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Vivaglobin Side Effects

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Common Vivaglobin Side Effects


The most commonly reported Vivaglobin side effects (click to view or check a box to report):

Headache (32)
Meningitis Aseptic (21)
Infusion Related Reaction (21)
Infusion Site Swelling (19)
Nausea (18)
Urticaria (16)
Infusion Site Erythema (15)
Erythema (14)
Cerebrovascular Accident (14)
Swelling (14)
Migraine (13)
Pain (13)
Dyspnoea (13)
Chest Pain (11)
Arthralgia (11)
Chills (11)
Oedema Peripheral (11)
Pruritus (11)
Injection Site Erythema (11)
Dizziness (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Vivaglobin Side Effects Reported to FDA



Vivaglobin Side Effect Report#9506000
Meningitis Aseptic, Myalgia, Arthralgia, Nausea, Vomiting
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: primary immunodeficiency syndrome,immunodeficiency common variable, who was treated with Vivaglobin (dosage: NA, start time: 200907), combined with: NA. and developed a serious reaction and side effect(s): Meningitis Aseptic, Myalgia, Arthralgia, Nausea, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in female patients, resulting in Meningitis Aseptic side effect. The patient was hospitalized.
Vivaglobin Side Effect Report#9505998
Meningitis Aseptic
This report suggests a potential Vivaglobin Meningitis Aseptic side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vivaglobin (dosage: NA) starting
Jul 11, 2008. After starting Vivaglobin the patient began experiencing various side effects, including: Meningitis AsepticAdditional drugs used concurrently: NA. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Meningitis Aseptic, may still occur.
Vivaglobin Side Effect Report#9505996
Deep Vein Thrombosis
This Deep Vein Thrombosis problem was reported by a physician from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: immunodeficiency common variable. On NS this consumer started treatment with Vivaglobin (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Deep Vein ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deep Vein Thrombosis, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#9161920
Meningitis Aseptic
This Meningitis Aseptic side effect was reported by a pharmacist from US. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivaglobin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Oxygen (oxygen)
  • Cymbalta (duloxetine Hydrochloride)
  • Fosamax (alendronate Sodium)
  • Singulair
  • Restasis (ciclosporin)
  • Lactulose (lactulose)
  • Furosemide (furosemide)
  • Prednisone (prednisone)
.After starting to take Vivaglobin the consumer reported adverse symptoms, such as: Meningitis AsepticThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#9160988
Lewis-sumner Syndrome, Disease Progression, Dysaesthesia, Paraesthesia, Muscular Weakness, Extensor Plantar Response, Injection Site Swelling, Injection Site Erythema
This is a report of a 51-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: lewis-sumner syndrome, who was treated with Vivaglobin (dosage: 9.6 G 1x/week, start time: NS), combined with:
  • Ass (acetylsalicylic Acid)
and developed a serious reaction and side effect(s): Lewis-sumner Syndrome, Disease Progression, Dysaesthesia, Paraesthesia, Muscular Weakness, Extensor Plantar Response, Injection Site Swelling, Injection Site Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in male patients, resulting in Lewis-sumner Syndrome side effect.
Vivaglobin Side Effect Report#9037045
Coeliac Disease, Gastrooesophageal Reflux Disease, Abdominal Pain Upper, Fatigue, Diarrhoea, Asthenia, Blood Immunoglobulin G Increased, Product Substitution Issue
This report suggests a potential Vivaglobin Coeliac Disease side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: NA and used Vivaglobin (dosage: NA) starting NS. After starting Vivaglobin the patient began experiencing various side effects, including: Coeliac Disease, Gastrooesophageal Reflux Disease, Abdominal Pain Upper, Fatigue, Diarrhoea, Asthenia, Blood Immunoglobulin G Increased, Product Substitution IssueAdditional drugs used concurrently: NA. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coeliac Disease, may still occur.
Vivaglobin Side Effect Report#8499413-0
Transmission Of An Infectious Agent Via A Medicinal Product, Herpes Simplex Serology Positive
This Transmission Of An Infectious Agent Via A Medicinal Product problem was reported by a physician from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 27, 2011 this consumer started treatment with Vivaglobin (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Transmission Of An Infectious Agent Via A Medicinal Product, Herpes Simplex Serology PositiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Transmission Of An Infectious Agent Via A Medicinal Product, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#8499393-8
Asthenia, Infusion Site Erythema, Infusion Site Swelling, Infusion Site Pruritus
This Asthenia side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivaglobin (drug dosage: (start: 36 Ml Weekly In 3 Sites In About 2 Hours Subcutaneous)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Vivaglobin the consumer reported adverse symptoms, such as: Asthenia, Infusion Site Erythema, Infusion Site Swelling, Infusion Site PruritusThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#8499279-9
Herpes Simplex Serology Positive, Transmission Of An Infectious Agent Via A Medicinal Product
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Vivaglobin (dosage: NA, start time:
