Note: This document contains side effect information about tranexamic acid. Some dosage forms listed on this page may not apply to the brand name Lysteda.

Applies to tranexamic acid: oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Lysteda

Along with its needed effects, tranexamic acid (the active ingredient contained in Lysteda) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tranexamic acid:

More common

• Pale skin
• trouble breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Anxiety
• change in vision
• chest pain or tightness
• confusion
• cough
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• numbness of the hands
• pain, redness, or swelling in the arm or leg
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash, hives, or itching

Other side effects of Lysteda

Some side effects of tranexamic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain, discomfort, or tenderness
• chills or fever
• difficulty with moving
• headache, severe and throbbing
• joint or back pain
• muscle aching or cramping
• muscle pains or stiffness
• stuffy or runny nose

Incidence not known

• Diarrhea
• nausea
• vomiting

For Healthcare Professionals

Applies to tranexamic acid: compounding powder, intravenous solution, oral tablet.

Gastrointestinal

Gastrointestinal side effects have frequently included nausea, vomiting, and diarrhea. Abdominal pain has also been reported.^[Ref]

Nervous system

Nervous system side effects have included giddiness, dizziness, headache, tension headache, and migraine.^[Ref]

Hematologic

Hematologic side effects have included thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) and anemia.^[Ref]

Hypersensitivity

A case of severe allergic reaction to tranexamic acid (the active ingredient contained in Lysteda) was reported involving a subject on her fourth cycle of treatment who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.^[Ref]

Hypersensitivity side effects have included allergic skin reactions, anaphylactic shock and anaphylactoid reactions.^[Ref]

Ocular

Ocular side effects have rarely included disturbances of color vision and retinal artery occlusion.^[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, musculoskeletal pain, muscle cramps and spasms, myalgia, and arthralgia including joint stiffness and swelling.^[Ref]

Respiratory

Respiratory side effects have included nasal and sinus symptoms including nasal, respiratory tract and sinus congestion, sinusitis, acute sinusitis, sinus headache, and allergic sinusitis and sinus pain.^[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension when intravenous administration exceeded 1 mL per minute.^[Ref]

Genitourinary

Genitourinary side effects have included ureteral obstruction due to clot formation in patients with upper urinary tract bleeding.^[Ref]