Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fragmin
Drug ID BADD_D00974
Description Dalteparin, a low molecular weight heparin (LMWH) prepared by nitrous acid degradation of unfractionated heparin of porcine intestinal mucosa origin, is an anticoagulant. It is composed of strongly acidic sulphated polysaccharide chains with an average molecular weight of 5000 and about 90% of the material within the range of 2000-9000. LMWHs have a more predictable response, a greater bioavailability, and a longer anti-Xa half life than unfractionated heparin. Dalteparin can also be safely used in most pregnant women. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.
Indications and Usage Dalteparin is used as a prophylaxis for deep-vein thrombosis and pulmonary embolisms in patients undergoing general surgery (e.g., abdominal, gynecologic, urologic), and in patients with acute medical conditions (e.g. cancer, bed rest, heart failure, severe lung disease). It is also used in patients who have severely restricted mobility, which poses a risk for thromboembolic complications. Dalteparin is also used concomitantly with aspirin and/or other therapy (e.g., nitrates, β-adrenergic blockers, clopidogrel, platelet glycoprotein [GP] IIb/IIIa-receptor inhibitors) to reduce the risk of acute cardiac ischemic events. The patients who undergo this treatment combination have unstable angina or non-ST-segment elevation/non-Q-wave myocardial infarction (i.e., non-ST-segment elevation acute coronary syndromes). It is also used in the prevention of clotting during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency.
Marketing Status approved
ATC Code B01AB04
DrugBank ID DB06779
KEGG ID D03353
MeSH ID D017985
PubChem ID 772
TTD Drug ID D08PSU
NDC Product Code Not Available
UNII 8NZ41MIK1O
Synonyms Dalteparin | Tedelparin | FR-860 | FR 860 | FR860 | Kabi-2165 | Kabi 2165 | Kabi2165 | Dalteparin Sodium | Sodium, Dalteparin | Fragmin | Fragmine
Chemical Information
Molecular Formula C26H42N2O37S5
CAS Registry Number 9005-49-6
SMILES CC(=O)NC1C(C(C(OC1O)COS(=O)(=O)O)OC2C(C(C(C(O2)C(=O)O)OC3C(C(C(C(O3)CO)OC4C(C(C( C(O4)C(=O)O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)NS(=O)(=O)O)O)OS(=O)(=O)O)O
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--
Abscess11.01.08.001---
Adrenal haemorrhage05.01.03.002; 12.01.17.003; 24.07.01.023---
Adrenocortical insufficiency acute05.01.02.005; 14.11.01.020---
Agranulocytosis01.02.03.001---
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Angina pectoris02.02.02.002; 24.04.04.002--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Aplasia cutis congenita03.05.01.011; 23.01.05.003---
Application site pain08.02.01.004; 12.07.01.004---
Arrhythmia02.03.02.001---
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Back pain15.03.04.005--
Blood calcium abnormal13.11.01.022---
Blood creatinine increased13.13.01.004--
Body temperature increased13.15.01.001---
Calcinosis08.03.04.002---
Cardiovascular disorder02.11.01.010; 24.03.02.009---
Cellulitis11.02.01.001; 23.11.02.004---
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.016--
Coagulation time prolonged13.01.02.006---
Coma17.02.09.001---
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