Prescription medicine

Milrinone First approved as Primacor

Milrinone (Primacor) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 13 generic labelers.

Generic listed

Check it at the source: the milrinone FDA label on DailyMed (effective June 13, 2026, Shandong New Time Pharmaceutical Co., Ltd.); the NDA 19436 record on Drugs@FDA; every milrinone label on DailyMed.

Highlights of the record

FDA label of June 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.

Forms and strengths

0.2 mg/ml
1 mg/ml

Injection (solution).

On the market

Earliest approval on file: December 31, 1987 Primacor, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 26 first May 28, 2002; 14 with a marketed status in Drugs@FDA
Labelers listed (NDC): 13 of which 13 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 4 since 2015 0 Class I among all firms' recalls; latest August 14, 2023; 3 more by firms not listed as its makers
FAERS reports: 271 through July 30, 2026

What is milrinone used for?

From the label: indications and usage
Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.

Conditions named in the indications of milrinone's FDA labels, with every medicine labeled for each:

Heart failure

From other milrinone labels
Heart failure: INDICATIONS AND USAGE Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.

FDA pharmacologic class: Phosphodiesterase 3 Inhibitor.

Source: FDA drug label (Milrinone Lactate), Shandong New Time Pharmaceutical Co., Ltd., effective June 13, 2026 (SPL set 0fdaee3c-2144-4ca7-9868-54d251f468c0), via openFDA; the full label on DailyMed

Is there a generic for milrinone (Primacor)?

The FDA approved the first generic milrinone on May 28, 2002. 26 generic applications are approved; 14 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 milrinone from 13 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.

1987 earliest approval on file
2002 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has milrinone been recalled?

The FDA's Enforcement Report lists 7 recalls naming milrinone since 2015: 0 Class I (the most serious), 6 Class II, 1 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of milrinone 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
August 14, 2023	Class III	Caplin Steriles Limited	Failed Impurities/Degradation Specifications
December 27, 2022	Class II	Sentara Infusion Services not a listed maker	Lack of sterility assurance
July 9, 2019	Class II	Pfizer Inc.	Lack of Assurance of Sterility: Bags have the potential to leak.
May 15, 2017	Class II	Baxter Healthcare Corporation	Lack of assurance of sterility: customer complaints received for the presence of leaks.
April 18, 2016	Class II	Baptist Health Medical Towers Pharmacy and Infusion Services not a listed maker	Lack of Sterility Assurance
November 10, 2015	Class II	Walgreens Infusion Services not a listed maker	Lack of Assurance of Sterility

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the milrinone label say about other medicines?

The milrinone label names no other medicine on this site. The labels of 2 other medicines name milrinone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name milrinone

Anagrelide

Check milrinone against other medicines

What do FAERS reports show for milrinone?

The FDA Adverse Event Reporting System holds 271 reports that list milrinone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 98 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.

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)89
Hypotension (named in the label)16
Renal Failure13
Cardiac Failure12
Dyspnoea11
Cardiac Arrest10
Off Label Use (a use or a product term, not a reaction)10
Ventricular Tachycardia (named in the label)10

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as milrinone?

3 other medicines are given the same way (intravenous) and in the same FDA class as milrinone or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Furosemide	Heart failure	13 labelers	$0.490 per mL 20 mg/2 mL vial	In shortage
Sodium nitroprusside	Heart failure	12 labelers	n/a	No current entry
Chlorothiazide	Heart failure	5 labelers	n/a	A presentation being discontinued

Every medicine labeled for the same conditions as milrinone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to milrinone: 3 medicines for the same use
Other phosphodiesterase 3 inhibitors: the pharmacologic class, with prices and generics
Milrinone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other