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Immunoglobulin Side Effects

Common Immunoglobulin Side Effects


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

Therapeutic Response Decreased (12)
Death (10)
Thrombocytopenia (9)
Haemoglobin Decreased (8)
Pyrexia (7)
Platelet Count Decreased (7)
Asthenia (6)
Anaemia (6)
Arthralgia (6)
Back Pain (6)
Idiopathic Thrombocytopenic Purpura (6)
Hypotension (6)
Rash Erythematous (6)
Myelodysplastic Syndrome (6)
Bone Disorder (5)
Headache (5)
Ecchymosis (5)
Bone Marrow Reticulin Fibrosis (5)
Haemorrhage (5)
Dyspnoea (5)

➢ 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.

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.

Immunoglobulin Side Effects Reported to FDA

The following Immunoglobulin 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.


The appearance of Immunoglobulin 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.
Hypertensive Emergency, Thrombosis, Subclavian Vein Thrombosis, Sepsis, Nephrotic Syndrome, Glomerulonephritis Membranous
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: hypogammaglobulinaemia, who was treated with Immunoglobulin (dosage: Monthly Infusion, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypertensive Emergency
  • Thrombosis
  • Subclavian Vein Thrombosis
  • Sepsis
  • Nephrotic Syndrome
  • Glomerulonephritis Membranous
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Immunoglobulin treatment in female patients, resulting in hypertensive emergency side effect.

Hypertensive Emergency, Thrombosis, Subclavian Vein Thrombosis, Sepsis, Nephrotic Syndrome, Glomerulonephritis Membranous
This report suggests a potential Immunoglobulin Hypertensive Emergency, Thrombosis, Subclavian Vein Thrombosis, Sepsis, Nephrotic Syndrome, Glomerulonephritis Membranous side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypogammaglobulinaemia and used Immunoglobulin (dosage: Monthly Infusion) starting NS. Soon after starting Immunoglobulin the patient began experiencing various side effects, including:
  • Hypertensive Emergency
  • Thrombosis
  • Subclavian Vein Thrombosis
  • Sepsis
  • Nephrotic Syndrome
  • Glomerulonephritis Membranous
Drugs used concurrently: NA. Although Immunoglobulin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypertensive emergency, may still occur.

Hypertensive Emergency, Thrombosis, Subclavian Vein Thrombosis, Sepsis, Nephrotic Syndrome, Glomerulonephritis Membranous
This Hypertensive Emergency, Thrombosis, Subclavian Vein Thrombosis, Sepsis, Nephrotic Syndrome, Glomerulonephritis Membranous problem was reported by a health professional from US. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypogammaglobulinaemia. On NS this consumer started treatment with Immunoglobulin (dosage: Monthly Infusion). The following drugs were being taken at the same time: NA. When commencing Immunoglobulin, the patient experienced the following unwanted symptoms/side effects:
  • Hypertensive Emergency
  • Thrombosis
  • Subclavian Vein Thrombosis
  • Sepsis
  • Nephrotic Syndrome
  • Glomerulonephritis Membranous
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hypertensive emergency, may become evident only after a product is in use by the general population.

Haemorrhage, Haemoglobin Decreased, Melaena, Purpura, Rash Erythematous, Rash Maculo-papular, Rectal Haemorrhage, Vaginal Haemorrhage, Arthralgia
This is a report of a 34-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Immunoglobulin Human Anti D (dosage: NA) starting Sep 22, 2010. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Haemorrhage
  • Haemoglobin Decreased
  • Melaena
  • Purpura
  • Rash Erythematous
  • Rash Maculo-papular
  • Rectal Haemorrhage
  • Vaginal Haemorrhage
  • Arthralgia
The patient was hospitalized. This opens a possibility that Immunoglobulin Human Anti D treatment could cause the above reactions, including haemorrhage, and some female subjects may be more susceptible.


