Tranexamic Acid
Amino Acids
- Drug class
- Amino Acids
- Availability
- Prescription only
- Routes
- Intravenous, Oral
- Markets covered
- 3
- Products on record
- 59
- FDA reports (12 mo)
- 790
Overview
Plain-language summary, compiled from the cited regulatory records
Tranexamic acid is an antifibrinolytic agent belonging to the drug class of amino acids [1]. It is approved for use in patients with hemophilia to reduce or prevent hemorrhage and decrease the need for replacement therapy during and after tooth extraction [1]. This short-term treatment is typically administered for 2 to 8 days [1].
Tranexamic acid is available under various brand names [1]. In the past 12 months, there have been 790 adverse event reports associated with tranexamic acid [2]. The most frequently reported adverse events include reports of the drug being ineffective, off-label use, nausea, hypotension, and generalized tonic-clonic seizures [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 32 | May 22, 2026 |
| CA Canada | Health Canada | 20 | March 5, 2026 |
| US United States | FDA | 7 | January 7, 2026 |
GBUnited Kingdom· MHRA
32 products
Uses
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. • Local fibrinolysis occurs in the following conditions: Prostatectomy Menorrhagia Epistaxis Conisation of the cervix Traumatic hyphaema Management of dental extraction in haemophiliacs • Hereditary angioneurotic oedema
How to take
CACanada· Health Canada
20 products
Uses
1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of tranexamic acid in pediatric patients has been established for use in hereditary angioneurotic oedema and increased local fibrinolysis when the diagnosis is indicative of hyperfibrinolysis.
Specific data is available for surgical patients undergoing cardiac and orthopedic surgeries. Therefore, Health Canada has authorized Tranexamic Acid Tablets in these indications for pediatric use. For menorrhagia (hypermenorrhea), limited data are available to Health Canada.
Clinical experience with tranexamic acid in menorrhagic (hypermenorrhea) children under 18 years of age is not available. Therefore, Health Canada has not authorized Tranexamic Acid Tablets for this indication for pediatric use. 2 Geriatrics Clinical studies of tranexamic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
USUnited States· FDA
7 products
Uses
1 INDICATIONS AND USAGE 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.
( 1 )
How to take
Drug interactions
Known interactions involving Tranexamic Acid. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL142510026 · revised July 4, 2025
- [2]Health Canada (DPD) · 02401231 · revised March 22, 2025
- [3]FDA DailyMed · 00630e54-0e84-46… · revised March 15, 2024 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.