Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Thrombin (human)
Drug ID BADD_D02205
Description Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues. In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line [FDA Label]. Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride [FDA Label].
Indications and Usage Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical [FDA Label].
Marketing Status approved
ATC Code B02BD30; B02BC06
DrugBank ID DB11571
KEGG ID D00090
MeSH ID D013917
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 68225-108
UNII 25ADE2236L
Synonyms Thrombin | Thrombase | Thrombostat | alpha-Thrombin | Thrombin JMI | JMI, Thrombin | Thrombin-JMI | beta-Thrombin | gamma-Thrombin | Thrombinar | beta,gamma-Thrombin
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9002-04-4
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)
Activated partial thromboplastin time prolonged13.01.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Hypotension24.06.03.002--
International normalised ratio increased13.01.02.008--
Lymphocyte count decreased13.01.06.006--
Neutrophil count increased13.01.06.011---
Prothrombin time prolonged13.01.02.012---
Pruritus23.03.12.001--
Administration site discomfort08.02.04.010; 12.07.04.010---
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