Drugs
Information on Dabigatran Etexilate Mesylate (marketed as Pradaxa)
Pradaxa is in a class of anticoagulant (or blood thinner) medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
Pradaxa is used to help prevent strokes or serious blood clots in people who have non-valvular atrial fibrillation. Atrial fibrillation is a condition where the heart beats irregularly, thereby increasing the chance of clots forming in the body, which can lead to a stroke.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Related Information
FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
12/7/2011FDA Drug Safety Podcast for Healthcare Professionals: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
12/8/2011FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules
3/29/2011FDA Drug Safety Podcast for Healthcare Professionals: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules
Contact FDA
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