Jan 26, 2011), combined with: NA. and developed a serious reaction and side effect(s): Herpes Simplex Serology Positive, Transmission Of An Infectious Agent Via A Medicinal Product after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in female patients, resulting in Herpes Simplex Serology Positive side effect.
Vivaglobin Side Effect Report#8487689-5
Headache, Dysphagia, Vertigo, Bone Pain, Disturbance In Attention, Vision Blurred, Ear Pain, Arthralgia, Syncope
This report suggests a potential Vivaglobin Headache side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from Sweden was diagnosed with the following symptoms/conditions: respiratory tract infection and used Vivaglobin (dosage: NA) starting
Sep 09, 2011. After starting Vivaglobin the patient began experiencing various side effects, including: Headache, Dysphagia, Vertigo, Bone Pain, Disturbance In Attention, Vision Blurred, Ear Pain, Arthralgia, SyncopeAdditional drugs used concurrently: NA. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Headache, may still occur.
Vivaglobin Side Effect Report#8461082
Thrombocytopenia, Graft Versus Host Disease, Bone Marrow Disorder, Cytomegalovirus Test Positive, White Blood Cell Count Increased, Polyuria, Polydipsia, Off Label Use
This Thrombocytopenia problem was reported by a health professional from FR. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia,immunisation. On
Jul 15, 2011 this consumer started treatment with Vivaglobin (dosage: 6.4 G 1x/week, 160mg/ml Every 7 Days Intravenous (not Otherwise Specified)). The following drugs were being taken at the same time:
  • Haemophilus B Conjugate Vaccine Nos
  • Haemophilus B Conjugate Vaccine Nos
  • Noxafil
  • Prednisone
  • Ganciclovir
  • Foscavir
When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Thrombocytopenia, Graft Versus Host Disease, Bone Marrow Disorder, Cytomegalovirus Test Positive, White Blood Cell Count Increased, Polyuria, Polydipsia, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombocytopenia, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#8450561-0
Product Contamination Microbial, Burning Sensation, Back Pain, Hypersensitivity, Dyspnoea
This Product Contamination Microbial side effect was reported by a health professional from Canada. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivaglobin (drug dosage: NA), which was initiated on
Mar 03, 2012. Concurrently used drugs: NA..After starting to take Vivaglobin the consumer reported adverse symptoms, such as: Product Contamination Microbial, Burning Sensation, Back Pain, Hypersensitivity, DyspnoeaThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#8381258-3
Pulmonary Vasculitis, Cutaneous Vasculitis, Vasculitis Cerebral
This is a report of a 26-year-old male patient (weight: NA) from Belgium, suffering from the following health symptoms/conditions: selective polysaccharide antibody deficiency, who was treated with Vivaglobin (dosage: 100 Mg/kg 1x/week Subcutaneous, start time:
Oct 08, 2008), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Vasculitis, Cutaneous Vasculitis, Vasculitis Cerebral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in male patients, resulting in Pulmonary Vasculitis side effect.
Vivaglobin Side Effect Report#8327427-X
Transmission Of An Infectious Agent Via A Medicinal Product, Herpes Simplex Serology Positive
This report suggests a potential Vivaglobin Transmission Of An Infectious Agent Via A Medicinal Product side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Vivaglobin (dosage: NA) starting
Aug 03, 2010. After starting Vivaglobin the patient began experiencing various side effects, including: Transmission Of An Infectious Agent Via A Medicinal Product, Herpes Simplex Serology PositiveAdditional drugs used concurrently: NA. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Transmission Of An Infectious Agent Via A Medicinal Product, may still occur.
Vivaglobin Side Effect Report#8303577-9
Pulmonary Vasculitis, Vasculitis Cerebral, Cutaneous Vasculitis
This Pulmonary Vasculitis problem was reported by a health professional from Belgium. A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 08, 2008 this consumer started treatment with Vivaglobin (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Pulmonary Vasculitis, Vasculitis Cerebral, Cutaneous VasculitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Vasculitis, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#8302472-9
Burning Sensation, Product Contamination Microbial, Back Pain, Dyspnoea, Hypersensitivity, Injection Site Pain
This Burning Sensation side effect was reported by a consumer or non-health professional from Canada. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: immunodeficiency.The patient was prescribed Vivaglobin (drug dosage: 30 Ml, At Rate Of 1ml/minute, Subcutaneous), which was initiated on
May 25, 2011. Concurrently used drugs:
  • Apo-hydroxyquine (hydroxychloroquine Sulfate)
  • Vitamin D
.After starting to take Vivaglobin the consumer reported adverse symptoms, such as: Burning Sensation, Product Contamination Microbial, Back Pain, Dyspnoea, Hypersensitivity, Injection Site PainThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#8200988-7
Haemoglobin Decreased, Polyuria, White Blood Cell Count Increased, White Blood Cell Count Decreased, Bone Marrow Disorder, Cytomegalovirus Test Positive, Off Label Use, Thrombocytopenia, Graft Versus Host Disease
This is a report of a 51-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Vivaglobin (dosage: 6.4 G 1x/week, Intravenous (not Otherwise Specified), 160mg/ml Every 7 Days, start time:
Oct 25, 2011), combined with:
  • Ganciclovir
  • Voriconazole
  • Prednisone Tab
  • Act Hib (haemophilus B Conjugate Vaccine)
