FDA-filed SPL labeling · retrieved through openFDA

Aminocaproic Acid

Aminocaproic acid is a medication that helps stop abnormal bleeding by slowing the breakdown of blood clots, used across injection and oral forms in serious bleeding situations linked to surgery, blood disorders, and certain diseases.

Brand names Amicar Oral SolutionAmicar TabletsAmicar
Drug class ⓘ Antifibrinolytic Agent
Rx Forms 3 Routes Oral · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 21 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 →

At a glance
Linked label effectiveJan 8, 2024
Clinical labels in scope ⓘ21
AvailabilityRx
Earliest approval/marketing year ⓘ1981
FDA-listed product records ⓘ82
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026 🚨Recall on record
Other forms & routes:
Injection
⭐ Aminocaproic Acid at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Aminocaproic acid is a short-term, hospital-level treatment for serious bleeding caused by the body breaking down clots too quickly. It can be life-saving in the right situation but carries real risks — including muscle damage with prolonged use and dangerous clot formation if used in the wrong type of bleeding disorder. Always use it exactly as directed by your medical team.
How we write & review this content — our editorial policy →

📖 Aminocaproic Acid: Patient Information Guide

A plain-language walkthrough of Aminocaproic Acid — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Aminocaproic acid is used across injection and oral forms to control serious bleeding caused by the body breaking down blood clots too quickly — a process called fibrinolysis. Below are the conditions it is used for:

  • Bleeding complications after heart surgery (with or without cardiac bypass) or portacaval shunt surgery
  • Bleeding linked to liver cirrhosis
  • Blood disorders such as aplastic anemia (and the related low-platelet condition amegakaryocytic thrombocytopenia, as noted in the oral forms)
  • Abruptio placentae — a life-threatening pregnancy complication where the placenta separates from the uterus early
  • Bleeding associated with cancers of the prostate, lung, stomach, or cervix
  • Urinary tract bleeding after procedures such as prostatectomy (prostate surgery) or nephrectomy (kidney removal)
  • Urinary tract bleeding accompanying polycystic or cancerous diseases of the genitourinary system
⚙️How it works▾

Aminocaproic acid works by blocking the proteins called plasminogen activators — the triggers that start the clot-dissolving process in the body. By stopping those triggers, it prevents plasmin (the enzyme that physically breaks apart clots) from forming and doing its work. The result is that blood clots are allowed to stay intact long enough to stop bleeding. To a lesser extent, it also directly interferes with plasmin activity itself.

💊How it's taken▾

Aminocaproic acid comes in three forms: an intravenous (IV) injection, an oral solution, and oral tablets. The IV form is always given in a hospital setting as a slow, diluted drip — never as a rapid injection. The oral forms are taken by mouth when a patient is able to do so, and may follow the same treatment schedule as the IV form. Treatment is typically short-term — about 8 hours or until bleeding is controlled — though your medical team will decide the exact duration based on your situation.

  • The IV injection must be diluted before use and infused slowly
  • The oral solution and tablets are taken by mouth on a schedule set by your prescriber
  • Always follow your care team's exact instructions — do not adjust doses or timing on your own
🤒Side effects — in detail▾

Aminocaproic acid is generally tolerated, but side effects can occur. Common ones include:

  • Nausea, vomiting, diarrhea, or stomach pain
  • Headache or dizziness
  • Muscle aches, weakness, or elevated muscle enzymes (CPK)
  • Low blood pressure (hypotension) or slow heartbeat (bradycardia)
  • Skin rash or itching
  • Nasal congestion or shortness of breath
  • Watery eyes or mild vision changes
  • Dry ejaculation (reported in hemophilia patients after dental procedures; resolved within 24–48 hours of stopping treatment)

Serious reactions to act on immediately include signs of severe allergic reaction (anaphylaxis), signs of muscle breakdown (dark urine, severe weakness), seizures, stroke symptoms, blood clots, or kidney failure — contact your care team or seek emergency help right away if any of these occur.

