Enoxaparin

Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

• Enoxaparin sodium injection is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) Prophylaxis of ischemic complications of unstable angina and non−Q-wave myocardial infarction (MI) ( 1.3 ) Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1) ] in patients undergoing hip replacement surgery, during and following hospitalization in patients undergoing knee replacement surgery in medical patients who are at risk for thromboembolic complications due to sever…ICD-10: I20.9, I21.9, I26.99, I82.409

• Enoxaparin sodium injection is contraindicated in patients with: • Active major bleeding • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions (5.4) ] • Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/ anaphylactoid reactions) [see Adverse Reactions (6.2) ] • Known hypersensitivity to heparin or pork products Active major bleeding ( 4 ) History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies ( 4 ) Hypersensitivity to enoxaparin sodium ( 4 ) Hypersensitivity to heparin or pork products ( 4 )contraindicated

See full prescribing information for dosing and administration information. ( 2 ) 2.1 Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting enoxaparin sodium treatment, unless treatment is urgently needed. 2.2 Adult Dosage Abdominal Surgery The recommended dose of enoxaparin sodium is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications. The usual duration of administration is 7 to 10 days [see Clinical Studies (14.1) ]. Hip or Knee Replacement Surgery The recommended dose of enoxaparin sodium is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery. Administer the initial dose 12 to 24 hours after surgery, provided that hemostasis has been established. The usual duration of administration is 7 to 10 days [see Clinical Studies (14.2) ]. A dose of enoxaparin sodium of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks. Administer the initial dose 12 (±3) hours prior to surgery. Medical Patients during Acute Illness The recommended dose of enoxaparin sodium is 40 mg once a day administered by subcutaneous injection for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness. The usual duration of administration is 6 to 11 days [see Clinical Studies (14.3) ].

Increased risk of hemorrhage: Monitor for signs of bleeding ( 5.1 , 5.2 , 5.3 ) Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis ( 5.4 ) Thrombocytopenia: Monitor platelet count closely ( 5.5 ) Interchangeability with other heparins: Do not exchange with heparin or other LMWHs ( 5.6 ) Increased Risk of Thrombosis in Pregnant women with Mechanical Prosthetic Heart Valves: women and their fetuses may be at increased risk. Monitor more frequently and adjust dosage as needed. ( 5.7 ) 5.1 Increased Risk of Hemorrhage Cases of epidural or spinal hemorrhage and subsequent hematomas have been reported with the use of enoxaparin sodium and epidural or spinal anesthesia/analgesia or spinal puncture procedures, resulting in long-term or permanent paralysis. The risk of these events is higher with the use of postoperative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning, Adverse Reactions (6.2) and Drug Interactions (7) ] . To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin [see Clinical Pharmacology (12.3) ] .

The following serious adverse reactions are also discussed in other sections of the labeling: • Spinal/epidural hematomas [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Increased Risk of Hemorrhage [see Warnings and Precautions ( 5.1 )] • Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 15,918 patients were exposed to enoxaparin sodium.

Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min ( 2.3 , 8.7 ) Geriatric Patients: Monitor for increased risk of bleeding ( 8.5 ) Low-Weight Patients: Observe for signs of bleeding ( 8.8 ) 8.1 Pregnancy Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin sodium does not increase the risk of major developmental abnormalities [see Data]. Based on animal data, enoxaparin is not predicted to increase the risk of major developmental abnormalities [see Data]. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions.

Metabolism

Absorption Pharmacokinetic trials were conducted using the 100 mg/mL formulation. Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3 to 5 hours after subcutaneous injection of enoxaparin.

Accidental overdosage following administration of enoxaparin sodium may lead to hemorrhagic complications. Injected enoxaparin sodium may be largely neutralized by the slow intravenous injection of protamine sulfate (1% solution). The dose of protamine sulfate should be equal to the dose of enoxaparin sodium injected: 1 mg protamine sulfate should be administered to neutralize 1 mg enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of enoxaparin sodium may be administered if the aPTT measured 2 to 4 hours after the first infusion remains prolonged. If at least 12 hours have elapsed since the last enoxaparin sodium injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin.

• Mar 29, 1993NDANDA020164Sanofi Aventis Us
• Jul 23, 2010ANDAANDA077857Sandoz
• Sep 19, 2011ANDAANDA076684Amphastar Pharm
• Jun 23, 2014ANDAANDA076726Zydus Pharms
• Sep 28, 2018ANDAANDA078990Gland
• Mar 14, 2019ANDAANDA208600Amphastar Pharms Inc
• Nov 29, 2019ANDAANDA206834Emerge Bioscience
• Jun 14, 2022ANDAANDA214856Emerge Bioscience

1. 1Off Label Use2,4284.3%
2. 2Dyspnoea2,3984.2%
3. 3Nausea2,3824.2%
4. 4Diarrhoea2,2734.0%
5. 5Anaemia2,2083.9%
6. 6Thrombocytopenia2,0803.7%
7. 7Pyrexia2,0653.7%
8. 8Fatigue1,9913.5%
9. 9Vomiting1,8773.3%
10. 10Pulmonary Embolism1,7973.2%
11. 11Death1,7503.1%
12. 12Pneumonia1,6733.0%
13. 13Asthenia1,6182.9%
14. 14Acute Kidney Injury1,5842.8%
15. 15Fall1,5212.7%

