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Tranexamic Acid

Tranexamic acid is an antifibrinolytic medication used to reduce or prevent bleeding in people with hemophilia around tooth extraction (injection forms) and to treat cyclic heavy menstrual bleeding (tablet form).

Brand names LystedaCyklokapronTranexamic Acid In Sodium Chloride
Drug class Antifibrinolytic Agent
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 32 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record · 2
Tranexamic Acid at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tranexamic acid, an antifibrinolytic around since about 1972 and available generically, keeps clots from breaking down by blocking plasmin from latching onto fibrin (the clot's protein mesh), and is used as tablets for heavy menstrual bleeding, a common non-hormonal option, or as an injection around tooth extraction in hemophilia. Most people tolerate it well, mainly noticing headache, sinus congestion or back pain. The boxed warning covers the injection, which goes only into a vein, because serious, sometimes fatal, seizures and heart rhythm problems followed accidental injection into the spine. The tablets must never be paired with combined hormonal birth control (pill, patch or ring), which sharply raises the risk of dangerous clots.

Clinical pearls

  • Swallow the tablets whole, never chewed or broken, and take them only during your period, for up to five days.
  • Stop the tablets and see an eye doctor promptly if your vision changes, since clots in the eye's blood vessels have been reported.
  • Get emergency care for leg swelling or pain, chest pain, sudden shortness of breath or a sudden severe headache.
  • Mention any past blood clot or stroke, which rules the tablets out, and any kidney problem, which can lower the dose.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

BOXED WARNING SECTION WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered via the neuraxial route [see Warnings and Precautions ( 5.1 )]. WARNING; RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION See full prescribing information for complete...

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection, Tablet
Earliest FDA record1972
Companies listing it with the FDA37
FDA label last updatedSep 8, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Tranexamic Acid, written from its FDA label.

What Tranexamic Acid is used for

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Tranexamic acid is an antifibrinolytic (anti-bleeding) medication approved across two forms for different conditions:

  • Cyklokapron injection and Tranexamic Acid injection (including Tranexamic Acid in Sodium Chloride): used in patients with hemophilia to reduce or prevent bleeding and reduce the need for clotting-factor replacement therapy for 2 to 8 days around a tooth extraction
  • Lysteda tablets and generic tranexamic acid tablets: used to treat cyclic heavy menstrual bleeding in females of reproductive age

How Tranexamic Acid works

▾

When you bleed, your body forms a fibrin clot — a protein mesh that plugs the wound. An enzyme called plasmin normally breaks that clot down. Tranexamic acid works by sitting in the exact spots on plasmin that it uses to grab onto fibrin, blocking the breakdown process. The clot stays intact longer, reducing bleeding. This is why tranexamic acid is called an antifibrinolytic — it fights the dissolving (fibrinolysis) of clots.

In women with heavy menstrual bleeding, higher-than-normal levels of a substance called tissue plasminogen activator (tPA) in the uterine lining break down clots too fast. Tranexamic acid lowers that activity during the period, reducing blood loss.

Tranexamic Acid dosage

▾

How and how often tranexamic acid is taken depends entirely on the form prescribed. Injections are given by a healthcare provider directly into a vein — once before a tooth extraction and then several times daily for up to 8 days afterward; patients with kidney disease receive adjusted doses. Tablets are taken by mouth multiple times a day for up to 5 days during each monthly period — not continuously — and can be taken with or without food, but must be swallowed whole.

  • Never chew or break tranexamic acid tablets
  • If you have kidney problems, your prescriber will lower your tablet dose
  • Follow your prescriber's exact instructions; do not adjust doses on your own

