This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gammagard S / D (Immune Globulin Intravenous) 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 (26)
Death (5)
Life Threatening Events (1)
Disability (1)
Reports by Reaction Type
Malaise (7),
Chills (6),
Nausea (6),
Atrial Fibrillation (5),
Blood Pressure Increased (4),
Vomiting (4),
Hypotension (4),
Pain (3),
Headache (3),
Dizziness (3),
Transfusion-Related Acute Lung Injury (3),
Superior Sagittal Sinus Thrombosis (2)
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 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 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
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 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 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 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 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 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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