Haemorrhage, Purpura, Melaena, Rectal Haemorrhage, Vaginal Haemorrhage, Rash Maculo-papular, Rash Erythematous, Haemoglobin Decreased, Arthralgia
A 33-year-old female patient (weight: NA) from GB with the following symptoms/conditions: immune thrombocytopenic purpura,gastrooesophageal reflux prophylaxis started Immunoglobulin treatment (dosage: NA) on Sep 07, 2010. Soon after starting Immunoglobulin treatment, the subject experienced various side effects, including:
  • Haemorrhage
  • Purpura
  • Melaena
  • Rectal Haemorrhage
  • Vaginal Haemorrhage
  • Rash Maculo-papular
  • Rash Erythematous
  • Haemoglobin Decreased
  • Arthralgia
Concurrently used drugs:
  • Lansoprazole
  • Norethindrone
  • Nplate (romiplostim)
  • Rituximab
  • Tranexamic Acid
  • Dexamethasone
  • Anti-d Immunoglobulin
  • Vincristine Sulfate
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Immunoglobulin.

Asthma, Pyrexia, Headache, Meningitis Aseptic, Cough, Sinusitis
A 15-year-old female patient from JP (weight: NA) experienced symptoms, such as: primary immunodeficiency syndrome and was treated with Immunoglobulin Human Normal(dosage: NA). The treatment was initiated on Jan 30, 2012. After that a consumer reported the following side effect(s):
  • Asthma
  • Pyrexia
  • Headache
  • Meningitis Aseptic
  • Cough
  • Sinusitis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Immunoglobulin Human Normal efficacy:
  • Mucodyne(carbocisteine)
  • Calrith(clarithromycin)
  • Leftose/(lysozyme)
The patient was hospitalized.

Viral Myocarditis, Epstein-barr Virus Infection
In this report, Immunoglobulins was administered for the following condition: epstein-barr virus infection.A 40-year-old female consumer from DE (weight: NA) started Immunoglobulins treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Viral Myocarditis
  • Epstein-barr Virus Infection
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Immunoglobulins treatment could be related to the listed above side effect(s).

Chest Discomfort, Respiratory Muscle Weakness, Dysphagia, Aspiration
This is a report of the following Immunoglobulin side effect(s):
  • Chest Discomfort
  • Respiratory Muscle Weakness
  • Dysphagia
  • Aspiration
A 54-year-old male patient from CO (weight: NA) presented with the following condition: cranial nerve disorder and received a treatment with Immunoglobulin (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Immunoglobulin treatment could be associated with the listed above side effect(s).

Anaphylactic Reaction, Off Label Use, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
This Immunoglobulin report was submitted by a 12-year-old male consumer from KW (weight: NA). The patient was diagnosed with: pityriasis lichenoides et varioliformis acuta and Immunoglobulin was administered (dosage: 400 Mg/kg Qd, Intravenous (not Otherwise Specified)) starting: NS. The consumer developed a set of symptoms:
  • Anaphylactic Reaction
  • Off Label Use
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
Other drugs used simultaneously:
  • Clarithromycin (clarithromycin)?
Those unexpected symptoms could be linked to a Immunoglobulin treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Anaphylactic Reaction, Off Label Use, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
This is a report of a possible correlation between Immunoglobulin use and the following symptoms/side effect(s):
  • Anaphylactic Reaction
  • Off Label Use
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
which could contribute to an assessment of Immunoglobulin risk profile.A 12-year-old male consumer from KW (weight: NA) was suffering from pityriasis lichenoides et varioliformis acuta and was treated with Immunoglobulin (dosage: NA) starting NS.Other concurrent medications:
  • Clarithromycin (clarithromycin)


Bronchopulmonary Aspergillosis, Pulmonary Mass
A 69-year-old male patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Immunoglobulin (dosage: NA) experienced the following side effect(s):
  • Bronchopulmonary Aspergillosis
  • Pulmonary Mass
The treatment was started on NS. Immunoglobulin was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Immunoglobulin consumers.

Bronchopulmonary Aspergillosis, Ecchymosis
In this report, a 69-year-old male patient from US (weight: NA) was affected by a possible Immunoglobulin side effect.The patient was diagnosed with idiopathic thrombocytopenic purpura,epistaxis. After a treatment with Immunoglobulin (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Bronchopulmonary Aspergillosis
  • Ecchymosis
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Immunoglobulin treatment.

Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness
This is a report of a 67-year-old male patient from DK (weight: NA), who used Immunoglobulin (dosage: NA) for a treatment of blood disorder,worms. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Neutrophil Count Decreased
  • Pharyngeal Erythema
  • Influenza Like Illness
The following drugs could possibly have interacted with the Immunoglobulin treatment
  • Vermox ((1x 1/cyclical))
Taken together, these observations suggest that a Immunoglobulin treatment could be related to side effect(s), such as Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness.

Haemoglobin Decreased, Blood Lactate Dehydrogenase Increased, Haemoglobinuria, Bone Pain, Reticulocyte Count Increased
This haemoglobin decreased side effect was reported by a consumer or non-health professional from IT. A 26-year-old male patient (weight:NA) experienced the following symptoms/conditions: delayed haemolytic transfusion reaction. The patient was prescribed Immunoglobulin (dosage: Intraintr), which was started on 201206. Concurrently used drugs: NA. When starting to take Immunoglobulin the consumer reported the following symptoms:
  • Haemoglobin Decreased
  • Blood Lactate Dehydrogenase Increased
  • Haemoglobinuria
  • Bone Pain
  • Reticulocyte Count Increased
These side effects may potentially be related to Immunoglobulin.

Chest Pain, Dyspnoea, Cough
This is a Immunoglobulin, Normal Human Liquid 0.2 G/ml Solution For Injection Vial (immunoglobulin, Normal Hum side effect report of a 52-year-old female patient (weight:NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: NA, who was treated with Immunoglobulin, Normal Human Liquid 0.2 G/ml Solution For Injection Vial (immunoglobulin, Normal Hum (dosage:NA, start time: 1999), combined with: NA., and developed a serious reaction and a chest pain side effect. The patient presented with:
  • Chest Pain
  • Dyspnoea
  • Cough
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Immunoglobulin, Normal Human Liquid 0.2 G/ml Solution For Injection Vial (immunoglobulin, Normal Hum treatment in female patients suffering from NA, resulting in chest pain.

Malaise, Infusion Site Pain, Sinus Congestion, Abdominal Pain Upper, Ear Infection
This report suggests a potential Immunoglobulin Human Normal malaise side effect(s) that can have serious consequences. A 9-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Immunoglobulin Human Normal (dosage: 6g 1x/week, 2 Grams Subcutaneous) starting Dec 20, 2012. Soon after starting Immunoglobulin Human Normal the patient began experiencing various side effects, including:
  • Malaise
  • Infusion Site Pain
  • Sinus Congestion
  • Abdominal Pain Upper
  • Ear Infection
Drugs used concurrently:NA. The patient was hospitalized. Although Immunoglobulin Human Normal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as malaise, may still occur.

Infusion Site Urticaria, Fatigue, Arthralgia, Condition Aggravated, Migraine, Diarrhoea, Nausea, Pneumonia, Pleurisy
This infusion site urticaria problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Immunoglobulin Human Normal (dosage: 1x/week, Oct-2008: 80 Ml Weekly In 5 Sites Over 2 Hours). The following drugs/medications were being taken at the same time:
  • Oxycontin (oxycodone Hydrochloride)
  • Cymbalta (duloxetine Hydrochloride)
  • Amoxicillin (amoxicillin)
  • Advair 250/50 (seretide /01420901/)
  • Proventil (salbutamol)
  • Valtrex (valaciclovir Hydrochloride)
  • Premarin (estrogens Conjugated)
  • Levothyroxine (levothyroxine)
When commencing Immunoglobulin Human Normal, the patient experienced the following unwanted symptoms /side effects:
  • Infusion Site Urticaria
  • Fatigue
  • Arthralgia
  • Condition Aggravated
  • Migraine
  • Diarrhoea
  • Nausea
  • Pneumonia
  • Pleurisy
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as infusion site urticaria, may become evident only after a product is in use by the general population.