Dosing details from the FDA-approved label

From the Tranexamic Acid prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Before tooth extraction (hemophilia patients)
    • 10 mg/kg actual body weight intravenously as a single dose immediately before tooth extractions, with replacement therapy
    • Maximum: Infuse no more than 10 mL/minute (premix in sodium chloride); undiluted solution no more than 1 mL/minute, to avoid hypotension
  • After tooth extraction
    • 10 mg/kg actual body weight intravenously 3 to 4 times daily for 2 to 8 days
    • Infuse undiluted solution no more than 1 mL/minute (premix: no more than 10 mL/minute) to avoid hypotension
  • Renal impairment: serum creatinine 1.36 to 2.83 mg/dL (120 to 250 micromol/L)
    • 10 mg/kg intravenously twice daily
    • Dose reduction recommended for all doses, both before and after tooth extraction
  • Renal impairment: serum creatinine 2.83 to 5.66 mg/dL (250 to 500 micromol/L)
    • 10 mg/kg intravenously daily
    • Dose reduction recommended for all doses, both before and after tooth extraction
  • Renal impairment: serum creatinine >5.66 mg/dL (>500 micromol/L)
    • 10 mg/kg intravenously every 48 hours or 5 mg/kg intravenously every 24 hours
    • Dose reduction recommended for all doses, both before and after tooth extraction
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose. ( 2.1 ) • After Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously 3 to 4 times daily for 2 to 8 days. ( 2.1 ) • Infuse undiluted solution no more than 1 mL/minute to avoid hypotension. ( 2.3 ) • Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight administered as a single intravenous dose immediately before tooth extractions. Following tooth extraction, tranexamic acid injection may be administered at a dose of 10 mg/kg actual body weight intravenously 3 to 4 times daily for 2 to 8 days . 2.2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment For patients with moderate to severe impaired renal function, the following dosages are recommended: Table 1. Recommended Dosage in Patients With Varying Degrees of Renal Impairment Dose reduction is recommended for all doses, both before and after tooth extraction . Serum Creatinine (mg/dL) Tranexamic Acid Injection Dosage 1.36 mg/dL to 2.83 mg/dL 10 mg/kg intravenously twice daily 2.83 mg/dL to 5.66 mg/dL 10 mg/kg intravenously daily > 5.66 mg/dL 10 mg/kg intravenously every 48 hours or 5 mg/kg intravenously every 24 hours 2.3 Preparation and Administration Tranexamic acid injection is for intravenous administration only. Tranexamic acid injection can be administered undiluted or as a diluted solution. • Use aseptic technique to prepare tranexamic acid injection. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Tranexamic acid injection is a clear and colorless solution. Discard the vial if particulate matter is observed. • Calculate the dose (mg) based on the patient’s actual body weight and the total volume (mL) of tranexamic acid injection solution required. If diluting tranexamic acid injection , follow the instructions below: • From the diluent infusion bag, withdraw a volume equal to the volume of the tranexamic acid injection solution required for the patient’s dose.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Tranexamic Acid side effects

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The most common side effects reported with tranexamic acid tablets include:

Common side effects

  • Headache
  • Nasal and sinus congestion or pain
  • Back pain
  • Abdominal pain
  • Muscle or joint pain
  • Migraine
  • Fatigue
  • Anemia (low red blood cell count)
  • Muscle cramps

When to get medical help

  • Get emergency help right away if you have sudden difficulty breathing, throat tightening, or facial flushing — signs of a severe allergic reaction
  • Call your doctor immediately if you notice any changes in vision or eye symptoms — stop taking tranexamic acid tablets and see an eye doctor promptly
  • Seek immediate care for signs of a blood clot: leg swelling or pain, sudden shortness of breath, chest pain, or sudden severe headache
  • Tell your doctor right away if you develop nausea, vomiting, dizziness, or rash after taking more than prescribed
  • Report any sudden changes in mental status, muscle jerking (myoclonus), or low blood pressure

Serious reactions — including severe allergic reactions (trouble breathing, throat tightening, facial flushing), blood clots, vision changes, nausea, vomiting, diarrhea, and dizziness — have also been reported. Stop the medication and seek medical attention right away if any of these occur.

Tranexamic Acid warnings and precautions

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  • Blood clots (thromboembolism): This is the most critical risk. Blood clots in veins and arteries — including in the blood vessels of the eye — have been reported with tranexamic acid tablets. The risk is significantly higher if you also use combined hormonal contraceptives (pill, patch, ring), smoke, or are obese. This combination is contraindicated — these products must not be used together.
  • Vision changes: Any new visual symptoms mean you should stop tranexamic acid tablets immediately and see an eye doctor. Blockages in the retinal blood vessels and impaired color vision have been reported.
  • Severe allergic reactions: A case of anaphylaxis (a life-threatening allergic reaction) has been reported. Seek emergency care immediately for difficulty breathing, throat tightening, or severe flushing.
  • Ligneous conjunctivitis: A rare, thick inflammation of the eye lining has been reported; it resolved after stopping the medication.
  • Subarachnoid hemorrhage: Using tranexamic acid tablets in patients with bleeding around the brain may cause brain swelling or stroke — avoid this use.

