Tranexamic acid Side Effects

Home › Medicine Side Effects › tranexamic acid

Answer the side-effect intent for tranexamic acid without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is tranexamic acid?

Tranexamic-Acid contains the active ingredient Tranexamic acid.

• Active ingredient — Tranexamic acid
• Registration number — 48/8.1/1085
• Registration holder — Pharmacorp (Pty) Ltd

It is approved for:

• The active substance is tranexamic acid. Each 5 ml of solution contains 500 mg of tranexamic acid
• The other ingredients are hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injection. What TRANEXAMIC ACID 100 mg/mL PHARMC looks like and contents of the pack TRANEXAMIC ACID 100 mg/mL PHARMC is a clear, colourless solution. It is packed as 5 ml in USP type I clear glass ampoule. Pack size: 1 or 5 ampoule(s) in an outer carton

Common side effects of tranexamic acid

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• nausea
• vomiting
• diarrhoea

Less frequent side effects

• allergic skin reactions
• thromboembolic events (e.g. formation of a blood clot)
• vision disturbances including impaired colour vision

Frequency unknown side effects

• malaise with hypotension (low blood pressure), with or without loss of consciousness, especially if the injection is given too quickly
• blood clots
• convulsions (fits)
• dizziness
• allergic reactions

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to tranexamic acid or any of the other ingredients of TRANEXAMIC ACID 100 mg/mL PHARMC (listed in section 6)
• If you have massive bleeding in the upper urinary tract (bladder and kidney area)
• If you currently have a disease leading to blood clots
• If you have colour vision disorder
• If you have inflammation of the wall of a vein with associated blood clotting (thrombophlebitis)
• If you have liver problems
• If you have bleeding into the space surrounding the brain
• If you have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot
• If you have kidney problems
• If you have a history of convulsions. If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before TRANEXAMIC ACID 100 mg/mL PHARMC is given to you

Use with care, and tell your doctor, if

• If you have had convulsions. Your doctor might use the lowest dose possible to avoid convulsions after your treatment with TRANEXAMIC ACID 100 mg/mL PHARMC
• If you are receiving TRANEXAMIC ACID 100 mg/mL PHARMC over a long period of time, you may have a higher risk to become colour blind. Your doctor might test your eyes regularly and based on the results decide to stop treatment
• If you have had blood in your urine, it may lead to urinary tract obstruction, that can cause kidney damage, kidney stones and infection
• If you have a risk of having blood clots and/or if you are receiving Factor IX Complex Concentrates or Anti-inhibitor Coagulant Concentrates. TRANEXAMIC ACID 100 mg/mL PHARMC may increase your risk of blood clotting
• If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation). Your doctor will decide if TRANEXAMIC ACID 100 mg/mL PHARMC is right for you
• If you have heavy periods/ severe menstrual bleeding (menorrhagia), your doctor might do some blood tests to make sure why you have menorrhagia before TRANEXAMIC ACID 100 mg/mL PHARMC is given to you

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving TRANEXAMIC ACID 100 mg/mL PHARMC
• Women that can become pregnant have to use effective contraception during TRANEXAMIC ACID 100 mg/mL PHARMC treatment
• Tranexamic acid as in TRANEXAMIC ACID 100 mg/mL PHARMC passes into breastmilk
• Therefore, you should not use TRANEXAMIC ACID 100 mg/mL PHARMC when you are breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Other medicines that help blood to clot called antifibrinolytic medicines
• Medicines that prevent blood clotting, called thrombolytic medicines
• Oral contraceptives

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• minoxidil side effects

← Back to more medicine side effects.