Pradaxa Side Effects

WHAT IS PRADAXA?

Pradaxa (dabigatran etexilate mesylate) capsules are a blood-thinning medicine utilized to lessen the risk of blood clots and stroke in individuals with atrial fibrillation not caused by a heart valve problem.

Pradaxa Side Effects: IMPORTANT SAFETY INFO ABOUT PRADAXA

PRADAXA can cause bleeding that can be severe and at times lead to death. Do not take PRADAXA if you at present have abnormal bleeding or if one have ever had an allergic reaction to it.

Your risk of bleeding with PRADAXA may be higher if you:

??? are seventy-five years old or older

??? have kidney problems

??? have kidney problems & take ketoconazole tablets (Nizoral) or dronedarone (Multaq)

??? have intestine or stomach bleeding that is recent or keeps coming back or you have an ulcer in the stomach

??? take other drugs that increase the risk of bleeding, like aspirin products, or several non-steroidal anti-inflammatory drugs (NSAIDs) & blood thinners

Call your medical doctor or seek immediate health care if you have any of the following signs or symptoms of blood loss:

??? any severe, unexpected, or uncontrollable bleeding; or blood loss that lasts a long time

??? vomiting or coughing up blood; or vomit that appears like coffee grounds

??? brown or pink urine; black or red stools (looks similar to tar)

??? unexpected swelling, pain, or joint pain

??? unexpected or unusual bruising

??? feeling dizzy or weak and headaches

Side Effects of Pradaxa – for the Consumer

Pradaxa

All drugs may cause side effects, but a lot of people have no, or minor, side effects. Check with your consultant if any of these most general side effects persist or become troublesome when using Pradaxa:

Diarrhea; mild stomach pain or upset; heartburn; indigestion; nausea.

Seek health attention immediately if any of these SEVERE side effects take place when using

Pradaxa:

Severe allergic reactions (rash; hives; difficulty breathing; itching; joint pain, tightness in the chest; face, lips, or tongue; sided weakness; coughing up blood; weakness, swelling of the mouth, wheezing); fainting; bloody or black, tarry stools; severe or persistent sore throat or stomach pain; one- pink, brown, or dark urine; slurred speech; chest pain; confusion; dizziness, or unusual headaches; swelling, or discomfort; unusual bruising or bleeding (eg, excessive bleeding from cuts, repeated nosebleeds, oddly heavy vaginal or menstrual bleeding, unusual bleeding from gums); vision problems; vomit that looks like coffee or blood grounds.

This is not the entire list of all side effects that may happen. If you have questions about side effects, get in touch with your health care provider. Call your consultant for health advice about side effects. You can report side effects to FDA at this number 1-800-FDA-1088 . You may as well report side effects at this website:

Common Side Effects by Body System – for Healthcare Professionals

Hematologic

Hematologic side effects have included intraocular, intraspinal intracranial, or intramuscular with retroperitoneal bleeding, intraarticular bleeding, compartment syndrome, or pericardial bleeding. Intracranial haemorrhage included subarachnoid, intracerebral (hemorrhagic stroke), & subdural bleeds.

Gastrointestinal

GI side effects have included dyspepsia (including abdominal pain, abdominal discomfort, abdominal pain upper, and epigastric discomfort) and gastritis-like symptoms (including erosive gastritis, GERD, gastric haemorrhage, esophagitis, hemorrhagic erosive gastritis, hemorrhagic gastritis, and GI ulcer).

Hypersensitivity

Hypersensitivity side effects have included rash, allergic edema, urticaria, and pruritus, anaphylactic reaction, and worse anaphylactic shock.

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