Tranexamic Acid interactions

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Tranexamic acid tablets can interact with several medications, raising the risk of serious harm:

  • Combined hormonal contraceptives (pill, patch, ring): Both tranexamic acid and hormonal contraceptives increase clotting risk — together, the danger is significantly amplified. This combination is contraindicated (must not be used together).
  • Tissue plasminogen activators (tPA, clot-busting drugs): These work in the opposite direction from tranexamic acid. Using them together reduces the effectiveness of both drugs.
  • Factor IX complex concentrates or anti-inhibitor coagulant concentrates: Used in some bleeding disorders; combining with tranexamic acid tablets raises clot risk and is not recommended.
  • All-trans retinoic acid (oral tretinoin) in acute promyelocytic leukemia: Tranexamic acid may worsen the clot-promoting effect of this cancer treatment and is not recommended in this setting.

Interactions listed in the FDA-approved label

From the Tranexamic Acid prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Combined hormonal contraceptives: Because tranexamic acid is antifibrinolytic, concomitant use may increase the thrombotic risk associated with combined hormonal contraceptives. Concomitant use is contraindicated.
  • Tissue plasminogen activators: Concomitant therapy may decrease the efficacy of both tranexamic acid and tissue plasminogen activators. Discontinue tranexamic acid if a patient requires tissue plasminogen activators.
  • Factor IX complex concentrates or anti-inhibitor coagulant concentrates: The risk of thrombosis may be increased. Tranexamic acid is not recommended in patients taking these.
  • All-trans retinoic acid (oral tretinoin): Possible exacerbation of the procoagulant effect of all-trans retinoic acid in patients with acute promyelocytic leukemia. Not recommended in patients with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction.
Read the label’s full interactions text

7 DRUG INTERACTIONS Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.2 , 7.1 , 8.3 ) See 17 for PATIENT COUNSELING INFORMATION. 7.1 Prothrombotic Medical Products Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions (5.2) , Use in Specific Populations (8.3) ].

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿17 supplements and herbs with documented Tranexamic Acid interactions, ranked by severity Check Tranexamic Acid against a supplement or herb →

Before taking Tranexamic Acid

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  • Tell your prescriber if you have ever had a blood clot — deep vein thrombosis, pulmonary embolism, stroke, or a blockage in a retinal blood vessel — as tranexamic acid tablets are contraindicated in these cases
  • Tell your prescriber if you have a thrombogenic heart valve condition or a clotting disorder that puts you at higher baseline risk
  • Do not use tranexamic acid tablets if you are currently using combined hormonal contraception
  • Tranexamic acid tablets are not approved for use in pregnant women or postmenopausal women
  • Tranexamic acid tablets are not for use in girls who have not yet started their period (premenarchal)
  • If you are breastfeeding, discuss with your doctor — the drug passes into breast milk in small amounts and the effects on a nursing infant are not fully known
  • Kidney disease: dose must be reduced; tell your prescriber about any kidney problems
  • Liver disease: no dose adjustment needed for tablets, but always disclose your full health history
  • If you have or have had subarachnoid hemorrhage (bleeding around the brain), tranexamic acid tablets are not appropriate

Tranexamic Acid overdose

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Symptoms of taking too much tranexamic acid may include nausea, vomiting, diarrhea, dizziness or low blood pressure, blood clots, vision problems, changes in mental status, muscle jerking (myoclonus), or a rash. There is no specific antidote. If an overdose is suspected, seek medical care right away and supportive treatment will be provided based on your symptoms.

What Tranexamic Acid does in the body

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Tranexamic acid reduces the rate at which plasmin breaks down fibrin clots. In women with heavy menstrual bleeding, it lowers the elevated tissue plasminogen activator (tPA) activity found in the uterine lining, which in turn reduces how much blood is lost during a period. At typical therapeutic blood levels, tranexamic acid does not affect platelet count or most clotting factors, though it can prolong the thrombin time (a lab measure of clotting speed) at higher concentrations. Studies of the tablet form found no meaningful effect on the heart's electrical activity (QT interval) at standard or higher-than-standard doses.

