Prescription medicine
Aminocaproic acid First approved as Amicar
Aminocaproic acid (Amicar) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $0.574 per mL (Aminocaproic acid 0.25 gram/mL) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the aminocaproic acid FDA label on DailyMed (effective January 8, 2024, Hikma Pharmaceuticals USA Inc.); the NDA 15197 record on Drugs@FDA; every aminocaproic acid label on DailyMed.
Highlights of the record
FDA label of January 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding.
Forms and strengths
- 500 mg
- 1000 mg
- 0.25 g/ml
- 250 mg/ml
Tablet; solution; injection (solution); syrup.
On the market
- Earliest approval on file
- June 3, 1964 Amicar, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 26 first June 17, 1986; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 21 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.574 per mL Aminocaproic acid 0.25 gram/mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest July 24, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 765 through July 30, 2026
What is aminocaproic acid used for?
From the label: indications and usageAminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. […]
FDA pharmacologic class: Antifibrinolytic Agent.
Source: FDA drug label (Aminocaproic Acid), Hikma Pharmaceuticals USA Inc., effective January 8, 2024 (SPL set 7b8f0ddb-00fd-4c22-afae-afe636f95f3a), via openFDA; the full label on DailyMed
Is there a generic for aminocaproic acid (Amicar)?
The FDA approved the first generic aminocaproic acid on June 17, 1986. 26 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists aminocaproic acid from 21 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1964 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aminocaproic acid (Amicar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.574 per mL (Aminocaproic acid 0.25 gram/mL), down 44% from $1.03 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aminocaproic acid 0.25 gram/mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aminocaproic acid 0.25 gram/mL | Generic | $0.574 per mL | n/a | -44% |
| Aminocaproic acid 1,000 mg tablet | Generic | $8.31 per tablet | $249.37 | +1% |
| Aminocaproic acid 500 mg tablet | Generic | $2.52 per tablet | $75.71 | -28% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has aminocaproic acid been recalled?
The FDA's Enforcement Report lists 5 recalls naming aminocaproic acid since 2013: 0 Class I (the most serious), 4 Class II, 1 Class III; 3 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of aminocaproic acid and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2026 | Class II | American Regent, Inc. | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| October 17, 2023 | Class III | VistaPharm LLC | Failed Excipient Specifications: high content of ethylene glycol (EG) |
| September 14, 2017 | Class II | Medisca, Inc. not a listed maker | CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use. |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the aminocaproic acid label say about other medicines?
The aminocaproic acid label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name aminocaproic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | contraindications | Aminocaproic acid must not be used in the presence of DIC without concomitant heparin. |
| Protamine | contraindications | Protamine paracoagulation test is positive in DIC; a precipitate forms when protamine sulfate is dropped into citrated plasma. |
Source: FDA drug label (Aminocaproic Acid), Hikma Pharmaceuticals USA Inc., effective January 8, 2024 (SPL set 7b8f0ddb-00fd-4c22-afae-afe636f95f3a), via openFDA; the full label on DailyMed
What do FAERS reports show for aminocaproic acid?
The FDA Adverse Event Reporting System holds 765 reports that list aminocaproic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 141 are coded as a death and 288 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antifibrinolytic agents
- the pharmacologic class, with prices and generics
- Aminocaproic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other