What are the risks or side effects of using tranexamic acid (TXA)?

From the Guidelines

Tranexamic acid is generally safe when used as directed, but it can cause side effects and carries certain risks, including an increased risk of seizures when given in high doses, as reported in studies such as 1. The most common side effects of tranexamic acid include nausea, vomiting, diarrhea, and headaches. More serious but less common risks include blood clots, allergic reactions, vision changes, and seizures. People with a history of blood clots, certain kidney problems, or those taking hormonal contraceptives may face higher risks when using this medication. According to the CRASH-2 trial, a large-scale study published in the context of 2, tranexamic acid has been shown to reduce the risk of death due to bleeding in trauma patients, with no significant increase in adverse events, including thrombosis. However, the study also notes that the risk of precipitated thrombosis with the use of lysine analogues like tranexamic acid has been a theoretical concern. The typical dose of tranexamic acid for adults is a loading dose of 1 g infused over 10 minutes, followed by an intravenous infusion of 1 g over 8 hours, as recommended in 2. It's essential to use the medication exactly as prescribed and report any unusual symptoms to your healthcare provider immediately, especially severe headaches, vision changes, or signs of blood clots like leg pain, swelling, or breathing difficulties. In the context of trauma patients, the benefits of tranexamic acid in reducing mortality and morbidity due to bleeding outweigh the potential risks, as supported by studies such as 2 and 1. Therefore, tranexamic acid should be used judiciously, following established guidelines and under the supervision of a healthcare provider, to minimize the risk of adverse effects while maximizing its benefits in reducing bleeding-related complications. Key considerations for the use of tranexamic acid include:

• Administering the medication as early as possible to the trauma patient who is bleeding or at risk of significant hemorrhage
• Using the recommended dose and administration schedule
• Monitoring patients for signs of adverse effects, including seizures, blood clots, and allergic reactions
• Avoiding the use of tranexamic acid in patients with a history of blood clots, certain kidney problems, or those taking hormonal contraceptives, unless the benefits outweigh the risks.

From the FDA Drug Label

5. 1 Thromboembolic Risk

Tranexamic acid 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 Avoid concomitant use of Tranexamic acid and medical products that are pro-thrombotic, as the risk of thrombosis may be increased.

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

6. 3 Seizures Tranexamic acid may cause seizures, including focal and generalized seizures.

7. 4 Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid.

8. 5 Visual Disturbances Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid

9. 6 Dizziness Tranexamic acid may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect.

The risks or side effects when using tranexamic acid include:

• Thromboembolic risk: increased risk of thromboembolic events, such as venous and arterial thrombosis or thromboembolism
• Seizures: may cause seizures, including focal and generalized seizures
• Hypersensitivity reactions: cases of hypersensitivity reactions, including anaphylactic reactions
• Visual disturbances: potential risk of retinal degeneration, although not seen in humans
• Dizziness: may cause dizziness, and concomitant use of other drugs that may also cause dizziness may worsen this effect 3

From the Research

Risks and Side Effects of Tranexamic Acid

• The use of tranexamic acid has been associated with an increased risk of seizures and unexplained increased mortality when given more than three hours after traumatic bleeding 4.
• There is a risk of thromboembolic events, although the evidence is uncertain 5, 4, 6.
• Mild side effects such as nausea, vomiting, and dizziness are more common with the use of tranexamic acid 6.
• The effect of tranexamic acid on maternal mortality, severe morbidity, and thromboembolic events is uncertain 4, 6.
• There is insufficient evidence to draw conclusions about serious adverse events, including maternal death, thromboembolic events, hysterectomy, or seizures 4.

Specific Risks and Side Effects in Different Populations

• In women with post-partum haemorrhage, tranexamic acid reduces deaths due to bleeding with no increase in thromboembolic events 5.
• In women undergoing vaginal birth, prophylactic tranexamic acid makes little to no difference to blood loss ≥ 500 mL and likely makes little to no difference to blood loss ≥ 1000 mL or the risk of severe morbidity 4.
• In women undergoing revision total hip arthroplasty, intravenous tranexamic acid significantly reduces transfusion rates with no significant difference in rates of venous thromboembolic events 7.