How your body processes Tranexamic Acid

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When taken as a tablet, tranexamic acid reaches peak blood levels in about 2.5 hours and has an absolute bioavailability of roughly 45% — meaning less than half of each dose reaches the bloodstream unchanged. It is barely bound to proteins in the blood and is cleared mainly by the kidneys, with more than 95% excreted unchanged in urine. The terminal half-life (the time for blood levels to fall by half) is approximately 11 hours with oral dosing. Because the kidneys do nearly all the work of clearing this drug, lower doses are needed when kidney function is reduced; since so little is metabolized by the liver, liver disease does not require a dose change. Food slightly increases absorption but does not meaningfully change overall exposure.

How to store Tranexamic Acid

▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

17

Supplements & herbs that interact with Tranexamic Acid

17 supplements and herbal products have documented interactions with Tranexamic Acid in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +9 more
Every supplement checked against Tranexamic Acid — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Tranexamic Acid against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Tranexamic Acid: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Tranexamic Acid — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is tranexamic acid used for?

▾
It depends on the form you've been prescribed. If you're taking it as a tablet (brand name Lysteda, or a generic), it's to treat heavy menstrual bleeding — you take it only during your period, not all month long. If you're receiving it as an IV injection in a clinic or hospital, it's used in people with hemophilia to prevent or reduce bleeding around the time of a tooth extraction. It's not a hormone and it doesn't thin your blood — it actually helps clots stay in place longer.

Can I take tranexamic acid tablets with my birth control pill?

▾
No — this is one of the most important things to know. Taking tranexamic acid tablets together with combined hormonal contraceptives (the pill, patch, or ring) is contraindicated, meaning it's not safe to combine them. Both tranexamic acid and hormonal birth control can raise your risk of blood clots, and together that risk goes up significantly. If you need birth control while taking tranexamic acid tablets, talk to your doctor about non-hormonal options.

What side effects should I watch out for?

▾
The most common ones are headache, nasal or sinus congestion, back pain, and abdominal discomfort — most people tolerate the drug reasonably well for the short time it's taken each month. What you want to act on quickly are vision changes of any kind (stop the medication right away and call your doctor), signs of a blood clot like leg swelling, chest pain, or sudden shortness of breath, or any severe allergic reaction like trouble breathing or throat tightening. Those need emergency care.

How do I take the tablets correctly?

▾
You take them multiple times a day for up to 5 days during your period — not every day of the month. You can take them with or without food, whichever is easier on your stomach. The key thing is to swallow the tablets whole — don't chew or break them apart. If you have kidney problems, your dose will be lower than the standard amount, so make sure your prescriber knows about your kidney function.

Is it safe to use tranexamic acid if I'm pregnant or breastfeeding?

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The tablets are not approved for use during pregnancy, so this would need a careful conversation with your doctor. The drug does cross the placenta. If you're breastfeeding, small amounts of tranexamic acid do pass into breast milk — the effects on a nursing baby aren't fully established, so weigh this with your doctor based on your individual situation and how much you need the medication.

How long does it take to work, and do I have to take it every month?

▾
For heavy menstrual bleeding, tranexamic acid tablets are taken each time you have your period — up to 5 days per cycle. You don't take them in between periods. Blood levels build up within a few hours of the first dose. Because it's only used during your period, it's not a long-term daily medication; think of it as treatment you use each month when you need it, for as long as your prescriber recommends.

Is Tranexamic Acid available over the counter?

▾
No. Tranexamic Acid is a prescription medicine: every Tranexamic Acid product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tranexamic Acid first available?

▾
The earliest FDA record we hold for Tranexamic Acid is from 1972: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tranexamic Acid was first used.

Who makes Tranexamic Acid?

▾
37 companies currently list Tranexamic Acid products in the FDA's NDC Directory, including Bryant Ranch Prepack, Armas Pharmaceuticals Inc., Avenacy Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Tranexamic Acid on HelloPharmacist

📊Tranexamic Acid supplement interactions17 checked — ranked by severity 🌿Drug & Supplement CheckerTranexamic Acid vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Tranexamic Acid NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Tranexamic Acid Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tranexamic Acid forms and strengths (how it comes)

Tranexamic Acid is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tranexamic Acid inactive ingredients by manufacturer.