⚠️Warnings & precautions▾
  • Muscle damage risk: Prolonged use can cause serious muscle breakdown (rhabdomyolysis) — from mild aching to severe muscle failure with kidney damage. Long-term patients should have CPK (a muscle enzyme) levels monitored. Stop the drug if CPK rises.
  • Do not use in active blood vessel clotting (intravascular clotting or DIC): Using aminocaproic acid when clots are forming inside blood vessels can be life-threatening. It must not be used for DIC unless heparin is given at the same time.
  • Upper urinary tract bleeding risk: The drug can form clots that block the kidney or ureters. It should not be used for bleeding that originates in the upper urinary tract unless benefits clearly outweigh risks.
  • Benzyl alcohol in the injection: Aminocaproic Acid Injection contains benzyl alcohol as a preservative, which has been linked to a fatal "Gasping Syndrome" in premature newborns.
  • Cardiac and liver damage: Rare but serious heart and liver tissue damage has been reported. If muscle problems develop, the possibility of heart muscle damage should also be considered.
🔀What it interacts with▾

The FDA label for aminocaproic acid does not detail specific drug, food, or supplement interactions. Always tell your prescriber and pharmacist about every medication, supplement, or herbal product you take before starting aminocaproic acid.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use aminocaproic acid if you have active clotting inside your blood vessels (intravascular clotting), as it can make this worse
  • It must not be used for disseminated intravascular coagulation (DIC) without also receiving heparin
  • Tell your doctor if you have kidney disease — the drug is cleared almost entirely by the kidneys, and clearance is significantly reduced in severe kidney failure
  • Tell your care team if the patient is a premature newborn — the injectable form contains benzyl alcohol, which can cause serious harm in premature infants
  • Do not use for upper urinary tract bleeding without careful evaluation, as it can cause dangerous blockages in the kidney or ureters
  • Tell your doctor if you have a history of seizures before receiving this medication
🚑If you take too much▾

Taking too much aminocaproic acid can range from causing no symptoms to serious outcomes including acute kidney failure. Seizures have been reported after a large bolus dose, especially in patients with a seizure history. There is no specific antidote, but the drug can be removed through hemodialysis or possibly peritoneal dialysis, and your medical team will manage symptoms as needed.

📡Pharmacodynamics — effects in the body▾

Aminocaproic acid reduces the body's ability to break down blood clots by blocking the proteins that activate this process. The main measurable effect is stabilization of existing clots, which slows or stops fibrinolytic bleeding. This effect is most useful when the bleeding is driven by overactive fibrinolysis rather than by a failure to form clots in the first place.

🔬Pharmacokinetics — how your body processes it▾

When taken orally, aminocaproic acid is absorbed quickly and completely — peak blood levels are reached within about 1 to 1.2 hours after a dose. The drug distributes widely through the body, reaching both fluid spaces and red blood cells. It is cleared mainly by the kidneys: about 65% leaves the body unchanged in urine, and 11% is converted to a metabolite called adipic acid. The half-life — the time it takes the body to clear half the drug — is approximately 2 hours, meaning it does not linger long in the system under normal conditions.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) ; Dispense in Tight Containers.

📄 Written from Aminocaproic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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

What is aminocaproic acid actually used for? ▾
It's used to control serious or life-threatening bleeding that happens because your body is breaking down blood clots too fast — a process called fibrinolysis. You might receive it after heart surgery, if you have liver disease, certain blood disorders, or specific types of cancer that cause this kind of bleeding. It can also be used for certain types of urinary tract bleeding after surgical procedures.
Will I take this as a pill or through an IV? ▾
It depends on your situation. In a hospital, it's often given through an IV as a slow drip — never a fast injection. If you're able to take medication by mouth, your doctor may switch you to the oral tablet or oral solution form. Both forms follow a similar treatment schedule, but your care team will decide which is right for you.
How long will I need to take it? ▾
Treatment with aminocaproic acid is typically short-term — often around 8 hours or until the bleeding is under control. The exact duration depends on your specific medical situation. Your prescriber will determine how long you need it, so don't stop or continue it beyond what they advise.
What side effects should I watch out for? ▾
Nausea, stomach upset, dizziness, and muscle aches are the more common ones. The more serious things to watch for are severe muscle weakness combined with dark-colored urine — that can mean muscle breakdown, which can hurt your kidneys. Also call your doctor right away if you have signs of a severe allergic reaction, confusion, seizures, chest pain, or you notice swelling that could suggest a blood clot.
Is there anyone who shouldn't take this medication? ▾
Yes — aminocaproic acid should not be used if you have active clotting happening inside your blood vessels, because blocking clot breakdown in that situation can be very dangerous. It also needs to be used with extreme caution if the bleeding is coming from your upper urinary tract, since it can form clots that block the kidneys. Always make sure your doctor knows your full medical history before you start this medication.
Can this medication affect my kidneys? ▾
Yes, kidney health matters here. The drug is cleared almost entirely through the kidneys, so if your kidneys aren't working well, the medication can build up in your body. In rare cases — especially with overdose — acute kidney failure has been reported. Your care team will monitor for signs of kidney problems, especially with longer treatment or higher doses.
Is Aminocaproic Acid available over the counter? ▾
Aminocaproic Acid is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Aminocaproic Acid first available? ▾
Aminocaproic Acid has been available in the United States since at least 1981, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Aminocaproic Acid? ▾
Aminocaproic Acid is supplied by 41 manufacturers listed in the FDA NDC Directory, including Akorn Operating Company LLC, Amneal Pharmaceuticals NY LLC, Leading Pharma, LLC.

