Your risk of bleeding with PRADAXA may be higher if you:
- are 75 years old or older
- have kidney problems
- have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
- take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
- have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)
Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:
- any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
- unusual or unexpected bruising
- coughing up or vomiting blood; or vomit that looks like coffee grounds
- pink or brown urine; red or black stools (looks like tar)
- unexpected pain, swelling, or joint pain
- headaches and feeling dizzy or weak
Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
- a thin tube called an epidural catheter is placed in your back to give you certain medicine
- you take NSAIDs or a medicine to prevent blood from clotting
- you have a history of difficult or repeated epidural or spinal punctures
- you have a history of problems with your spine or have had surgery on your spine.
If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with PRADAXA.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You and your doctor should decide if you will take PRADAXA or breastfeed.
Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines (prescription and over‑the‑counter), vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.
PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
CL-PX-100034 January 2019
Please see full Prescribing Information and Medication Guide.