{
 "query": "enoxaparin",
 "ingredient": "enoxaparin",
 "slug": "enoxaparin",
 "rxcui": "67108",
 "brands": [
  "Lovenox"
 ],
 "names": [
  "enoxaparin",
  "enoxaparin sodium"
 ],
 "classes": [
  {
   "id": "B01AB",
   "name": "Heparin group"
  }
 ],
 "alternatives": [
  "antithrombin iii",
  "bemiparin",
  "dalteparin",
  "danaparoid",
  "heparin",
  "nadroparin",
  "parnaparin",
  "reviparin",
  "tinzaparin"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 22,
   "INTRAVENOUS": 9
  },
  "boxed_warning": "WARNING: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of enoxaparin sodium and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) ...",
  "indications_and_usage": "Enoxaparin sodium 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\u2013Q-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 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 severely restricted mobil...",
  "contraindications": "Enoxaparin sodium 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 Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of enoxaparin sodium) [see Warnings and Precautions (5.8) ] 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 ) Hypersensitivity to benzyl alcohol (for multiple-dose formulation only) ( 4 )",
  "warnings_and_cautions": "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 as...",
  "warnings": "",
  "adverse_reactions": "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 Fresenius Kabi USA, LLC at 1-800-551-7176 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. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thrombo...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Instructions for Use). If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. Instruct the patient to seek immediate medical attention if any of these symptoms occur. Inform patients: of the instructions for injecting enoxaparin sodium if they continue enoxaparin sodium therapy after discharge from the hospital. that it may take them longer than usual to stop bleeding. that they may bruise and/or bleed more easily when they use enoxaparin sodium. that they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1 , 5.5) ] . that risks are associated with the use of benzyl alcohol, a preservative in enoxaparin sodium multiple-dose vials, in neonates, infants, and pregnant women. to tell their physicians and dentists they are taking enoxapar...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Prophylaxis of Deep Vein Thrombosis following Abdominal Surgery in Patients at Risk for Thromboembolic Complications Abdominal surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes or who have additional risk factors such as malignancy or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE). In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of 1116 patients were enrolled in the study, and 1115 patients were treated. Patients ranged in age from 32 to 97 years (mean age 67 years) with 52.7% men and 47.3% women. Patients were 98% Caucasian, 1.1% Black, 0.4% Asian and 0.4% others. Enoxaparin sodium 40 mg subcutaneously, administered once a day, beginning 2 hours prior to surgery and continuing for a maximum of 12 days after surgery, was comparable to heparin 5000 U every 8 hours subcutaneously in reducing the risk of DVT. The efficacy data are provided below (see Table 14 ). Table 14: Efficacy of Enoxaparin Sodium in the Prophylaxis of Deep Vein Thrombosis following A...",
  "brand_name": "Enoxaparin Sodium",
  "manufacturer": "Fresenius Kabi USA, LLC",
  "application_number": "NDA020164",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS",
   "INTRAVENOUS"
  ],
  "effective_time": "20260204",
  "set_id": "066f27ec-352c-4051-ba29-248e292690db",
  "has_boxed_warning": true,
  "boxed_labels": "22 of 22",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 72445,
  "serious": 63756,
  "death": 10303,
  "hospitalization": 38770,
  "primary_suspect": 72100,
  "top_reactions": [
   [
    "Off Label Use",
    4967
   ],
   [
    "Dyspnoea",
    3017
   ],
   [
    "Diarrhoea",
    2963
   ],
   [
    "Nausea",
    2927
   ],
   [
    "Acute Kidney Injury",
    2926
   ],
   [
    "Pyrexia",
    2807
   ],
   [
    "Fatigue",
    2592
   ],
   [
    "Anaemia",
    2551
   ],
   [
    "Vomiting",
    2303
   ],
   [
    "Pneumonia",
    2160
   ],
   [
    "Thrombocytopenia",
    2141
   ],
   [
    "Death",
    1951
   ],
   [
    "Drug Ineffective",
    1887
   ],
   [
    "Drug Interaction",
    1741
   ],
   [
    "Asthenia",
    1706
   ]
  ],
  "by_year": {
   "2019": 7292,
   "2020": 8565,
   "2021": 7102,
   "2022": 6415,
   "2023": 5340,
   "2024": 4695,
   "2025": 4397,
   "2026": 2028
  },
  "by_year_primary": {
   "2019": 7281,
   "2020": 8562,
   "2021": 7079,
   "2022": 6321,
   "2023": 5263,
   "2024": 4642,
   "2025": 4356,
   "2026": 1999
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250805",
   "reason": "Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL",
   "firm": "Cardinal Health Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 13,
  "nda": 2,
  "anda": 11,
  "first_approval": "19930329",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 32,
  "labeling_recent": 3,
  "sponsors": [
   "AMPHASTAR PHARM",
   "AMPHASTAR PHARMS INC",
   "BE PHARMS",
   "EMERGE BIOSCIENCE",
   "GLAND",
   "HEBEI CHANGSHAN",
   "SANDOZ",
   "SANDOZ INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/29/1993"
 },
 "trials": {
  "total": 496,
  "completed": 296,
  "terminated": 68,
  "with_results": 99,
  "industry": 177,
  "phase3": 139,
  "results_share": 0.3344594594594595,
  "terminated_share": 0.13709677419354838
 },
 "pubmed": {
  "rct": 417,
  "meta": 62,
  "recent_rct": 43,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "enoxaparin",
   "Lovenox"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 533899,
  "beneficiaries": 282953,
  "spend": 80080629.89999999,
  "by_brand": [
   {
    "brand": "Enoxaparin Sodium",
    "claims": 532949,
    "per_claim": 149.17759061,
    "is_generic": true
   },
   {
    "brand": "Lovenox",
    "claims": 950,
    "per_claim": 606.92858947,
    "is_generic": false
   }
  ],
  "per_claim": 149.99209569600242
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "enoxaparin",
  "matched": "enoxaparin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10997,
  "fills": 533899,
  "per_million": 20597.528746073694,
  "ratio": 7.438751359744809,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "20,598 FDA reports naming it as the suspect drug per million Medicare fills, 7.4x the median drug on this site (-15)",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "417 randomized trials and 62 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 33% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 11 generic makers (-3)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (11 applications)",
    "9 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, diarrhoea, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over antithrombin iii, bemiparin, dalteparin? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}