💬 Answers drafted from Aminocaproic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Aminocaproic Acid comes

Aminocaproic Acid is available in 3 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.

Tablet

By mouth
Brands Amicar
How this form is used
What it may be used for
  • Amicar and Aminocaproic acid tablets are used to control bleeding when fibrinolysis (excessive clot breakdown) is the cause
  • Used for bleeding associated with heart surgery, liver cirrhosis, certain blood disorders, abruptio placentae, and certain cancers
  • Used for urinary tract bleeding following prostatectomy, nephrectomy, or with certain kidney or genitourinary diseases
Important instructions
  • Aminocaproic acid tablets are taken by mouth when the patient is able to swallow medication
  • Treatment is typically continued for about 8 hours or until bleeding is controlled, per your prescriber's instructions
  • Follow your prescriber's exact directions for dose timing
Available strengths 2 strengths
500 mg 1000 mg
35 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Amicar
How this form is used
What it may be used for
  • Amicar and Aminocaproic Acid oral solution are used to control bleeding when fibrinolysis (excessive clot breakdown) is the cause
  • Used for bleeding associated with heart surgery, liver cirrhosis, certain blood disorders, abruptio placentae, and certain cancers
  • Used for urinary tract bleeding following prostatectomy, nephrectomy, or with certain kidney diseases
Important instructions
  • Aminocaproic acid oral solution is taken by mouth and may be used when the patient is able to swallow medication
  • Treatment is typically continued for about 8 hours or until bleeding is controlled, following your prescriber's schedule
  • Follow your prescriber's exact instructions for timing and amount of each dose
Available strengths 1 strength
0.25 g/mL
26 FDA-listed product records ⓘ

Injection

Into a vein
How this form is used
What it may be used for
  • Aminocaproic Acid Injection is used to control serious bleeding when the body is breaking down blood clots too quickly (fibrinolysis)
  • Used for bleeding complications after heart surgery, liver cirrhosis, aplastic anemia, abruptio placentae, and certain cancers
  • Used for life-threatening urinary tract bleeding following procedures such as prostatectomy or nephrectomy
Important instructions
  • Aminocaproic Acid Injection must always be diluted and given as a slow IV infusion — never injected rapidly undiluted into a vein
  • Compatible diluents include Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose, and Ringer's Injection
  • Treatment is typically continued for about 8 hours or until bleeding is controlled, per your care team's guidance
  • Inspect the solution for particles or discoloration before use; do not use if either is present
Available strengths 1 strength
250 mg/mL
12 FDA-listed product records ⓘ

📊 Aminocaproic Acid across the U.S. market

How Aminocaproic 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.

3
Dose forms ⓘ
41
Manufacturers
2
Brand names
82
FDA-listed product records ⓘ
1981
First marketed ⓘ

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 (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Akorn Operating Company LLC7%
Amneal Pharmaceuticals NY LLC6%
Leading Pharma, LLC6%
American Health Packaging5%
Puracap Laboratories Llc Dba Blu Pharmaceuticals5%
Novadoz Pharmaceuticals LLC5%
Other makers65%

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

📈 How widely Aminocaproic Acid is used

A general measure of how commonly Aminocaproic 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 Aminocaproic 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.

5,657
Medicaid prescriptions filled (Q1–Q4 2025)
$2.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Aminocaproic Acid prescribed? Of the 1,596 medications we measure, Aminocaproic Acid ranks #1,030 by Medicaid prescriptions — more than 35% of them.

