{ "query": "warfarin", "ingredient": "warfarin", "slug": "warfarin", "rxcui": "11289", "brands": [ "Jantoven" ], "names": [ "warfarin", "warfarin potassium", "warfarin sodium" ], "classes": [ { "id": "B01AA", "name": "Vitamin K antagonists" } ], "alternatives": [ "acenocoumarol", "dicumarol", "fluindione", "phenindione", "phenprocoumon", "tioclomarol" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 72 }, "boxed_warning": "WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions (7) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ]. WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Warfarin sodium can cause major or fatal bleeding. ( 5.1 ) Perform regular monitoring of INR in all treated patients. ( 2.1 ) Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. ( 7 ) Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. ( 17 )", "indications_and_usage": "Warfarin sodium tablets, USP are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Warfarin sodium is a vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 ) Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 ) Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 ) Limitations of Use Warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. ( 1 ) Limitations of Use Warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of ant...", "contraindications": "Warfarin sodium tablets, USP are contraindicated in: Pregnancy Warfarin sodium tablets, USP are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1) ]. Warfarin sodium can cause fetal harm when administered to a pregnant woman. Warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1) ]. Warfarin sodium tablets, USP are contraindicated in patients with: Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see Warnings and Precautions (5.8) ] Bleeding tendencies associated with: Active ulceration or overt bleeding of the gastrointestinal...", "warnings_and_cautions": "Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue warfarin sodium and consider alternative anticoagulants if necessary. ( 5.2 ) Calciphylaxis: Fatal and serious cases have occurred. Discontinue warfarin sodium and consider alternative anticoagulation therapy. ( 5.3 ) Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria. ( 5.4 ) Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. ( 5.5 ) Heparin-induced thrombocytopenia (HIT): Initial therapy with warfarin sodium in HIT has resulted in cases of amputation and death. Warfarin sodium may be considered after platelet count has normalized. ( 5.6 ) Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ( 5.7 ) 5.1 Hemorrhage Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age greater than or equal to 65, hi...", "warnings": "", "adverse_reactions": "The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: Hemorrhage [see Boxed Warning , Warnings and Precautions (5.1) , and Overdosage (10) ] Tissue Necrosis [see Warnings and Precautions (5.2) ] Calciphylaxis [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions (5.5) ] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions (5.6) ] Other Clinical Settings with Increased Risks [see Warnings and Precautions (5.8) ] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) Vascular disorders: vasculitis Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine. Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating Skin disorders: rash, dermatitis (including bullous eruptions), pruritu...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Dosage and Administration, Renal Impairment ( 2.5 ) 5/2017 Warnings and Precautions, Calciphylaxis ( 5.3 ) 9/2016 Warnings and Precautions, Acute kidney injury ( 5.4 ) 5/2017", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instructions for Patients Advise patients to: Strictly adhere to the prescribed dosage schedule [see Dosage and Administration (2.1) ]. If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration (2.6) ]. Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage and Administration (2.1) ]. Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days [see Clinical Pharmacology (12.2) ]. Avoid any activity or sport that may result in traumatic injury [see Use in Specific Populations (8.4) ]. And to tell their physician if they fall often as this may increase their risk for complications. Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables [see Drug Interactions (7.5) ]. Contact their physicia...", "spl_medguide": "MEDICATION GUIDE Warfarin (war' far in) Sodium Tablets, USP What is the most important information I should know about warfarin sodium tablets? Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium is a blood thinner medicine that lowers the chance of blood clots forming in your body. You may have a higher risk of bleeding if you take warfarin sodium and: are 65 years of age or older have a history of stomach or intestinal bleeding have high blood pressure (hypertension) have a history of stroke, or \"mini-stroke\" (transient ischemic attack or TIA) have serious heart disease have a low blood count or cancer have had trauma, such as an accident or surgery have kidney problems take other medicines that increase your risk of bleeding, including: a medicine that contains heparin other medicines to prevent or treat blood clots nonsteroidal anti-inflammatory drugs (NSAIDs) take warfarin sodium for a long time. Warfarin sodium is the active ingredient in warfarin sodium tablets, USP. Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed ...", "clinical_studies": "14.1 Atrial Fibrillation In five prospective, randomized, controlled clinical trials involving 3711 patients with non-rheumatic AF, warfarin significantly reduced the risk of systemic thromboembolism including stroke (see Table 4 ). The risk reduction ranged from 60% to 86% in all except one trial (CAFA: 45%), which was stopped early due to published positive results from two of these trials. The incidence of major bleeding in these trials ranged from 0.6% to 2.7% (see Table 4 ). Table 4: Clinical Studies of Warfarin in Non-Rheumatic AF Patients All study results of warfarin vs. control are based on intention-to-treat analysis and include ischemic stroke and systemic thromboembolism, excluding hemorrhagic stroke and transient ischemic attacks. N Thromboembolism % Major Bleeding Study Warfarin-Treated Patients Control Patients PT Ratio INR % Risk Reduction p -value Warfarin-Treated Patients Control Patients AFASAK 335 336 1.5-2.0 2.8-4.2 60 0.027 0.6 0.0 SPAF 210 211 1.3-1.8 2.0-4.5 67 0.01 1.9 1.9 BAATAF 212 208 1.2-1.5 1.5-2.7 86 <0.05 0.9 0.5 CAFA 187 191 1.3-1.6 2.0-3.0 45 0.25 2.7 0.5 SPINAF 260 265 1.2-1.5 1.4-2.8 79 0.001 2.3 1.5 Trials in patients with both AF and mitral ste...", "brand_name": "Warfarin Sodium", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "ANDA040301", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20210729", "set_id": "2c8f47c6-a180-4ad8-b962-04069d2270cb", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 138205, "serious": 105878, "death": 16527, "hospitalization": 63304, "primary_suspect": 137422, "top_reactions": [ [ "Dyspnoea", 10126 ], [ "International Normalised Ratio Increased", 7895 ], [ "Fatigue", 7371 ], [ "Diarrhoea", 7184 ], [ "Nausea", 6671 ], [ "Headache", 6174 ], [ "Death", 5938 ], [ "Drug Ineffective", 5598 ], [ "Drug Interaction", 5573 ], [ "Fall", 5511 ], [ "Dizziness", 5472 ], [ "Off Label Use", 5310 ], [ "Pneumonia", 4792 ], [ "Asthenia", 4789 ], [ "Malaise", 4540 ] ], "by_year": { "2019": 14119, "2020": 11861, "2021": 8118, "2022": 5653, "2023": 4708, "2024": 4105, "2025": 3461, "2026": 1479 }, "by_year_primary": { "2019": 14087, "2020": 11839, "2021": 8047, "2022": 5508, "2023": 4576, "2024": 3951, "2025": 3325, "2026": 1419 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "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" }, { "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" }, { "class": "Class III", "date": "20140825", "reason": "Failed Content Uniformity Specifications.", "firm": "Taro Pharmaceuticals U.S.A., Inc.", "status": "Terminated" } ], "recall_total": 3, "drugsfda": { "applications": 21, "nda": 3, "anda": 10, "first_approval": "19540608", "rems": false, "rems_last": "19750303", "labeling_supplements": 39, "labeling_recent": 0, "sponsors": [ "ABBOTT", "AIPING PHARM INC", "AMNEAL PHARMS", "AUROBINDO PHARMA USA", "BARR", "BRISTOL MYERS SQUIBB", "CHARTWELL RX", "INVAGEN PHARMS" ], "unapproved": false, "first_approval_fmt": "06/08/1954" }, "trials": { "total": 789, "completed": 495, "terminated": 75, "with_results": 153, "industry": 343, "phase3": 118, "results_share": 0.3090909090909091, "terminated_share": 0.09505703422053231 }, "pubmed": { "rct": 804, "meta": 312, "recent_rct": 65, "cochrane": [ { "pmid": "29105079", "title": "Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease", "year": "2017" }, { "pmid": "26822633", "title": "Warfarin initiation nomograms for venous thromboembolism", "year": "2016" }, { "pmid": "24832594", "title": "Vitamin K for improved anticoagulation control in patients receiving warfarin", "year": "2014" }, { "pmid": "23839808", "title": "Warfarin initiation nomograms for venous thromboembolism", "year": "2013" }, { "pmid": "23235665", "title": "Optimal loading dose of warfarin for the initiation of oral anticoagulation", "year": "2012" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "warfarin", "Jantoven" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 5034389, "beneficiaries": 936967, "spend": 46887356.21, "by_brand": [ { "brand": "Warfarin Sodium", "claims": 4665402, "per_claim": 9.3719913096, "is_generic": true }, { "brand": "Jantoven", "claims": 368987, "per_claim": 8.5727931065, "is_generic": false } ], "per_claim": 9.313415433332626 }, "mdl": [], "dsc": [ { "date": "20140513", "title": "FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm396470.htm", "kind": "drug", "matched": "warfarin" } ], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "warfarin", "matched": "warfarin", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 8695, "fills": 5034389, "per_million": 1727.1212057709486, "ratio": 0.6237459540053685, "median": 2768.949753790441 }, "scores": { "safety": { "score": 62, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-8)", "1,727 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site", "Death share in reports is near or below the FAERS average (1.3x)" ], "weight": 0.35 }, "evidence": { "score": 82, "letter": "B", "why": [ "804 randomized trials and 312 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "5 independent Cochrane review(s) exist", "Only 31% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 92, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 10 generic makers (-3)", "Label lists recent major changes to warnings or indications (-5)" ], "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 (10 applications)", "6 same-class alternatives exist" ], "weight": 0.1 } }, "total": 81, "grade": "B", "questions": [ "In 2014 the FDA issued a safety communication about this drug (FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding). Does that risk apply to me?", "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, international normalised ratio increased, fatigue, diarrhoea. How would we recognize and handle those?", "Why this one over acenocoumarol, dicumarol, fluindione? 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.)" ] }