{"id":"bemiparin","rwe":[{"pmid":"41197582","year":"2025","title":"Effect of Intra-arterial Bemiparin Sodium on Intestinal Ischemia-Reperfusion Injury: Animal Model.","finding":"","journal":"The Journal of surgical research","studyType":"Clinical Study"},{"pmid":"41034645","year":"2025","title":"Neonatal morbidity in early-onset fetal growth restriction with and without anticoagulant therapy.","finding":"","journal":"Pediatric research","studyType":"Clinical Study"},{"pmid":"40713472","year":"2025","title":"Whether an optimal strategy exists for VTE prevention in critically ill patients: Insights from guidelines and randomized controlled trials.","finding":"","journal":"European journal of internal medicine","studyType":"Clinical Study"},{"pmid":"40630816","year":"2025","title":"Anti-PF4/ Heparin Antibodies Early Seroconversion in Hip Fracture Patients Receiving Low Molecular Weight Heparin Prophylaxis: a Pilot Study of 100 Consecutive Patients.","finding":"","journal":"The archives of bone and joint surgery","studyType":"Clinical Study"},{"pmid":"40289279","year":"2025","title":"Influence of anticoagulant concomitant medication on wound healing: Analysis of a multicentre cohort of 212 patients with a uniform wound model.","finding":"","journal":"British journal of clinical pharmacology","studyType":"Clinical Study"}],"tags":[{"label":"Low Molecular Weight Heparin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"B01AB10","category":"atc"},{"label":"Subcutaneous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Deep venous thrombosis","category":"indication"},{"label":"Pulmonary embolism","category":"indication"},{"label":"Pfizer Inc","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anticoagulants","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Fibrinolytic Agents","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":434.927,"date":"","count":562,"signal":"Pulmonary embolism","source":"DrugCentral FAERS","actionTaken":"Reported 562 times (LLR=435)"},{"llr":410.827,"date":"","count":163,"signal":"Appendicolith","source":"DrugCentral FAERS","actionTaken":"Reported 163 times (LLR=411)"},{"llr":345.254,"date":"","count":650,"signal":"General physical health deterioration","source":"DrugCentral FAERS","actionTaken":"Reported 650 times (LLR=345)"},{"llr":336.271,"date":"","count":244,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 244 times (LLR=336)"},{"llr":272.265,"date":"","count":63,"signal":"Device operational issue","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=272)"},{"llr":270.654,"date":"","count":169,"signal":"Appendicitis","source":"DrugCentral FAERS","actionTaken":"Reported 169 times (LLR=271)"},{"llr":260.287,"date":"","count":148,"signal":"Needle issue","source":"DrugCentral FAERS","actionTaken":"Reported 148 times (LLR=260)"},{"llr":258.811,"date":"","count":219,"signal":"Hepatocellular injury","source":"DrugCentral FAERS","actionTaken":"Reported 219 times (LLR=259)"},{"llr":250.506,"date":"","count":565,"signal":"Thrombocytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 565 times (LLR=251)"},{"llr":246.986,"date":"","count":205,"signal":"Cardiogenic shock","source":"DrugCentral FAERS","actionTaken":"Reported 205 times (LLR=247)"},{"llr":222.534,"date":"","count":199,"signal":"Toxic epidermal necrolysis","source":"DrugCentral FAERS","actionTaken":"Reported 199 times (LLR=223)"},{"llr":208.93,"date":"","count":259,"signal":"Ascites","source":"DrugCentral FAERS","actionTaken":"Reported 259 times (LLR=209)"},{"llr":201.398,"date":"","count":757,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 757 times (LLR=201)"},{"llr":192.625,"date":"","count":306,"signal":"Multiple organ dysfunction syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 306 times (LLR=193)"},{"llr":184.363,"date":"","count":510,"signal":"Sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 510 times (LLR=184)"}],"commonSideEffects":[{"effect":"Major Bleeding Reactions","drugRate":"2.6%","severity":"serious"},{"effect":"Postoperative Transfusions","drugRate":"12.1%","severity":"serious"},{"effect":"Wound Hematoma","drugRate":"5.5%","severity":"serious"},{"effect":"Injection Site Hematoma","drugRate":"10.1%","severity":"serious"},{"effect":"Hematuria","drugRate":"2.9%","severity":"serious"},{"effect":"Hemorrhage","drugRate":"reported","severity":"serious"},{"effect":"Hematoma at the injection site","drugRate":"reported","severity":"serious"},{"effect":"Pain at the injection site","drugRate":"reported","severity":"mild"},{"effect":"Transient elevation of transaminases","drugRate":"6%","severity":"mild"}],"specialPopulations":{"Pregnancy":"Available data from published literature and postmarketing reports have not reported clear association with FRAGMIN and adverse developmental outcomes. There are risks to the mother associated with untreated VTE in pregnancy, and potential for adverse effects on the preterm infant when FRAGMIN is used in pregnancy (see Clinical Considerations). In animal reproduction studies, there was no evidence of embryo-fetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses to times (rats) and times (rabbits) the human dose of 100 IU/kg dalteparin based on the body surface area (see Data). Because animal reproduction studies are not always predictive of human response, FRAGMIN should be used during pregnancy only if clearly needed.