Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hepatitis b immune globulin (human)
Drug ID BADD_D01062
Description Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.
Indications and Usage Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications.
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB05276
KEGG ID Not Available
MeSH ID C045213
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 69800-4203; 13533-636; 69800-4202
UNII Not Available
Synonyms hepatitis B hyperimmune globulin | human hepatitis B virus immune globulin | HBIG | hepatect
Chemical Information
Molecular Formula Not Available
CAS Registry Number Not Available
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)
Sepsis11.01.11.003--
Splenomegaly01.09.02.001---
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tremor17.01.06.002--
Vomiting07.01.07.003--
Hepatobiliary disease09.01.08.003---
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