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Gamunex (Immune Globulin Intravenous Human) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gamunex (Immune Globulin Intravenous Human) 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 (60)
Death (1)
Life Threatening Events (2)

Reports by Reaction Type

Haemolytic Anaemia (7)Dyspnoea (6)Haemolysis (6)Antibody Test Positive (5)Infusion Related Reaction (5)Nausea (5)Hypotension (4)Thrombophlebitis (4)Chills (3)Encephalitis (3)Pulmonary Embolism (3)Headache (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Gamunex (Immune Globulin Intravenous Human). For a complete list or a specific selection of reports, please use the links above.

Possible Gamunex side effects in male

Reported by a pharmacist from United States on 2012-08-16

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Blood Pressure Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 59 year old female

Reported by a physician from Canada on 2012-08-06

Patient: 59 year old female

Reactions: Vomiting, Mycobacterial Infection, Nausea, Acalculia, Aphasia, Meningoencephalitis Herpetic, Dysgraphia, Meningitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex
    Dosage: 40 gm;iv
    Indication: Dermatomyositis
    Start date: 2012-05-01
    End date: 2012-05-01

Igivnex
    Dosage: 60 gm;iv
    Indication: Dermatomyositis
    Start date: 2012-04-30
    End date: 2012-05-01

Igivnex



Possible Gamunex side effects in 74 year old female

Reported by a physician from United States on 2012-07-23

Patient: 74 year old female

Reactions: Chills, Hypotension, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 14 year old female

Reported by a physician from United States on 2012-07-09

Patient: 14 year old female

Reactions: Encephalitis, Disorientation, Aggression, Antibody Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hizentra
    Dosage: see image
    Indication: Bruton's Agammaglobulinaemia
    Start date: 2011-06-02
    End date: 2012-03-26

Gamunex
    Dosage: (20 gm; 1 dose only)
    Start date: 2012-03-19
    End date: 2012-03-19

Keppra
    Indication: Convulsion
    End date: 2012-04-20



Possible Gamunex side effects in 14 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: 14 year old female

Reactions: Anti-GAD Antibody Positive, Encephalitis, Memory Impairment, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex
    Dosage: 20 gm;1x;iv
    Indication: Bruton's Agammaglobulinaemia
    Start date: 2012-03-19
    End date: 2012-03-19

Hizentra
    Dosage: 40 ml;qw;sc
    Indication: Bruton's Agammaglobulinaemia
    Start date: 2011-06-02
    End date: 2012-03-26

Other drugs received by patient: Keppra



Possible Gamunex side effects in 62 year old male

Reported by a physician from Canada on 2012-06-01

Patient: 62 year old male

Reactions: Haemoglobin Decreased, Haemorrhage Intracranial, Bone Marrow Failure, Haemolytic Anaemia, Thrombocytopenia, Antibody Test Positive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Valganciclovir HCL
    Administration route: Oral
    Indication: Cytomegalovirus Infection

Platelets
    Indication: Anaemia of Chronic Disease
    Start date: 2009-04-06
    End date: 2009-04-06

Gamunex
    Dosage: form: infusion
    Indication: Humoral Immune Defect
    Start date: 2009-04-06
    End date: 2009-04-06

Other drugs received by patient: Tamsulosin HCL; Tranexamic Acid; Codeine; Olanzapine; Lithium Carbonate; Omeprazole; Levothyroxine Sodium; Sertraline Hydrochloride; Digoxin; Granisetron; Zopiclone; Methylphenidate; Celecoxib; Acetaminophen



Possible Gamunex side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 56 year old female

Reactions: Drug Ineffective, Eye Swelling, Malignant Melanoma, Psoriasis, Feeling Abnormal, Infusion Related Reaction, Infection

Drug(s) suspected as cause:
Hizentra
    Indication: Immunodeficiency Common Variable
    Start date: 2011-01-01
    End date: 2011-06-01

Gamunex
    Indication: Immunodeficiency Common Variable
    Start date: 2011-06-01



Possible Gamunex side effects in male

Reported by a pharmacist from United States on 2012-05-17

Patient: male, weighing 81.4 kg (179.1 pounds)

Reactions: Gastrointestinal Disorder, Faecaloma

Drug(s) suspected as cause:
Gamunex

Gamunex
    Dosage: 65gm every 3 weeks iv
    Indication: Immunodeficiency Common Variable
    Start date: 2008-01-17
    End date: 2012-04-25



Possible Gamunex side effects in female

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

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Skin Disorder, Infusion Site Rash

