Lysteda Side Effects

Generic name: tranexamic acid

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

Some side effects of Lysteda may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tranexamic acid: compounding powder, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tranexamic acid (the active ingredient contained in Lysteda) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Lysteda and call your doctor at once if you have a serious side effect such as:

• problems with your vision (including color vision);

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• sudden chest pain or trouble breathing;

• pain or swelling in one or both legs;

• migraine headache;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• feeling like you might pass out.

Less serious side effects include:

• mild headache;

• runny or stuffy nose;

• stomach pain;

• tired feeling;

• eye redness; or

• back pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Nervous system

Nervous system side effects have included giddiness, dizziness, headache, tension headache, and migraine.

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.

Hypersensitivity

Hypersensitivity side effects have included allergic skin reactions, anaphylactic shock and anaphylactoid reactions.

A case of severe allergic reaction to tranexamic acid 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.

Ocular

Ocular side effects have rarely included disturbances of color vision and retinal artery occlusion.

Musculoskeletal

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

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.

Cardiovascular

Cardiovascular side effects have included hypotension when intravenous administration exceeded 1 mL per minute.

Genitourinary

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

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