Where Aminocaproic Acid ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,030 of 1,596
#1,025 Deferoxamine 5,720 Rx #1,026 Doravirine, Lamivudine... 5,704 Rx #1,027 Tolvaptan (low blood s... 5,692 Rx #1,028 Tolvaptan (kidney dise... 5,692 Rx #1,029 Tolvaptan 5,692 Rx #1,030 Aminocaproic Acid 5,657 Rx #1,031 Ceftazidime Injection 5,585 Rx #1,032 Methylergonovine 5,549 Rx #1,033 Dalbavancin Injection 5,497 Rx #1,034 Rivastigmine Transderm... 5,404 Rx #1,035 Levofloxacin Injection 5,358 Rx

Utilization by Aminocaproic 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 250 mg/mL oral solution is the most-dispensed Aminocaproic Acid product — about 87% of these Medicaid prescriptions.

6-aminocaproic acid 250 MG/ML Oral Solution Most dispensed

4,940 Medicaid prescriptions (Q1–Q4 2025) 87% of Aminocaproic Acid prescriptions shown $2M gross reimbursement (before rebates) ≈ $399 per prescription (gross)

Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 582299

6-aminocaproic acid 500 MG Oral Tablet

493 Medicaid prescriptions (Q1–Q4 2025) 9% of Aminocaproic Acid prescriptions shown $127,657 gross reimbursement (before rebates) ≈ $259 per prescription (gross)

Summed across the 4 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197351

6-aminocaproic acid 1000 MG Oral Tablet

224 Medicaid prescriptions (Q1–Q4 2025) 4% of Aminocaproic Acid prescriptions shown $167,013 gross reimbursement (before rebates) ≈ $746 per prescription (gross)

Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 476271

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 Aminocaproic 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 12 of 46 listed Aminocaproic Acid NDCs with Medicaid activity.

🔍 Compare Aminocaproic Acid products

A representative set of FDA-listed product records for Aminocaproic 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 82 of 82 products — FDA National Drug Code Directory. See every product, package size and price: browse all 82 Aminocaproic Acid NDCs →

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) Aminocaproic Acid RxCUI 99 4 dose forms · 5 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 379238 In current FDA listings
    Clinical drug / strength (SCD) 250 MG/ML RxCUI 238719
  3. Dose form (SCDF) Oral Solution RxCUI 582298 In current FDA listings
    Clinical drug / strength (SCD) 250 MG/ML RxCUI 582299
  4. Dose form (SCDF) Oral Tablet RxCUI 378772 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 197351 1000 MG RxCUI 476271

Look up RxCUI 99 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.

🏷️ Sold under these brand names

Amicar Oral Solution Amicar Tablets Amicar

🏭 Manufacturers & labelers

Akorn Operating Company LLC 6 Amneal Pharmaceuticals NY LLC 5 Leading Pharma, LLC 5 American Health Packaging 4 Puracap Laboratories Llc Dba Blu Pharmaceuticals 4 Novadoz Pharmaceuticals LLC 4 Carnegie Pharmaceuticals, LLC 4 Vitruvias Therapeutics 3 Major Pharmaceuticals 3 Hospira, Inc. 3 Henry Schein, Inc. 3 Bpi Labs Llc 3 Biocon Pharma Inc. 3 Medical Purchasing Solutions, LLC 2 Darmerica, Llc 2 American Regent, Inc. 2 Hikma Pharmaceuticals USA Inc. 2 Sekisui Medical Co., Ltd. 1 MSN Life Sciences Private Limited 1 Amneal Pharmaceuticals LLC 1 Optimus Drugs Private Limited 1 Raks Pharma Pvt. Limited 1 ANI Pharmaceuticals, Inc. 1 Sionc Pharmaceutical Private Limited 1

…and 16 more on the FDA NDC directory.

RxNorm drug class

Aminocaproic 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.

🔬 Where this comes from

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 Jan 8, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Aminocaproic 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 Aminocaproic Acid after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
82
Distinct labelers/manufacturers represented
41
Linked representative label ⓘ
Hikma Pharmaceuticals USA Inc.
Linked label effective
Jan 8, 2024
Composite sections available
15
Linked SPL Set ID
7b8f0ddb-00fd-4c22-afae-afe636f95f3a
Linked SPL Document ID
7b8f0ddb-00fd-4c22-afae-afe636f95f3a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.