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 14 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: 14 year old female

Reactions: Neurological Decompensation, Anti-GAD Antibody Positive, Abnormal Behaviour, Encephalitis, Memory Impairment, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex
    Dosage: (20 gm; 1 dose only)
    Start date: 2012-03-19
    End date: 2012-03-19

Hizentra
    Dosage: (40 ml 1x/week subcutaneous) ; (subcutaneous)
    Start date: 2011-06-02
    End date: 2012-03-01

Hizentra
    Dosage: (40 ml 1x/week subcutaneous) ; (subcutaneous)
    Start date: 2012-03-26

Keppra
    Indication: Convulsion
    End date: 2012-04-20



Possible Gamunex side effects in 40 year old female

Reported by a physician from United States on 2012-05-11

Patient: 40 year old female, weighing 53.5 kg (117.8 pounds)

Reactions: Productive Cough, Contusion, Chills, Wheezing, Oropharyngeal Pain, Pyrexia, Headache, Dizziness, Sputum Increased, Sneezing, Fluid Overload, Respiratory Rate Increased, Chest Discomfort, Dyspnoea, Flushing, Eye Swelling, Sputum Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex

Other drugs received by patient: Benadryl; Topamax; Singulair / 01362602 /; Nasacort; Estratest; Alprazolam; Qvar 40; Albuterol; Pepcid; Prednisone TAB; Tylenol (Caplet); Vitamin D; Imitrex / 01048801 /



Possible Gamunex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 32 year old male

Reported by a physician from United States on 2012-05-03

Patient: 32 year old male, weighing 150.6 kg (331.3 pounds)

Reactions: International Normalised Ratio Decreased, Splenic Embolism, Blood Albumin Decreased, Platelet Count Increased, Cardiolipin Antibody Positive, White Blood Cell Count Increased, Splenic Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex

Other drugs received by patient: Prednisone TAB; Cellcept; Lovenox



Possible Gamunex side effects in 42 year old female

Reported by a individual with unspecified qualification from Canada on 2012-05-03

Patient: 42 year old female, weighing 95.0 kg (209.0 pounds)

Reactions: Abdominal Discomfort, Palpitations, Drug Hypersensitivity

Drug(s) suspected as cause:
Gamunex
    Dosage: 95 gm;total;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2010-12-23
    End date: 2011-08-26

Gamunex

Gamunex

Other drugs received by patient: Benadryl; Prednisone TAB; Solu-Medrol; Imuran



Possible Gamunex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02

Patient: female

Reactions: Poikilocytosis, RED Blood Cell Burr Cells Present

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-26

Patient: female

Reactions: RED Blood Cell Burr Cells Present, Poikilocytosis

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 72 year old male

Reported by a individual with unspecified qualification from Germany on 2012-04-23

Patient: 72 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Pruritus, Rash Generalised, Drug Hypersensitivity, Vasculitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex
    Dosage: 81 gm;q3w;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-11-22
    End date: 2012-02-10

Gamunex

Other drugs received by patient: Levothyroxine Sodium; Pantoprazole



Possible Gamunex side effects in 53 year old male

Reported by a individual with unspecified qualification from Germany on 2012-04-16

Patient: 53 year old male, weighing 88.7 kg (195.1 pounds)

Reactions: Blood Pressure Increased, Body Temperature Increased, Chills, Vasculitis Necrotising, Condition Aggravated, Rash, Glomerulonephritis Proliferative, Leukocytoclastic Vasculitis, Malaise, Raynaud's Phenomenon, Cryoglobulinaemia, Normochromic Normocytic Anaemia, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gamunex

Gamunex

Gamunex

Gamunex

Gamunex
    Dosage: 60 gm;q3w;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-05-05
    End date: 2012-01-06

Gamunex

Gamunex

Gamunex

Other drugs received by patient: Pantoprazole; Cymbalta; Dekristol; Lyrica; Atacand HCT; Amlodipine



Possible Gamunex side effects in 60 year old male

Reported by a pharmacist from United States on 2012-04-16

Patient: 60 year old male

Reactions: Urinary Tract Infection, Haemolytic Anaemia, Neurological Symptom, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Immune Globulin (Human)
    Dosage: 5 gm;qd;iv
    Indication: Guillain-Barre Syndrome
    Start date: 2012-02-28
    End date: 2012-03-03

Gamunex
    Dosage: 40 gm;qd;iv
    Indication: Guillain-Barre Syndrome
    Start date: 2012-02-28
    End date: 2012-03-03

