Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Visual Disturbances [see Warnings and Precautions ( 5.5 )] Dizziness [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc.
at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction.
Allergic dermatitis and giddiness have been reported.
Hypotension has been reported when intravenous injection is too rapid.
Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia.
Convulsion, cromatopsia, and visual impairment have also been reported.
5 WARNINGS AND PRECAUTIONS Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use.
( 5.1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY.
( 5.2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures.
( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention.
( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur.
Like all medications, Tranexamic Acid can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: