard S / D side effects in male

Reported by a individual with unspecified qualification from Denmark on 2012-08-03

Patient: male

Reactions: Drug Ineffective, Headache, White Blood Cell Count Increased

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Narcolepsy
    Start date: 2011-02-14

Gammagard S / D
    Indication: Off Label Use



Possible Gammagard S / D side effects in female

Reported by a lawyer from United States on 2012-07-24

Patient: female

Reactions: Hepatitis C, Pain, Shock

Drug(s) suspected as cause:
Carimune
    Start date: 2007-03-21
    End date: 2007-03-24

Gammagard Liquid
    Start date: 2008-06-05
    End date: 2008-06-06

Gammagard Liquid
    Start date: 2007-07-18
    End date: 2007-07-21

Gammagard Liquid
    Start date: 2008-02-15

Gammagard Liquid
    Start date: 2007-07-01

Gammagard Liquid
    Start date: 2008-01-01

Gammagard Liquid
    Start date: 2008-04-02
    End date: 2008-04-04

Gammagard S / D
    Start date: 2007-07-18
    End date: 2007-07-21

Gammagard S / D
    Start date: 2008-01-01

Gammagard S / D
    Start date: 2008-02-15

Gammagard S / D
    Start date: 2008-06-05
    End date: 2008-06-06

Gammagard S / D
    Start date: 2007-07-01

Gammagard S / D
    Start date: 2008-04-02
    End date: 2008-04-04

Gammar
    Start date: 2003-11-14

Gammar
    Start date: 2003-11-11
    End date: 2003-11-12

Gammar
    Start date: 2004-09-28
    End date: 2004-09-30

Gammar
    Start date: 2004-12-21
    End date: 2004-12-23

Gammar
    Start date: 2003-12-22

Gammar
    Start date: 2004-10-27
    End date: 2004-10-29

Gammar
    Start date: 2003-10-07
    End date: 2003-10-08

Panglobulin
    Start date: 2007-03-21
    End date: 2007-03-24

Venoglobulin
    Start date: 2003-09-22

Venoglobulin
    Start date: 2003-06-30

Venoglobulin
    Start date: 2003-09-08
    End date: 2003-09-10

Venoglobulin
    Start date: 2003-08-11
    End date: 2003-08-13

Venoglobulin
    Start date: 2003-07-01
    End date: 2003-07-02

Venoglobulin
    Start date: 2003-07-31

Venoglobulin
    Start date: 2003-11-06

Venoglobulin
    Start date: 2003-09-05

Venoglobulin
    Start date: 2003-10-07
    End date: 2003-10-08

Venoglobulin
    Start date: 2003-11-10
    End date: 2003-11-12



Possible Gammagard S / D side effects in 20 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-29

Patient: 20 year old female

Reactions: Cerebral Venous Thrombosis, Superior Sagittal Sinus Thrombosis

Drug(s) suspected as cause:
Drospirenone and Ethinyl Estradiol

Gammagard S / D



Possible Gammagard S / D side effects in 20 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-27

Patient: 20 year old female

Reactions: Cerebral Venous Thrombosis, Superior Sagittal Sinus Thrombosis

Drug(s) suspected as cause:
Drospirenone and Ethinyl Estradiol

Gammagard S / D



Possible Gammagard S / D side effects in 82 year old male

Reported by a physician from United States on 2012-05-15

Patient: 82 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Pneumonia, Dyspnoea, Hypotension, Chills, Atrial Fibrillation, Hypoxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D



Possible Gammagard S / D side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-27

Patient: 62 year old female

Reactions: Agitation, Personality Change, Dysphagia, Hallucination, Auditory, Cerebellar Syndrome, Facial Pain, Blood Lactic Acid Increased, Chronic Lymphocytic Leukaemia, Hyperproteinaemia, Neoplasm Recurrence, Optic Neuropathy, Insomnia, Toxic Neuropathy, Blood Creatinine Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2003-01-01
    End date: 2006-05-01

Cyclophosphamide
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2009-04-01
    End date: 2009-04-01

Cyclophosphamide
    Administration route: Oral
    Start date: 2009-01-06
    End date: 2009-01-01

Cyclophosphamide
    Administration route: Oral
    Start date: 2009-02-25
    End date: 2009-02-01

Fludarabine Phosphate
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2009-04-01
    End date: 2009-04-01

Fludarabine Phosphate
    Administration route: Oral
    Start date: 2009-02-25
    End date: 2009-02-01

Fludarabine Phosphate
    Start date: 2010-04-17
    End date: 2010-04-21

Fludarabine Phosphate
    Administration route: Oral
    Start date: 2009-01-06
    End date: 2009-01-01

Fludarabine Phosphate
    Start date: 2005-11-01
    End date: 2006-05-01

Gammagard S / D
    Indication: Hypogammaglobulinaemia
    Start date: 2009-02-01

Mabthera
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2009-01-06
    End date: 2009-04-03

Other drugs received by patient: Vincristine; Doxorubicin HCL; Antilymphocyte Serum; Cyclosporine; Octagam; Busulfan; Prednisolone



Possible Gammagard S / D side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-02-20

Patient: male

Reactions: Anaphylactic Shock

Drug(s) suspected as cause:
Gammagard S / D



Possible Gammagard S / D side effects in 82 year old male

Reported by a physician from United States on 2012-02-20

Patient: 82 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Dyspnoea, Pneumonia, Hypotension, Chills, Atrial Fibrillation, Hypoxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D



Possible Gammagard S / D side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-02-09

Patient: 77 year old female

Reactions: Blood Pressure Increased, Transfusion-Related Acute Lung Injury, Vomiting, Nausea, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Immunodeficiency Common Variable
    Start date: 2011-11-15
    End date: 2011-11-15

Gammagard S / D
    Start date: 2003-09-01



Possible Gammagard S / D side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-09

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Foetal Exposure Timing Unspecified

Gammagard S / D
    Indication: Off Label Use



Possible Gammagard S / D side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-09

Patient: 36 year old female

Reactions: Maternal Death During Childbirth, Maternal Exposure During Pregnancy, Premature Labour

Adverse event resulted in: death

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Toxic Shock Syndrome Streptococcal

Gammagard S / D
    Indication: Off Label Use



Possible Gammagard S / D side effects in 32 year old male

Reported by a physician from United States on 2012-02-07

Patient: 32 year old male

Reactions: Malaise, Anaemia, Haemolysis

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

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Immunodeficiency Common Variable
    Start date: 2011-05-01

Gammagard S / D
    Start date: 2011-12-08

Other drugs received by patient: Augmentin '125'



Possible Gammagard S / D side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-02

Patient: 39 year old male

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Pemphigus

Gammagard S / D
    Indication: Off Label Use

Other drugs received by patient: Prednisolone



Possible Gammagard S / D side effects in female

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

Patient: female

Reactions: Vomiting, Incorrect Drug Administration Duration, Wrong Technique in Drug Usage Process, Nausea, Headache, Sinusitis, Stress

Drug(s) suspected as cause:
Gammagard S / D



Possible Gammagard S / D 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:
Albumin (Human)
    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

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

Buminate 5%
    Start date: 2011-10-01

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

Gammagard S / D
    Indication: Post Procedural Infection



Possible Gammagard S / D side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-10

Patient: 77 year old female

Reactions: Blood Pressure Increased, Transfusion-Related Acute Lung Injury, Vomiting, Nausea, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Immunodeficiency Common Variable
    Start date: 2011-11-15
    End date: 2011-11-15

Gammagard S / D
    Start date: 2003-09-01



Possible Gammagard S / D side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-29

Patient: 39 year old male

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Gammagard S / D
    Indication: Pemphigus

Gammagard S / D
    Indication: Off Label Use

Other drugs received by patient: Prednisolone



Possible Gammagard S / D side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-29

