Fragmin (dalteparin sodium) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Fragmin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Dalteparin sodium
Class: Anti-coagulant
Also reported as: Fragmin /01708302/, Fragmin Solution For Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 3,327 adverse event reports that name Fragmin. In these reports the drug is a suspect or interacting product.

In the same period, 4,719 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 220 reports in the 12 months to June 2026 and 194 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 220 (under 0.1%) name Fragmin. Reports from consumers or other non-health professionals were 18.4% of the reports that name Fragmin and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Fragmin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 61 reports that name Fragmin.
In January to March 2026, FDA received 60.
In April to June 2025, FDA received 61.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 422 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 3,322 of the 3,327 reports (99.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 422 terms.

Reaction terms in the reports that name Fragmin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,327 reports
Pulmonary embolisma blood clot in the lung	319	9.6%
Off label useused for a purpose or in a way not on the label	275	8.3%
Nauseafeeling sick	237	7.1%
Needle issuea problem with the needle	227	6.8%
Condition aggravatedthe condition being treated got worse	221	6.6%
General physical health deteriorationgeneral decline in health	209	6.3%
Multiple organ dysfunction syndromeseveral organs failing	207	6.2%
Abdominal painstomach or belly pain	203	6.1%
Thrombosis	193	5.8%
Vomitingbeing sick	191	5.7%
Dyspnoeashortness of breath	187	5.6%
Sepsisa severe body-wide response to infection	182	5.5%
Constipation	181	5.4%
Abdominal distensiona bloated abdomen	180	5.4%
Anaemialow red blood cells	180	5.4%
Stress	172	5.2%
Cardiogenic shockshock from the heart failing to pump	171	5.1%
Hyponatraemialow blood sodium	171	5.1%
Ascitesfluid in the abdomen	165	5%
Appendicitis	164	4.9%
Appendicolith	162	4.9%
Swelling	161	4.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	158	4.7%
Somnolencedrowsiness	152	4.6%
Drug ineffectivethe medicine did not work as expected	142	4.3%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	139	4.2%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	138	4.1%
Dry mouth	133	4%
Deaththe patient died; cause not stated by this term	132	4%
Blood phosphorus increased	128	3.8%
Diabetes mellitusdiabetes	128	3.8%
Myasthenia gravis	127	3.8%
Drug intolerancethe medicine was not tolerated	125	3.8%
Neuralgia	118	3.5%
Intentional product misusedeliberate use not as intended	117	3.5%
Bacterial infectiona bacterial infection	116	3.5%
Lower respiratory tract infectiona chest infection	116	3.5%
Blood cholesterol increasedraised cholesterol	112	3.4%
Hyperphosphataemia	112	3.4%
Sleep disordera sleep problem	112	3.4%
Blood uric acid increasedraised uric acid	111	3.3%
Device operational issue	111	3.3%
Incorrect route of product administrationthe product was given by the wrong route	110	3.3%
Hypophosphataemia	108	3.2%
Toxic epidermal necrolysisa severe skin reaction with peeling	107	3.2%
Product use in unapproved indicationused for a purpose not on the label	106	3.2%
Deep vein thrombosisa blood clot in a deep vein	103	3.1%
Painpain, site not specified	102	3.1%
Activated partial thromboplastin time prolonged	101	3%
Drug interactionan interaction between medicines	97	2.9%

Download all 422 terms of Fragmin (CSV)

The counts add to more than 3,327 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Dalteparin sodium with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dalteparin sodium	Generic name	1,298
Fragmin (this page)	Brand name	3,327

Sum of the separately reported names: 4,625. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Fragmin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	105	103	31	12	41	3	3	40	2
2005	114	112	27	22	56	4	0	48	2
2006	80	78	10	9	29	4	1	40	2
2007	111	110	24	10	34	5	0	63	1
2008	72	69	21	10	30	0	1	29	3
2009	100	99	39	7	42	2	0	44	1
2010	107	105	36	7	40	3	2	53	2
2011	101	99	35	9	45	1	2	50	2
2012	82	78	18	7	34	1	2	38	4
2013	111	89	25	7	30	4	3	51	22
2014	102	100	14	9	56	3	3	50	2
2015	118	114	32	13	56	1	0	57	4
2016	105	101	18	18	46	7	8	43	4
2017	126	122	31	8	47	11	8	65	4
2018	143	137	36	26	80	1	1	83	6
2019	160	154	30	22	78	1	0	94	6
2020	152	144	18	11	79	6	0	103	8
2021	274	141	35	32	69	5	0	100	133
2022	331	146	49	11	57	17	0	116	185
2023	262	177	70	54	103	54	4	150	85
2024	204	136	33	38	77	24	4	106	68
2025	204	140	48	47	100	35	30	88	64
2026	163	77	63	48	63	57	46	68	86

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Fragmin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Fragmin, by the year in which FDA received them
Year	Reports
2004	103
2005	111
2006	82
2007	112
2008	76
2009	102
2010	106
2011	103
2012	94
2013	111
2014	105
2015	119
2016	123
2017	125
2018	165
2019	181
2020	149
2021	318
2022	299
2023	238
2024	192
2025	191
2026	121

Reports that name Fragmin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Fragmin
Age	Reports	Share
Under 2	16	0.5%
2 to 11	3	0.1%
12 to 17	6	0.2%
18 to 44	378	11.4%
45 to 64	620	18.6%
65 to 74	501	15.1%
75 and over	753	22.6%
Age not given	1,050	31.6%

Sex of the patient in the reports that name Fragmin
Sex	Reports	Share
Female	1,489	44.8%
Male	1,198	36%
Unknown or not given	640	19.2%

Type of reporter in the reports that name Fragmin
Reporter	Reports	Share
Physician	884	26.6%
Pharmacist	595	17.9%
Other health professional	1,074	32.3%
Lawyer	15	0.5%
Consumer or non-health professional	611	18.4%
Not given	148	4.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 9.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Fragmin record
Indication as recorded (MedDRA)	Reports	Share
Thrombosis prophylaxis	455	13.7%
Pulmonary embolism	226	6.8%
Deep vein thrombosis	143	4.3%
Thrombosis	134	4%
Prophylaxis	111	3.3%
Anticoagulant therapy	72	2.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,327 reports.

Drugs in the same reports

Other drugs that the reports of Fragmin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	372
Allopurinol	235
Dextrose	212
Heparin sodium	247
Ipratropium bromide	252
Lansoprazole	290
Ondansetron	253
Phytonadione	238
Potassium chloride	289
Simvastatin	245

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Dalteparin sodium same ingredient
Heparin sodium same class
Clenpiq same class
Heparin Sodium in Dextrose same class
Bivalirudin same class
Potassium citrate same class
Foundayo next in the A to Z list
Fragmine next in the A to Z list
Fotivda next in the A to Z list
Framycetin Sulfate next in the A to Z list
Fotemustine next in the A to Z list
Fraxiparine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for FragminThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Fragmin: adverse event reports that FDA received. https://reportedreactions.com/drug/fragmin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Fragmin as a suspect or interacting product. The 4,719 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Fragmin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Fragmin?

No. It is a count of what people reported to FDA: 3,327 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (32.3%), physician (26.6%) and consumer or non-health professional (18.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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