Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Immunoglobulin (human)
Drug ID BADD_D01144
Description Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.
Indications and Usage IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases.
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB00028
KEGG ID D06458
MeSH ID D007136
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 44206-451; 44206-457; 69800-0250; 64208-8234; 44206-438; 64208-8235; 44206-454; 44206-452; 44206-456; 44206-436; 44206-437; 44206-439; 44206-455; 44206-458
UNII Not Available
Synonyms Immunoglobulins | Globulins, Immune | Immunoglobulin | Immune Globulin | Globulin, Immune | Immune Globulins
Chemical Information
Molecular Formula Not Available
CAS Registry Number 308067-58-5
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.001--
Apnoea22.02.01.001--
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Blood pressure abnormal13.14.03.001--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiac arrest02.03.04.001--
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.009--Not Available
Chills08.01.09.001; 15.05.03.016--
Circulatory collapse24.06.02.001--Not Available
Coma17.02.09.001--Not Available
Coombs direct test13.01.01.006--Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.007--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema multiforme23.03.01.003; 10.01.03.015--
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Haemolysis01.06.04.002--
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Insomnia19.02.01.002; 17.15.03.002--
Leukopenia01.02.02.001--Not Available
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