Injection

Into a vein
Brands Cyklokapron Tranexamic Acid In Sodium Chloride
How this form is used
What it may be used for
  • Cyklokapron is indicated in patients with hemophilia to reduce or prevent bleeding and reduce the need for clotting-factor replacement therapy during and after tooth extraction (short-term use, 2 to 8 days)
  • Tranexamic Acid in Sodium Chloride injection is indicated in patients with hemophilia for the same short-term purpose around tooth extraction
  • Tranexamic Acid injection is indicated in patients with hemophilia to reduce or prevent bleeding around tooth extraction
Important instructions
  • All injection forms are given intravenously (into a vein) by a healthcare provider — not for self-administration at home
  • Cyklokapron: infuse the undiluted solution no faster than 1 mL/minute to avoid a drop in blood pressure
  • Tranexamic Acid in Sodium Chloride injection: infuse no more than 10 mL/minute to avoid low blood pressure
  • Patients with kidney problems require a lower dose for all injection products — your provider will adjust accordingly
Available strengths 3 strengths
10 mg/mL 100 mg/mL 1 g/10 mL
69 FDA-listed product records ⓘ

Tablet

By mouth
Brands Lysteda
How this form is used
What it may be used for
  • Lysteda (tranexamic acid tablets) is indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive age
  • Generic tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive age
Important instructions
  • Take tranexamic acid tablets multiple times a day for up to 5 days during each menstrual period — not every day of the month
  • Tablets may be taken with or without food
  • Swallow tablets whole — do not chew or break them apart
  • Patients with kidney problems need a lower dose; follow your prescriber's specific guidance
Available strengths 1 strength
650 mg
27 FDA-listed product records ⓘ

Tranexamic Acid on the U.S. market: products, makers and brands

How Tranexamic Acid appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

37 companies list 50 Tranexamic Acid product records with the FDA, mostly as injection, tablet; the earliest marketing or approval year on record is 1972. Brand names on the directory include Lysteda, Cyklokapron, Tranexamic Acid In Sodium Chloride; the rest are generics.

2
Dose forms ⓘ
37
Labelers (makers, repackagers, distributors)
3
Brand names
50
FDA-listed product records ⓘ
1972
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack8%
Armas Pharmaceuticals Inc.4%
Avenacy Inc.4%
Gland Pharma Limited4%
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4%
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.4%
Other makers72%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Tranexamic Acid is used (Medicaid data)

A general measure of how commonly Tranexamic Acid is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tranexamic Acid is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

131,595
Medicaid prescriptions filled (Q1–Q4 2025)
$6.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tranexamic Acid prescribed? Of the 1,601 medications we measure, Tranexamic Acid ranks #469 by Medicaid prescriptions — more than 71% of them.

Where Tranexamic Acid ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #469 of 1,601
#464 Desonide Topical 133,862 Rx #465 Desonide 133,862 Rx #466 Liothyronine 133,453 Rx #467 Dextroamphetamine 132,973 Rx #468 Epinephrine / Lidocain... 132,083 Rx #469 Tranexamic Acid 131,595 Rx #470 Olanzapine / Samidorph... 130,976 Rx #471 Bisoprolol 130,591 Rx #472 Miconazole 130,151 Rx #473 Bisacodyl Rectal 127,528 Rx #474 Fluphenazine 127,346 Rx

Utilization by Tranexamic Acid product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 650 mg oral tablet is the most-dispensed Tranexamic Acid product — about 95% of these Medicaid prescriptions.

tranexamic acid 650 MG Oral Tablet Most dispensed

124,364 Medicaid prescriptions (Q1–Q4 2025) 95% of Tranexamic Acid prescriptions shown $5.9M gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 6 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 883826

10 ML tranexamic acid 100 MG/ML Injection

4,592 Medicaid prescriptions (Q1–Q4 2025) 3% of Tranexamic Acid prescriptions shown $599,136 gross reimbursement (before rebates) ≈ $130 per prescription (gross)

Summed across the 15 of 75 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238720

100 ML tranexamic acid 10 MG/ML Injection

2,639 Medicaid prescriptions (Q1–Q4 2025) 2% of Tranexamic Acid prescriptions shown $368,699 gross reimbursement (before rebates) ≈ $140 per prescription (gross)

Summed across the 5 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2170286

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tranexamic Acid, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 26 of 120 listed Tranexamic Acid NDCs with Medicaid activity.