Glioblastoma Multiforme, No Therapeutic Response
This is a Immunoglobulin side effect report of a 49-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Immunoglobulin (dosage: NA) starting NS. Concurrently used drugs:
  • Corticosteroid
Soon after that, the consumer experienced the following of symptoms:
  • Glioblastoma Multiforme
  • No Therapeutic Response
The patient was hospitalized. This opens a possibility that Immunoglobulin could cause glioblastoma multiforme and that some male patients may be more susceptible.

Respiratory Disorder, No Therapeutic Response, Glioblastoma Multiforme
A 49-year-old male patient (weight: NA) from US with the following symptoms: myelitis transverse started Immunoglobulin treatment (dosage: NA) on NS. Soon after starting Immunoglobulin treatment, the consumer experienced several side effects, including:
  • Respiratory Disorder
  • No Therapeutic Response
  • Glioblastoma Multiforme
. Concurrently used drugs:
  • Steroid
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Immunoglobulin side effects, such as respiratory disorder.

Oral Mucosal Blistering, Condition Aggravated, Face Oedema
This oral mucosal blistering side effect was reported by a consumer or non-health professional from GB. A 7-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Immunoglobulin Intravenous Human (dosage: Single Infusion), which was started on NS. Concurrently used drugs:
  • Sodium Valproate (valproate Sodium)
  • Carbamazepine (carbamazepine) Indication For Use Was Epilepsy
.When starting to take Immunoglobulin Intravenous Human the consumer reported symptoms, such as:
  • Oral Mucosal Blistering
  • Condition Aggravated
  • Face Oedema
These side effects may potentially be related to Immunoglobulin Intravenous Human.

Grand Mal Convulsion, Headache
This is a report of a 47-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Immunoglobulin Intravenous Human (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Grand Mal Convulsion
  • Headache
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Immunoglobulin Intravenous Human treatment in female patients, resulting in grand mal convulsion side effect.

Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness, Off Label Use
This report suggests a potential Immunoglobulin G Human Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness, Off Label Use side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: blood disorder,worms and used Immunoglobulin G Human (dosage: NA) starting NS. Soon after starting Immunoglobulin G Human the patient began experiencing various side effects, including:
  • Neutrophil Count Decreased
  • Pharyngeal Erythema
  • Influenza Like Illness
  • Off Label Use
Drugs used concurrently:
  • Vermox
Although Immunoglobulin G Human demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as neutrophil count decreased, may still occur.

Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness
This Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness problem was reported by a consumer or non-health professional from DK. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood disorder,worms. On NS this consumer started treatment with Immunoglobulin G Human (dosage: NA). The following drugs were being taken at the same time:
  • Mebendazole
When commencing Immunoglobulin G Human, the patient experienced the following unwanted symptoms/side effects:
  • Neutrophil Count Decreased
  • Pharyngeal Erythema
  • Influenza Like Illness
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as neutrophil count decreased, may become evident only after a product is in use by the general population.

Neutrophil Count Decreased, Pharyngeal Erythema, Influenza Like Illness
This is a report of a 67-year-old male patient (weight: NA) from DK. The patient developed the following symptoms/conditions: blood disorder,worms and was treated with Immunoglobulin G Human (dosage: NA) starting NS. Concurrently used drugs:
  • Mebendazole
Soon after that, the consumer experienced the following side effects:
  • Neutrophil Count Decreased
  • Pharyngeal Erythema
  • Influenza Like Illness
This opens a possibility that Immunoglobulin G Human treatment could cause the above reactions, including neutrophil count decreased, and some male subjects may be more susceptible.

Nephrotic Syndrome, Skin Exfoliation
A 4-year-old male patient (weight: NA) from FR with the following symptoms/conditions: kawasaki^s disease started Immunoglobulin treatment (dosage: NA) on NS. Soon after starting Immunoglobulin treatment, the subject experienced various side effects, including:
  • Nephrotic Syndrome
  • Skin Exfoliation
Concurrently used drugs:
  • Acetylsalicylic Acid
This finding indicates that some male patients could be more vulnerable to Immunoglobulin.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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    More About Immunoglobulin

    Side Effects reported to FDA: 124

    Immunoglobulin safety alerts: No

    Reported deaths: 32

    Reported hospitalizations: 40

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