and developed a serious reaction and side effect(s): Haemoglobin Decreased, Polyuria, White Blood Cell Count Increased, White Blood Cell Count Decreased, Bone Marrow Disorder, Cytomegalovirus Test Positive, Off Label Use, Thrombocytopenia, Graft Versus Host Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in male patients, resulting in Haemoglobin Decreased side effect. The patient was hospitalized.
Vivaglobin Side Effect Report#8184393-8
Headache
This report suggests a potential Vivaglobin Headache side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: immunodeficiency common variable and used Vivaglobin (dosage: See Image) starting
Feb 04, 2011. After starting Vivaglobin the patient began experiencing various side effects, including: HeadacheAdditional drugs used concurrently: NA. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Headache, may still occur.
Vivaglobin Side Effect Report#8184360-4
Migraine, Decreased Appetite, Dyspnoea, Insomnia, Dehydration
This Migraine problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: immunodeficiency common variable. On
Dec 01, 2010 this consumer started treatment with Vivaglobin (dosage: (40 Ml 1x/week Subcutaneous)). The following drugs were being taken at the same time: NA. When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Migraine, Decreased Appetite, Dyspnoea, Insomnia, DehydrationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Migraine, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#8184300-8
Convulsion
This Convulsion side effect was reported by a pharmacist from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivaglobin (drug dosage: NA), which was initiated on
Mar 01, 2010. Concurrently used drugs:
  • Phenobarbital Tab
  • Urocit-k Sr (potassium Citrate)
  • Keppra
.After starting to take Vivaglobin the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#8184281-7
Liver Function Test Abnormal, Hepatic Steatosis
This is a report of a 47-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Vivaglobin (dosage: NA, start time:
Jan 01, 2010), combined with: NA. and developed a serious reaction and side effect(s): Liver Function Test Abnormal, Hepatic Steatosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in female patients, resulting in Liver Function Test Abnormal side effect.
Vivaglobin Side Effect Report#8184238-6
Nausea, Back Pain, Infusion Site Swelling, Photophobia, Infusion Site Urticaria, Meningitis Aseptic, Headache
This report suggests a potential Vivaglobin Nausea side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: immunodeficiency common variable and used Vivaglobin (dosage: See Image) starting
Feb 01, 2007. After starting Vivaglobin the patient began experiencing various side effects, including: Nausea, Back Pain, Infusion Site Swelling, Photophobia, Infusion Site Urticaria, Meningitis Aseptic, HeadacheAdditional drugs used concurrently: NA.The patient was hospitalized. Although Vivaglobin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Vivaglobin Side Effect Report#8184196-4
Urticaria, Migraine, Musculoskeletal Stiffness, Meningitis Aseptic
This Urticaria problem was reported by a consumer or non-health professional from United States. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: selective igg subclass deficiency. On
Aug 13, 2010 this consumer started treatment with Vivaglobin (dosage: (subcutaneous)). The following drugs were being taken at the same time: NA. When using Vivaglobin, the patient experienced the following unwanted symptoms/side effects: Urticaria, Migraine, Musculoskeletal Stiffness, Meningitis AsepticAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urticaria, may become evident only after a product is in use by the general population.
Vivaglobin Side Effect Report#8155430-1
Eye Pain, Arthralgia, Vertigo, Ear Pain, Headache, Bone Pain, Vision Blurred, Fatigue, Off Label Use
This Eye Pain side effect was reported by a health professional from Sweden. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: respiratory tract infection.The patient was prescribed Vivaglobin (drug dosage: NA), which was initiated on
Sep 09, 2011. Concurrently used drugs: NA..After starting to take Vivaglobin the consumer reported adverse symptoms, such as: Eye Pain, Arthralgia, Vertigo, Ear Pain, Headache, Bone Pain, Vision Blurred, Fatigue, Off Label UseThese side effects may potentially be related to Vivaglobin.
Vivaglobin Side Effect Report#8115005-7
Malaise, Vision Blurred, Palpitations
This is a report of a 36-year-old female patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: primary immunodeficiency syndrome, who was treated with Vivaglobin (dosage: 8 G 1x/week, 16% Subcutaneous, start time:
May 11, 2010), combined with: NA. and developed a serious reaction and side effect(s): Malaise, Vision Blurred, Palpitations after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivaglobin treatment in female patients, resulting in Malaise side effect. The patient was hospitalized.


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The appearance of Vivaglobin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Vivaglobin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Vivaglobin Safety Alerts, Active Ingredients, Usage Information

    NDC0053-7596
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameVivaglobin
    NameHuman Immunoglobulin G
    Dosage FormSOLUTION
    RouteSUBCUTANEOUS
    On market since20060109
    LabelerCSL Behring LLC
    Active Ingredient(s)HUMAN IMMUNOGLOBULIN G
    Strength(s)160
    Unit(s)mg/mL
    Pharma ClassHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglo

    More About Vivaglobin

    Side Effects reported to FDA: 249

    Vivaglobin safety alerts: No

    Reported deaths: 9

    Reported hospitalizations: 114

    Latest Vivaglobin clinical trials