Tranexamic Acid

Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure.

• Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

• Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients.contraindicated

Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1 ) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions ( 5.1 )]. Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. Discard any unused portion. The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. ( 5.1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY. ( 5.2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. ( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. ( 5.6 ) 5.1 Thromboembolic Risk Tranexamic acid injection is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid injection. Avoid concomitant use of tranexamic acid injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.3 )] . 5.2 Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid injection is for intravenous use only. Serious adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally instead of intravenously.

The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Visual Disturbances [see Warnings and Precautions ( 5.5 )] Dizziness [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia.

8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data ) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Distribution The initial volume of distribution is about 9 to 12 liters. The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen.

Cases of overdosage of tranexamic acid injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash.

• Dec 30, 1986NDANDA019281Pfizer
• Nov 13, 2009NDANDA022430Amring Pharms
• Aug 10, 2011ANDAANDA201885Am Regent
• Nov 3, 2011ANDAANDA091657Mylan Institutional
• Dec 27, 2012ANDAANDA202093Actavis Labs Fl Inc
• Jun 14, 2013ANDAANDA201580Xgen Pharms
• Feb 11, 2014ANDAANDA202436Heritage
• Apr 15, 2019NDANDA212020Exela Pharma

1. 1Drug Ineffective6277.3%
2. 2Off Label Use6217.2%
3. 3Pyrexia3514.1%
4. 4Nausea3363.9%
5. 5Diarrhoea3103.6%
6. 6Hypotension3043.5%
7. 7Vomiting3033.5%
8. 8Haemorrhage2863.3%
9. 9Dyspnoea2733.2%
10. 10Pneumonia2693.1%
11. 11Febrile Neutropenia2603.0%
12. 12Headache2282.6%
13. 13Anaemia2232.6%
14. 14Fatigue2212.6%
15. 15Anaphylactic Reaction2202.6%

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

• Exploring the mechanism of differential responses to combination therapy in melasma: pigmentary versus mixed pigmentary-vascular types-a clinical study based on interaction analysis.
  The Journal of dermatological treatment · 2026 · Li X, Nie L, Guo W, et al.
  PMID 42267621DOI 10.1080/09546634.2026.2680823
• Revision rate and postoperative volume development of chronic subdural hematomas after burr hole craniotomy in combination with tranexamic acid vs. surgery alone - a single-center propensity score-matched analysis.
  BMC neurology · 2026 · Scheer M, Witte H, Guenzerodt P, et al.
  PMID 42260407DOI 10.1186/s12883-026-05003-3
• Opportunities to expand delivery of prehospital tranexamic acid to bleeding trauma patients - findings from a prospective multicentre trauma study in the Western Cape Province, South Africa.
  South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde · 2026 · Abdullah N, Young J, Stassen W, et al.
  PMID 42246841DOI 10.7196/SAMJ.2026.v116i4.3787
• [Hemostatic efficacy of tranexamic acid combined with absorbable fluid hemostat in single-level transforaminal lumbar interbody fusion during the perioperative period].
  Zhongguo gu shang = China journal of orthopaedics and traumatology · 2026 · Li H, Tian Z, He C, et al.
  PMID 42229983DOI 10.12200/j.issn.1003-0034.20250035
• [Evaluation of the Efficacy and Tolerance of Tranexamic Acid Combined with Inoserp(TM) PAN-AFRICA Antivenom in the Treatment of Hemorrhagic Syndrome during Envenomation by Echis ocellatus in Benin].
  Medecine tropicale et sante internationale · 2026 · Larréché S, Sodjinou N, Tourita N, et al.
  PMID 42221451DOI 10.48327/mtsi.v6i1.2026.745
• Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery: A Systematic Review and Meta-Analysis.
  Journal of the College of Physicians and Surgeons--Pakistan : JCPSP · 2026 · Zhang X, Lin H, Xu H, et al.
  PMID 42219839DOI 10.29271/jcpsp.2026.06.789
• Functional Aspects of Fibrin Structure Alterations by Tranexamic Acid in the Inhibition of Fibrinolysis.
  Biomolecules · 2026 · Balog Virag K, Baráth B, Molnár K, et al.
  PMID 42194044DOI 10.3390/biom16050696
• Topical intra articular tranexamic acid reduces packed blood cell consumption in total joint arthroplasty.
  Acta ortopedica mexicana · 2026 · Fraind-Maya G, Nasrawy T, Kandel L, et al.
  PMID 42191388

The 10 most recently updated of 796 ClinicalTrials.gov registrations naming Tranexamic Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation
  Completed · Interventional · 18 enrolled · Revision Skincare
  NCT07644871updated 2026-06-12
• Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
  Not yet recruiting · Phase 4 · Interventional · 40 enrolled · NYU Langone Health
  NCT07644923updated 2026-06-12
• Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis
  Not yet recruiting · Phase 3 · Interventional · 170 enrolled · Assiut University
  NCT07641946updated 2026-06-11
• Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty
  Not yet recruiting · Phase 4 · Interventional · 80 enrolled · Hua Luo
  NCT07614087updated 2026-06-11
• COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
  Recruiting · Interventional · 570 enrolled · University Hospital, Bordeaux
  NCT06425614updated 2026-06-11
• Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
  Completed · Observational · 40 enrolled · Hôpital NOVO
  NCT03364569updated 2026-06-09
• EFFECT OF TRANEXAMIC ACID ON PERIOPERATIVE BLOOD LOSS IN REAMED INTRAMEDULLARY NAILING OF DIAPHYSEAL FEMORAL AND TIBIAL FRACTURES: A PROSPECTIVE COMPARATIVE STUDY
  Completed · Interventional · 54 enrolled · Kathmandu University School of Medical Sciences
  NCT07625709updated 2026-06-04
• Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
  Recruiting · Phase 2 · Interventional · 150 enrolled · University of California, San Francisco
  NCT05794321updated 2026-06-04
• The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
  Recruiting · Phase 3 · Interventional · 130 enrolled · Unity Health Toronto
  NCT05713630updated 2026-05-29
• Combined Tranexamic Acid Use in Total Hip Replacement Surgery
  Completed · Interventional · 58 enrolled · St. Anne's University Hospital Brno, Czech Republic
  NCT07610863updated 2026-05-28

Frequently asked questions

How does Tranexamic Acid work?

Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure.

What is Tranexamic Acid used for?

According to FDA labeling, Tranexamic Acid carries indications including: Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tranexamic Acid?

Tranexamic Acid is classified as Amino acids, Antifibrinolytic Agent, Plasmin Inhibitors, Decreased Fibrinolysis.

What are the brand names for Tranexamic Acid?

Tranexamic Acid is marketed under brand names including Cyklokapron, Lysteda.

What are the contraindications for Tranexamic Acid?

Tranexamic Acid labeling lists contraindications including: Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients.. Always consult the full prescribing information and a clinician.