Prescription medicine
Dalteparin Brand names: Fragmin
Dalteparin (Fragmin) is a prescription medicine with an FDA approval on record since 1994. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the dalteparin FDA label on DailyMed (effective September 30, 2025, Pfizer Laboratories Div Pfizer Inc); the NDA 20287 record on Drugs@FDA; every dalteparin label on DailyMed.
Highlights of the record
FDA label of September 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SPINAL/EPIDURAL HEMATOMAS.
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
Use of indwelling epidural catheters
Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
A history of traumatic or repeated epidural or spinal punctures
A history of spinal deformity or spinal surgery
Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7) ]. WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageFRAGMIN is a low molecular weight heparin (LMWH) indicated for
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 )
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 )
Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the r
Forms and strengths
- 0.2ml
- 0.3ml
- 0.5ml
- 0.6ml
- 0.72ml
Injection.
On the market
- Earliest approval on file
- December 22, 1994 Fragmin, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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
- 10,517 through July 30, 2026
What is dalteparin used for?
From the label: indications and usageFRAGMIN is a low molecular weight heparin (LMWH) indicated for
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 )
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 )
Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. […]
Conditions named in the indications of dalteparin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anti-coagulant and Low Molecular Weight Heparin.
Source: FDA drug label (Fragmin), Pfizer Laboratories Div Pfizer Inc, effective September 30, 2025 (SPL set 23527b8b-9b28-4e6d-9751-33b143975ac7), via openFDA; the full label on DailyMed
Is there a generic for dalteparin (Fragmin)?
No generic dalteparin is approved (Drugs@FDA, October 8, 2026).
- 1994 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dalteparin label say about other medicines?
The dalteparin label names 1 other medicine in its interaction, contraindication or warning sections. 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 | Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. |
Source: FDA drug label (Fragmin), Pfizer Laboratories Div Pfizer Inc, effective September 30, 2025 (SPL set 23527b8b-9b28-4e6d-9751-33b143975ac7), via openFDA; the full label on DailyMed
What do FAERS reports show for dalteparin?
The FDA Adverse Event Reporting System holds 10,517 reports that list dalteparin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,287 are coded as a death and 5,467 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 else is labeled for the same conditions as dalteparin?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as dalteparin or labeled mainly for the same use (angina), the same class first. Angina lists all 21 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 (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Enoxaparin | Angina, Heart attack and coronary artery disease, Blood clots (DVT and PE) | 14 labelers | $6.45 per mL 100 mg/mL syringe | No current entry |
| Evolocumab | Angina, Heart attack and coronary artery disease | none listed | $281.96 per mL 140 mg/mL sureclick | No current entry |
| Alirocumab | Angina, Heart attack and coronary artery disease | none listed | $258.01 per mL 150 mg/mL pen | No current entry |
Every medicine labeled for the same conditions as dalteparin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dalteparin
- 3 medicines for the same use
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Dalteparin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other