Patient: 77 year old female

Reactions: Blood Pressure Increased, Transfusion-Related Acute Lung Injury, Vomiting, Nausea, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D



Possible Gammagard S / D side effects in 50 year old female

Reported by a pharmacist from United States on 2011-11-21

Patient: 50 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Malaise, Pain in Extremity, Pain, Bone Pain, Chills, Musculoskeletal Stiffness, Meningitis Aseptic

Drug(s) suspected as cause:
Gammagard S / D

Other drugs received by patient: Multi-Vitamins; Zithromax



Possible Gammagard S / D side effects in 85 year old male

Reported by a physician from Germany on 2011-11-17

Patient: 85 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Chest Pain, Ventricular Fibrillation, Loss of Consciousness

Adverse event resulted in: death

Drug(s) suspected as cause:
Gammagard Liquid
    Indication: Immunoglobulin Therapy
    Start date: 2011-08-01
    End date: 2011-09-22

Gammagard Liquid
    Indication: Humoral Immune Defect
    Start date: 2011-08-01
    End date: 2011-09-22

Gammagard S / D
    Indication: Immunoglobulin Therapy
    Start date: 2011-09-22
    End date: 2011-09-22

Gammagard S / D
    Indication: Humoral Immune Defect
    Start date: 2011-09-22
    End date: 2011-09-22

Octagam
    Indication: Humoral Immune Defect
    Start date: 2011-09-22

Other drugs received by patient: Methylprednisolone



Possible Gammagard S / D side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-03

Patient: 18 year old female, weighing 91.0 kg (200.2 pounds)

Reactions: Malaise, Bronchitis, Sinusitis

Drug(s) suspected as cause:
Gammagard S / D

Other drugs received by patient: Vyvanse



Possible Gammagard S / D side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-03

Patient: 75 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Blood Pressure Increased, Dysphagia, Chills, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Gammagard S / D

Other drugs received by patient: Tylenol-500; Benadryl HCL; Solu-Medrol



Possible Gammagard S / D side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-11-01

Patient: 68 year old female

Reactions: Weight Increased, Malaise, Cardiac Failure, Nausea, Hypotension, Dizziness, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gammagard S / D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Indication: Off Label Use
    Start date: 2009-03-06
    End date: 2009-03-06

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Indication: Myositis
    Start date: 2009-03-06
    End date: 2009-03-06

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Other drugs received by patient: Lasix



Possible Gammagard S / D side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-10-20

Patient: 68 year old female

Reactions: Weight Increased, Malaise, Nausea, Cardiac Failure, Hypotension, Dizziness, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammagard S / D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Indication: Myositis
    Start date: 2009-03-06
    End date: 2009-03-06

Gammagard S / D
    Dosage: 1 x per 21 dagen
    Indication: Off Label Use
    Start date: 2009-03-06
    End date: 2009-03-06

Other drugs received by patient: Lasix



Possible Gammagard S / D side effects in 50 year old female

Reported by a pharmacist from United States on 2011-10-14

Patient: 50 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Malaise, Pain in Extremity, Bone Pain, Chills, Pain, Musculoskeletal Stiffness, Meningitis Aseptic

Drug(s) suspected as cause:
Gammagard S / D

Other drugs received by patient: Multi-Vitamins; Zithromax



Possible Gammagard S / D side effects in 85 year old male

Reported by a physician from Germany on 2011-10-03

Patient: 85 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Chills, Headache, Loss of Consciousness, Malaise, Chest Pain, Dizziness, Vision Blurred, Ventricular Fibrillation

Adverse event resulted in: death

Drug(s) suspected as cause:
Gammagard Liquid
    Indication: Immunoglobulin Therapy
    Start date: 2011-08-01
    End date: 2011-09-22

Gammagard S / D
    Indication: Immunoglobulin Therapy
    Start date: 2011-09-22

Octagam
    Indication: Immunoglobulin Therapy
    Start date: 2011-09-22

Other drugs received by patient: Methylprednisolone

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