Prescription medicine
Protamine
Protamine is a prescription medicine with an FDA approval on record since 1969. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the protamine FDA label on DailyMed (effective April 29, 2025, Fresenius Kabi USA, LLC); the NDA 6460 record on Drugs@FDA; every protamine label on DailyMed.
Highlights of the record
FDA label of April 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension. Risk factors include high dose or overdose, rapid administration (see WARNINGS and DOSAGE AND ADMINISTRATION ), repeated doses, previous administration of protamine, and current or previous use of protamine-containing drugs (NPH insulin, protamine zinc insulin, and certain beta-blockers). Allergy to fish, previous vasectomy, and severe left ventricular dysfunction and abnormal preoperative pulmonary hemodynamics also may be risk factors. In patients with any of these risk factors, the risk to benefit of administration of protamine sulfate should be carefully considered. Vasopressors and resuscitation equipment should be immediately available in case of a severe reaction to protamine. Protamine sulfate should not be given when bleeding occurs without prior heparin use.
Used for
From the label: indications and usageProtamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
Forms and strengths
- 10 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- August 13, 1969 Protamine Sulfate, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first November 5, 1986; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 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)
- No recall recorded
- FAERS reports
- 1,837 through July 30, 2026
What is protamine used for?
From the label: indications and usageProtamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
FDA pharmacologic class: Heparin Reversal Agent.
Source: FDA drug label (Protamine Sulfate), Fresenius Kabi USA, LLC, effective April 29, 2025 (SPL set c76876da-b9a8-45d0-9278-7df3288d3a06), via openFDA; the full label on DailyMed
Is there a generic for protamine?
The FDA approved the first generic protamine on November 5, 1986. 3 generic applications are approved; 1 of them carries 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 protamine from 2 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.
- 1969 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the protamine label say about other medicines?
The protamine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 7 other medicines name protamine. 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 | boxed warning | Protamine sulfate should not be given when bleeding occurs without prior heparin use. |
Other labels that name protamine
Source: FDA drug label (Protamine Sulfate), Fresenius Kabi USA, LLC, effective April 29, 2025 (SPL set c76876da-b9a8-45d0-9278-7df3288d3a06), via openFDA; the full label on DailyMed
What do FAERS reports show for protamine?
The FDA Adverse Event Reporting System holds 1,837 reports that list protamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 686 are coded as a death and 727 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?
- Protamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other