Side effects of dabigatran
Even though dabigatran has been tested in clinical trials, it is a fairly new medicine and its full range of side effects is still being understood.
See your doctor straight away if you have any changes in your health or unusual symptoms after starting dabigatran.
Like all anticoagulants, bleeding is one of dabigatran’s side effects and it can sometimes be life threatening.
Bleeding seems as likely to occur with dabigatran as it is with warfarin. However, unlike warfarin there is currently no specific antidote for dabigatran to stop bleeding. So if you do have a serious bleed while you are taking dabigatran, it may take longer to treat.
Unlike warfarin, there is also currently no equivalent of the INR blood test to monitor dabigatran’s effect on blood clotting, or to inform any dose changes.
It is important to know the signs and symptoms of bleeding. Some signs of bleeding may not be obvious, particularly internal bleeding, so it’s important to know what these are.
If you are taking dabigatran because you’ve had knee or hip replacement surgery, you may find that some blood seeps through the dressing after your operation. Some seepage is normal, but if you think that the bleeding is excessive, speak to your doctor about it.
Ask your doctor which signs of bleeding you should be aware of and when to seek urgent medical assistance.
Signs and symptoms of bleeding
Some signs and symptoms of bleeding include:
- bruising that occurs easily or takes longer than normal to heal
- heavier than usual menstrual periods
- red or dark brown urine
- red or black bowel motions
- nosebleeds — particularly when they are frequent or take more than ten minutes to stop
- trouble breathing or swallowing
- coughing up blood
- bleeding from cuts, wounds and scrapes that takes too long to stop
- dark or blood-stained vomit
- severe headache or dizziness
- unexplained pain, swelling or discomfort.
A serious fall or injury may result in internal bleeding that is not obvious. Report any injuries to your doctor — including falls, cuts and scratches, bruising and accidents — even when you don’t notice any bleeding.
If you are not sure if you need urgent treatment, call healthdirect Australia on 1800 022 222, and speak to a registered nurse who can help you decide.
A common — but less serious — side effect of dabigatran is indigestion (dyspepsia). Speak to your health professional about ways to manage indigestion if it affects you. For example, swallowing dabigatran with water during a meal may help. Find out more about how to take dabigatran.
For a full list of possible side effects, see the dabigatran (Pradaxa) consumer medicine information (CMI) that is available on this website or from your pharmacist. Keep the CMI to refer to later if you need to. You can also ask your doctor about the possible side effects of dabigatran before you take it.
Who can I ask about side effects?
If you're concerned that you or someone in your care may have had side effects related to a medicine, seek medical advice. People with questions about their medicines or seeking general information about side effects can also call the NPS Medicines Line on 1300 633 424 (Monday–Friday, 9am–5pm AEST). Your call will be answered by healthdirect Australia (except Queensland and Victoria).
To report possible side effects call the Adverse Medicine Events (AME) Line on 1300 134 237 from anywhere in Australia (Monday–Friday, 9am–5pm AEST).
Find out more about:
- Rossi S, ed. eAMH [online]. Australian Medicines Handbook, January 2013. www.amh.net.au (accessed June 2013).
- Cardiovascular Expert Group. Therapeutic guidelines: cardiovascular. Therapeutic Guidelines Ltd; 2013. www.tg.org.au (accessed June 2013).
- NPS Medicine Update, April 2010. Dabigatran (Pradaxa) for preventing blood clots after hip or knee replacement surgery
- NPS Medicine Update, August 2011. Dabigatran (Pradaxa) for preventing stroke in people with atrial fibrillation