Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for tranexamic acid, the active ingredient registered with NAFDAC.
Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )
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 . …
Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. In patients with active intravascular clotting [see Warnings and Precautions ( 5.1 )] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ( 5.4 )] . …
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. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. …
8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. …
Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. …
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Unotation Injection contains Tranexamic Acid (100 mg), as injection, according to its NAFDAC registration record.
Yes. Unotation Injection is listed on the NAFDAC register under registration number B4-8451, and its registration is active as of 27 October 2026.
No WHO falsified or substandard medical product alert currently matches Unotation Injection in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-8451, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for repl (Summarised from the official U.S. FDA label for tranexamic acid. Always follow your doctor or pharmacist.)
Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.