Other drugs received by patient: Toradol; Gabapentin



Possible Gamunex side effects in 6 year old female

Reported by a pharmacist from United States on 2012-04-09

Patient: 6 year old female, weighing 23.4 kg (51.5 pounds)

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 5 month old female

Reported by a pharmacist from United States on 2012-04-09

Patient: 5 month old female, weighing 6.0 kg (13.2 pounds)

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 19 year old female

Reported by a pharmacist from United States on 2012-04-05

Patient: 19 year old female, weighing 41.5 kg (91.3 pounds)

Reactions: RED Blood Cell Abnormality, Intravascular Haemolysis, Disseminated Intravascular Coagulation, Microangiopathic Haemolytic Anaemia, Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-05

Patient: male

Reactions: Renal Failure

Drug(s) suspected as cause:
Gamunex

Gamunex

Gamunex

Gamunex

Gamunex

Gamunex
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Gamunex

Gamunex



Possible Gamunex side effects in

Reported by a individual with unspecified qualification from United States on 2012-04-05

Patient:

Reactions: Product Label Issue, Medication Error

Drug(s) suspected as cause:
Gamunex
    Dosage: injection

Gamunex
    Dosage: injection



Possible Gamunex side effects in 17 year old male

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: 17 year old male

Reactions: Dyspnoea, Nausea, Pyrexia, Tremor, Anxiety, Malaise, Skin Discolouration, Muscle Spasms, Infusion Site Reaction

Drug(s) suspected as cause:
Gamunex

Other drugs received by patient: Zoloft; Diflucan



Possible Gamunex side effects in 57 year old female

Reported by a physician from Germany on 2012-03-20

Patient: 57 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Nausea, Drug Intolerance, Immunisation, Hepatitis A Antibody Positive, Hepatitis B Surface Antibody Positive, Dizziness, Hepatitis B Core Antibody Positive, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex
    Dosage: 20 gm;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2009-12-19
    End date: 2011-07-28

Privigen
    Dosage: 20 gm;x1;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2009-08-11
    End date: 2009-08-11

Igiv (Manufacture Unknown) (Immune Globulin IV (Human), Caprylate / Chro
    Dosage: x1;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-04-01
    End date: 2011-04-01

Other drugs received by patient: Cholecalciferol; Omeprazole; Magnesium; Bisoprolol Fumarate



Possible Gamunex side effects in 70 year old male

Reported by a physician from United States on 2012-03-20

Patient: 70 year old male, weighing 80.7 kg (177.6 pounds)

Reactions: Coronary Artery Occlusion, Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex

Gamunex
    Dosage: 80 gm;qow;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-06-02

Gamunex
    Dosage: 80 gm;qow;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-06-30

Gamunex
    Dosage: 80 gm;qow;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-07-18

Gamunex
    Dosage: 80 gm;qow;iv
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2011-06-16

Gamunex

Gamunex

Other drugs received by patient: Prednisone TAB; Paxil; Benadryl; Multi-Vitamins; Tylenol (Caplet)



Possible Gamunex side effects in 32 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-20

Patient: 32 year old male, weighing 150.6 kg (331.3 pounds)

Reactions: Abdominal Pain, Splenic Embolism, Blood Albumin Decreased, Platelet Count Increased, Aspartate Aminotransferase Decreased, Splenic Infarction, International Normalised Ratio Decreased, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex

Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Lovenox; Prednisone



Possible Gamunex side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-12

Patient: male

Reactions: Renal Failure

Drug(s) suspected as cause:
Gamunex



Possible Gamunex side effects in 61 year old male

Reported by a individual with unspecified qualification from Canada on 2012-03-01

Patient: 61 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Chest Pain, Haemolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gamunex

Gamunex

Gamunex

Gamunex

Igivnex
    Dosage: 90 gm;qd;iv
    Start date: 2011-10-26
    End date: 2011-10-26

Igivnex
    Dosage: 90 gm;qd;iv
    Start date: 2011-09-22
    End date: 2011-09-22

Gamunex
    Dosage: 90 gm;qd;iv
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-10-27
    End date: 2011-10-27

Gamunex
    Dosage: 90 gm;qd;iv
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-10-10
    End date: 2011-10-11

Gamunex
    Dosage: 90 gm;qd;iv
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-11-08
    End date: 2011-11-09

Gamunex
    Dosage: 90 gm;qd;iv
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-09-21
    End date: 2011-09-22

Gamunex

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