Compare Tranexamic Acid products

A representative set of FDA-listed product records for Tranexamic Acid — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 50 of 50 products — FDA National Drug Code Directory. See every product, package size and price: browse all 50 Tranexamic Acid NDCs →

Tranexamic Acid side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tranexamic Acid — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Tranexamic Acid are pyrexia, nausea, hypotension; about 93% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

8,840
Reports mentioning it
93%
Reported as serious
12
Distinct effects shown
Most reported effects
Pyrexia
366
Nausea
340
Hypotension
325
Diarrhoea
313
Vomiting
304
Haemorrhage
302
Dyspnoea
287
Pneumonia
274
Febrile Neutropenia
261
Headache
241
Age groups
Adult · 962Elderly · 425Adolescent · 124Child · 82Neonate · 41Infant · 31

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tranexamic Acid in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Tranexamic Acid FDA approval history

How Tranexamic Acid went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Tranexamic Acid was first approved by the FDA in 1972; the first generic version was approved in 2011. It remains available in U.S. pharmacies today.

1972
First FDA approval
2011
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Tranexamic Acid recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 3 Tranexamic Acid recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Jun 13, 2023 · AVKARE LLC
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
  • Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 Lots: Lot: 44286 Exp. 02/2025 FDA record D-0875-2023 →
Ongoing Class III Sep 26, 2022 · AuroMedics Pharma LLC
Presence of Particulate Matter: Piece of metal found in a vial
  • Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10 Lots: Lot: CTA210006, Exp. 02/2024 FDA record D-1551-2022 →
Class III Jun 12, 2023 · Terminated · Amring Pharmaceuticals Inc
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
  • Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 Lots: Lots: X220317A and X220318A, exp. date 09/25 FDA record D-0871-2023 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tranexamic Acid RxCUI 10691 2 dose forms · 4 strengths
  2. Dose form (SCDF) Oral Tablet RxCUI 374181 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 104481 650 MG RxCUI 883826

Look up RxCUI 10691 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Tranexamic Acid costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Injection, Solution · Intravenous 1 g/10 mL $0.404 per mL NDC details & price history
Tablet · Oral 650 mg $0.834 per tablet NDC details & price history
Tablet, Film Coated · Oral 650 mg $0.834 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Tranexamic Acid brand names

Tranexamic Acid is sold under 3 brand names in the FDA directory — Lysteda, Cyklokapron, Tranexamic Acid In Sodium Chloride. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lysteda Cyklokapron Tranexamic Acid In Sodium Chloride

Who makes Tranexamic Acid: manufacturers and labelers

37 companies list Tranexamic Acid products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Armas Pharmaceuticals Inc., Avenacy Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 4 Armas Pharmaceuticals Inc. 2 Avenacy Inc. 2 Gland Pharma Limited 2 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2 Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. 2 Micro Labs Limited 2 Milla Pharmaceuticals Inc. 2 NorthStar Rx LLC 2 Provepharm Inc. 2 Sagent Pharmaceuticals 2 Advagen Pharma Limited 1 ANI Pharmaceuticals, Inc. 1 Actavis Pharma, Inc. 1 American Health Packaging 1 Amneal Pharmaceuticals LLC 1 Amneal Pharmaceuticals Private Limited 1 Apotex Corp. 1 Aurobindo Pharma Limited 1 AvPAK 1 Baxter Healthcare Corporation 1 Caplin Steriles Limited 1 Dr. Reddy's Laboratories Inc. 1 Emcure Pharmaceuticals Limited 1

…and 13 more on the FDA NDC directory.

Tranexamic Acid drug class (RxNorm)

Tranexamic Acid belongs to the Antifibrinolytic Agent class.

Pharmacologic class Antifibrinolytic Agent
Drug family (ATC) Amino acids

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Tranexamic Acid page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 8, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tranexamic Acid.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tranexamic Acid after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
32
Finished products in the current FDA directory
50
Companies listing them (makers, repackagers, distributors)
37
FDA labeler codes behind them ⓘ
37
Linked representative label ⓘ
Mylan Institutional LLC
Linked label effective
Sep 8, 2025
Composite sections available
22
Linked SPL Set ID
6f033f1e-8c78-4c87-b870-6493944315ff
Linked SPL Document ID
a7994e55-1e4d-45bc-bb2c-52b63e4ad408
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Institutional LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →