What are the side effects of Tranexamic acid (TXA)?

Side Effects of Tranexamic Acid (TXA)

Tranexamic acid (TXA) can cause thromboembolic events, seizures, hypersensitivity reactions, visual disturbances, and dizziness as its most serious side effects, though it is generally well-tolerated with mild gastrointestinal side effects being most common. 1

Common Side Effects

• Gastrointestinal effects:

  • Nausea
  • Vomiting
  • Diarrhea 1

• Other common mild effects:

  • Dizziness 1
  • Allergic dermatitis 2
  • Giddiness 2
  • Hypotension 2, 1

Serious Adverse Effects

1. Thromboembolic Risk

• TXA is contraindicated in patients with active intravascular clotting 1
• Venous and arterial thrombosis or thromboembolism has been reported 1
• Increased risk when used concomitantly with pro-thrombotic medications (Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, hormonal contraceptives) 1

2. Neurological Effects

• Seizures: Both focal and generalized seizures can occur 1

  • Higher risk with:
    • Higher doses (particularly in cardiac surgery)
    • Renal dysfunction
    • History of seizures
    • Inadvertent neuraxial administration 1
  • EEG monitoring should be considered for high-risk patients 1

• Dizziness: May impair ability to drive or operate machinery 1

3. Hypersensitivity Reactions

• Anaphylactic reactions have been reported 1
• TXA is contraindicated in patients with history of hypersensitivity to the drug 1

4. Visual Disturbances

• Retinal degeneration observed in animal studies at high doses 1
• Patients on long-term therapy (>3 months) should consider regular ophthalmological monitoring 1

5. Medication Error Risks

• TXA is for intravenous use only 1
• Serious adverse reactions including seizures and cardiac arrhythmias have occurred with inadvertent intrathecal administration 1

Overdose Symptoms

• Gastrointestinal symptoms (nausea, vomiting, diarrhea)
• Orthostatic hypotension
• Thromboembolic events
• Neurological symptoms (visual impairment, convulsions, headache, mental status changes)
• Myoclonus
• Rash 1

Special Considerations

Renal Impairment

• Dose adjustment required as TXA is primarily excreted unchanged by the kidneys 3
• Increased risk of complications (neurotoxicity, ocular toxicity) in patients with renal dysfunction 3

Contraindications

• Active intravascular clotting
• Subarachnoid hemorrhage
• Severe hypersensitivity to TXA or its ingredients 2, 1
• Use with caution in patients with massive hematuria due to risk of ureteric obstruction 2

Safety Profile Context

Despite these potential side effects, clinical evidence suggests TXA is generally well-tolerated when used appropriately:

• Most adverse reactions in clinical trials are considered mild or moderate 4
• Severe events are rare in clinical trials 4
• Multiple studies have shown TXA to be safe in various surgical procedures 4, 5
• Systematic reviews have not demonstrated increased risk of thrombosis with proper use 2, 5

When administering TXA, healthcare providers should carefully weigh the benefits of reduced bleeding against the potential risks, particularly in patients with pre-existing conditions that may increase susceptibility to adverse effects.