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.. Clinical Considerations. Disease-Associated Maternal and/or Embryo/Fetal RiskPublished data describe that women with previous history of VTE in pregnancy are at higher risk for recurrence during subsequent pregnancies compared to those with no risk factor for VTE (4.","Geriatric use":"Of the total number of patients in clinical studies of FRAGMIN, 5,516 patients were 65 years of age or older and 2,237 were 75 or older. No overall differences in effectiveness were observed between these subjects and younger subjects. Some studies suggest that the risk of bleeding increases with age. Postmarketing surveillance and literature reports have not revealed additional differences in the safety of FRAGMIN between elderly and younger patients. Give careful attention to the risk of bleeding in elderly patients.","Paediatric use":"The safety and effectiveness of FRAGMIN for the treatment of symptomatic venous thromboembolism (VTE) in patients have been established in pediatric patients aged month and older.Use of FRAGMIN for this indication is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate studies in pediatric patients aged month and older with symptomatic VTE [see Adverse Reactions (6.1), Clinical Studies (14.2)."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"allNames":"fragmin","offLabel":[],"synonyms":["tinzaparin","ardeparin sodium","dalteparin sodium","tinzaparin sodium","bemiparin","bemiparin sodium"],"timeline":[{"date":"1994-12-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pfizer Inc)"}],"brandName":"Fragmin","ecosystem":[{"indication":"Deep venous thrombosis","otherDrugs":[{"name":"enoxaparin sodium","slug":"enoxaparin-sodium","company":"Sanofi Aventis Us"},{"name":"fondaparinux","slug":"fondaparinux","company":"Mylan Ireland Ltd"},{"name":"heparin","slug":"heparin","company":"Organon Usa Inc"},{"name":"rivaroxaban","slug":"rivaroxaban","company":"Janssen Pharms"}],"globalPrevalence":null},{"indication":"Pulmonary embolism","otherDrugs":[{"name":"alteplase","slug":"alteplase","company":"Genentech"},{"name":"dabigatran etexilate","slug":"dabigatran-etexilate","company":"Boehringer Ingelheim"},{"name":"edoxaban","slug":"edoxaban","company":"Daiichi Sankyo"},{"name":"enoxaparin sodium","slug":"enoxaparin-sodium","company":"Sanofi Aventis Us"}],"globalPrevalence":null}],"mechanism":{"target":"Factor Xa and thrombin (via antithrombin III enhancement)","novelty":"Follow-on","modality":"Small Molecule","drugClass":"Low Molecular Weight Heparin","explanation":"Dalteparin is low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).","oneSentence":"Fragmin works by binding to and activating antithrombin, which inhibits the coagulation cascade.","technicalDetail":"Fragmin exerts its anticoagulant effect by binding to antithrombin, a serine protease inhibitor, which in turn inhibits the activity of thrombin and factor Xa, key enzymes in the coagulation cascade."},"commercial":{"launchDate":"1994","annualCostUS":"$4,800-$9,600/yr","_launchSource":"DrugCentral (FDA 1994-12-22, PFIZER INC)","currentRevenue":"$200M","peakSalesEstimate":"$1.2B"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4840","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BEMIPARIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BEMIPARIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:57:59.569158","biosimilars":[],"competitors":[{"name":"Lovenox","company":"Sanofi","advantage":"Low molecular weight heparin with similar mechanism; more predictable pharmacokinetics and once or twice daily dosing options"},{"name":"Innohep","company":"LEO Pharma","advantage":"Tinzaparin, a low molecular weight heparin alternative with longer half-life allowing once-daily dosing"},{"name":"Xarelto","company":"Janssen/Bayer","advantage":"Direct Factor Xa inhibitor; oral anticoagulant offering convenience over injectable heparins"},{"name":"Eliquis","company":"Bristol Myers Squibb/Pfizer","advantage":"Direct Factor Xa inhibitor; oral anticoagulant with twice-daily dosing and no monitoring required"},{"name":"Arixtra","company":"Aspen Pharmacare","advantage":"Fondaparinux, selective Factor Xa inhibitor with once-daily subcutaneous injection and predictable dosing"}],"genericName":"bemiparin","indications":{"approved":[{"name":"Deep venous thrombosis","source":"DrugCentral","snomedId":128053003,"regulator":"FDA"},{"name":"Pulmonary embolism","source":"DrugCentral","snomedId":59282003,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"heparin","brandName":"heparin","genericName":"heparin","approvalYear":"1939","relationship":"same-class"},{"drugId":"enoxaparin-sodium","brandName":"enoxaparin sodium","genericName":"enoxaparin sodium","approvalYear":"1993","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07494877","phase":"","title":"Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility","status":"RECRUITING","sponsor":"Tang-Du Hospital","startDate":"2025-09-01","conditions":"Infertility","enrollment":300},{"nctId":"NCT07140211","phase":"PHASE3","title":"Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis","status":"RECRUITING","sponsor":"Marc Blondon","startDate":"2025-10-15","conditions":"Venous Thromboembolism (VTE), Postpartum","enrollment":9200},{"nctId":"NCT05848713","phase":"PHASE3","title":"AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia","status":"RECRUITING","sponsor":"University of Manitoba","startDate":"2023-10-10","conditions":"Community-acquired Pneumonia","enrollment":4000},{"nctId":"NCT07124819","phase":"PHASE3","title":"Dimolegin® (60 mg) Given Once Daily in Patients 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