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Tranexamic acid

AEMPS

Antifibrinolytics, amino acids

ATC code: B02AA02

Brand names: Cyklokapron, Lysteda

Updated · Methodology

Indications

A

Heavy menstrual bleeding

First line

Per NG88 and 2024, tranexamic acid is first-line pharmacotherapy for heavy menstrual bleeding without organic pathology. Oral 1 g three to four times daily during the first 3–5 days of menses. Reduces menstrual blood loss by 40–50 %. Effect only during dosing – does not regulate cycles or provide contraception.

Sources

  1. Cochrane Database of Systematic Reviews: Antifibrinolytics for heavy menstrual bleeding (2018)
  2. NICE: Heavy menstrual bleeding: assessment and management (NG88) (2018)
  3. Cochrane Database of Systematic Reviews: Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis (2022)

ICD-10: N92.0 · ICD-11: GA20.50

A

Postpartum hemorrhage

First line

First-line for postpartum hemorrhage per 2022 and FIGO 2018. The WOMAN trial (Lancet 2017, over 20,000 patients) showed a 19 % reduction in death from bleeding when given within 3 hours of birth. Dose 1 g IV over 10 minutes, repeat after 30 minutes if bleeding persists. WHO recommends mandatory availability in maternity facilities.

Sources

  1. Lancet: Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. (2017)
  2. WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhag: WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage (2017) (2017)
  3. Cochrane Database Syst Rev: Tranexamic acid for preventing postpartum haemorrhage after vaginal birth. (2025)

ICD-10: O72 · ICD-11: JA43

A

Trauma-related bleeding

First line

First-line in major trauma with active bleeding per CRASH-2 (Lancet 2010, over 20,000 patients): death due to bleeding fell by about 15 % (RR 0.85). The effect is time-dependent: benefit is greatest within the first hour and is neutral or harmful after 3 hours. Dose 1 g IV over 10 minutes, then 1 g over 8 hours.

Sources

  1. The Lancet: Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial (2010)
  2. The Lancet: The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial (2011)
  3. Cochrane Database of Systematic Reviews: Antifibrinolytic drugs for acute traumatic injury (2015)

ICD-10: T79.2

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Common cold

Not recommended

Tranexamic acid in viral URI and sore throat is not mentioned in international guidelines. Common Russian use of nebulized tranexamic acid in pediatric stenotic laryngotracheitis is not supported by evidence – Cochrane reviews do not confirm efficacy. Croup standard care: nebulized epinephrine and systemic corticosteroids (dexamethasone, budesonide).

Sources

  1. J Gen Fam Med: Tranexamic Acid for Acute Upper Respiratory Tract Infection-Associated Sore Throat Pain: A Randomized Controlled Trial. (2026)
  2. Cochrane Database Syst Rev: Glucocorticoids for croup in children. (2018)
  3. Cochrane Database Syst Rev: Nebulized epinephrine for croup in children. (2013)

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Competitive plasminogen activation inhibitor at fibrin lysine sites. Suppresses fibrinolysis, stabilizes formed clots, and reduces blood loss. Does not activate coagulation — does not raise pathological thrombosis risk in patients without comorbidities. Short half-life (2 hours); effect develops 1–2 hours after IV administration, slightly later after oral.

Safety

Contraindications

  • Active thromboembolism (PE, DVT, stroke)
  • Personal history of venous or arterial thrombosis
  • Thrombophilic states
  • Subarachnoid hemorrhage
  • Severe renal impairment
  • Hypersensitivity
  • Disseminated intravascular coagulation (without concomitant treatment)

Serious adverse effects

  • Venous or arterial thromboembolism in at-risk patients
  • Seizures (especially with high-dose IV in cardiac surgery)
  • Visual disturbances (color vision changes) — rare
  • Hypersensitivity up to anaphylaxis (very rare)

Common adverse effects

  • Nausea, diarrhea
  • Headache
  • Abdominal pain
  • Menstrual changes in some patients

Pregnancy: can you take Tranexamic acid?

Justified in postpartum hemorrhage and third-trimester life-threatening bleeding. Per WOMAN-2, TXA may be considered individually for patients at risk of major intrapartum blood loss.

Breastfeeding: can you take Tranexamic acid?

Transfers into milk in minimal amounts. Compatible with breastfeeding per LactMed.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

In postpartum hemorrhage and trauma — IV as early as possible, ideally within 3 hours of bleeding onset. After 3 hours efficacy declines sharply. In menorrhagia — oral 1 g three to four times daily for 3–5 days of menses, max 4 g daily. Reduce dose in renal impairment.

Common myths

Myth: 'tranexamic acid stops any bleeding'. Fact: the bleeding-stopping effect is robustly shown in postpartum, traumatic, and menstrual bleeding. In other settings (epistaxis, GI bleeding) data are limited or absent; baseline care depends on cause.

Myth: 'tranexamic acid is dangerous from thrombosis'. Fact: in patients without thrombophilia or active venous disease, it is safe. Contraindicated in active or recent thromboembolism.

Myth: 'tranexamic acid is needed for URI'. Fact: international guidelines do not support use in URI, laryngitis, or sore throat. This is a local Russian practice without an evidence base.
Label mentions1 mention

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Moderateanticonceptivos hormonalesclass named in the label
    «El ácido tranexámico debe administrarse con precaución en las pacientes que toman anticonceptivos orales, debido al aumento del riesgo de trombosis.»

    AEMPS, section 4.4 · Open on CIMA

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Frequently asked

What is Tranexamic acid used for?

Tranexamic acid is evaluated for the following indications with varying evidence strength: Heavy menstrual bleeding (evidence tier A), Trauma-related bleeding (evidence tier A), Postpartum hemorrhage (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Tranexamic acid?

Common side effects of Tranexamic acid (≥ 1 in 100): Nausea, diarrhea, Headache, Abdominal pain, Menstrual changes in some patients. See the Safety section for uncommon and serious reactions.

Is Tranexamic acid safe during pregnancy?

Justified in postpartum hemorrhage and third-trimester life-threatening bleeding. Per WOMAN-2, TXA may be considered individually for patients at risk of major intrapartum blood loss.

Is Tranexamic acid compatible with breastfeeding?

Transfers into milk in minimal amounts. Compatible with breastfeeding per LactMed.

Who should not take Tranexamic acid?

Tranexamic acid is contraindicated in: Active thromboembolism (PE, DVT, stroke); Personal history of venous or arterial thrombosis; Thrombophilic states; Subarachnoid hemorrhage; Severe renal impairment. Full list in the Safety section.

tranexamic acid stops any bleeding

the bleeding-stopping effect is robustly shown in postpartum, traumatic, and menstrual bleeding. In other settings (epistaxis, GI bleeding) data are limited or absent; baseline care depends on cause.

tranexamic acid is dangerous from thrombosis

in patients without thrombophilia or active venous disease, it is safe. Contraindicated in active or recent thromboembolism.

tranexamic acid is needed for URI

international guidelines do not support use in URI, laryngitis, or sore throat. This is a local Russian practice without an evidence base.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Eltrombopag, Menaquinone (vitamin K2), Menaquinone-7, Phytomenadione