Recent PubMed references pinned to Enoxaparin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Optimizing Venous Thromboembolism Prophylaxis in Burn Patients Using Enoxaparin Through PBPK Modeling.
  CPT: pharmacometrics & systems pharmacology · 2026 · Mim SR, Yellepeddi VK, Azeredo FJ, et al.
  PMID 42150550DOI 10.1002/psp4.70265
• Weight based dosing of prophylactic enoxaparin was not associated with reduced venous thromboembolism events following open reduction and internal fixation of acetabular fractures.
  European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2026 · Nian P, Meyer A, Said M, et al.
  PMID 42101694DOI 10.1007/s00590-026-04770-6
• Nimodipine and enoxaparin improve neurological outcomes and reduce cerebral edema by modulating glymphatic perivascular spaces in a rabbit model of subarachnoid hemorrhage.
  Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2026 · Çetinkaya K, Ünsal Y, Özateş MÖ, et al.
  PMID 42070675DOI 10.1016/j.jstrokecerebrovasdis.2026.108654
• Sustainable Spectrofluorimetric Sensing Platform for Enoxaparin Estimation: Compliance With Green Chemistry and Sustainable Development Goals.
  Luminescence : the journal of biological and chemical luminescence · 2026 · Megahed SM, Habib AA
  PMID 42055962DOI 10.1002/bio.70498
• Early pregravid correction of hemostasis assessed by novel biomarkers improves the outcomes of pregnancies in women with bad obstetric history.
  Clinical science (London, England : 1979) · 2026 · Safiullina SI, Evtugina NG, Peshkova AD, et al.
  PMID 42012486DOI 10.1042/CS20260246
• Venous thromboembolism in pelvic ring and acetabular fractures - A prospective cohort study.
  Injury · 2026 · Vogel C, Goebel A, Zimmermann E, et al.
  PMID 41997095DOI 10.1016/j.injury.2026.113268
• Long-term pediatric outcomes after first-trimester exposure to low-dose warfarin plus enoxaparin versus enoxaparin alone in pregnancies with mechanical heart valves: the KYBELE children study.
  BMC cardiovascular disorders · 2026 · Arici S, Yildirim AI, Keskin GY, et al.
  PMID 41957566DOI 10.1186/s12872-026-05837-2
• C3 as a sensitive biomarker of alveolocapillary barrier integrity in acute lung injury: Protective modulation by enoxaparin.
  Tissue & cell · 2026 · Mustafaoğlu A, Armağan İ, Şirin MC, et al.
  PMID 41875697DOI 10.1016/j.tice.2026.103458

The 10 most recently updated of 487 ClinicalTrials.gov registrations naming Enoxaparin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Emulation of the RECORD3 Trial Using Healthcare Claims Data
  Active not recruiting · Observational · 149,248 enrolled · Brigham and Women's Hospital
  NCT07599384updated 2026-06-11
• Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI
  Not yet recruiting · Phase 4 · Interventional · 240 enrolled · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  NCT07641231updated 2026-06-11
• Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
  Active not recruiting · Observational · 89,215 enrolled · Brigham and Women's Hospital
  NCT05083455updated 2026-06-11
• Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
  Recruiting · Phase 4 · Interventional · 2,400 enrolled · University Hospital, Brest
  NCT06845423updated 2026-06-10
• Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
  Recruiting · Phase 2 · Phase 3 · Interventional · 258 enrolled · Yale University
  NCT04924322updated 2026-06-08
• THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
  Recruiting · Phase 4 · Interventional · 3,175 enrolled · Imperial College London
  NCT05735639updated 2026-06-04
• A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
  Active not recruiting · Phase 1 · Interventional · 179 enrolled · AstraZeneca
  NCT07312851updated 2026-06-02
• Rivaroxaban in Pediatric Patients With DVT
  Completed · Phase 4 · Interventional · 60 enrolled · Ain Shams University
  NCT07618988updated 2026-06-01
• A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
  Completed · Phase 2 · Interventional · 179 enrolled · Regeneron Pharmaceuticals
  NCT06454630updated 2026-05-27
• Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
  Not yet recruiting · Phase 3 · Interventional · 802 enrolled · Johns Hopkins All Children's Hospital
  NCT06628778updated 2026-05-26

Frequently asked questions

How does Enoxaparin work?

Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

What is Enoxaparin used for?

According to FDA labeling, Enoxaparin carries indications including: Enoxaparin sodium injection is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) Prophylaxis of ischemic complications of unstable angina and non−Q-wave myocardial infarction (MI) ( 1.3 ) Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1) ] in patients undergoing hip replacement surgery, during and following hospitalization in patients undergoing knee replacement surgery in medical patients who are at risk for thromboembolic complications due to sever…. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Enoxaparin?

Enoxaparin is classified as Heparin group, Low Molecular Weight Heparin, Antithrombins, Enzyme Activators, Factor Xa Inhibitors, Serine Proteinase Inhibitors, Decreased Coagulation Factor Activity.

What are the brand names for Enoxaparin?

Enoxaparin is marketed under brand names including Lovenox.

What are the contraindications for Enoxaparin?

Enoxaparin labeling lists contraindications including: Enoxaparin sodium injection is contraindicated in patients with: • Active major bleeding • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions (5.4) ] • Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/ anaphylactoid reactions) [see Adverse Reactions (6.2) ] • Known hypersensitivity to heparin or pork products Active major bleeding ( 4 ) History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies ( 4 ) Hypersensitivity to enoxaparin sodium ( 4 ) Hypersensitivity to heparin or pork products ( 4 ). Always consult the full prescribing information and a clinician.