Fragmin: adverse event reports filed with FDA

3,327

reports as suspect product

0% of all reports · about 148 a year

220

reports, 12 months to June 2026

194 in the 12 months before

79.1%

marked serious by the reporter

55.7% across the class

22.3%

record death among outcomes, as reported

743 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Fragmin reports recording the termmedian drug in anti-coagulant

1. Pulmonary embolisma blood clot in the lung9.6%319
2. Off label useused for a purpose or in a way not on the label8.3%275
3. Nauseafeeling sick7.1%237
4. Needle issuea problem with the needle6.8%227
5. Condition aggravatedthe condition being treated got worse6.6%221
6. General physical health deteriorationgeneral decline in health6.3%209
7. Multiple organ dysfunction syndromeseveral organs failing6.2%207
8. Abdominal painstomach or belly pain6.1%203
9. Thrombosis5.8%193
10. Vomitingbeing sick5.7%191
11. Dyspnoeashortness of breath5.6%187
12. Sepsisa severe body-wide response to infection5.5%182
13. Constipationconstipation5.4%181
14. Abdominal distensiona bloated abdomen5.4%180
15. Anaemialow red blood cells5.4%180
16. Stressstress5.2%172
17. Cardiogenic shockshock from the heart failing to pump5.1%171
18. Hyponatraemialow blood sodium5.1%171
19. Ascitesfluid in the abdomen5%165
20. Appendicitis4.9%164
21. Appendicolith4.9%162
22. Swellingswelling4.8%161
23. Drug hypersensitivityan allergic-type reaction to a medicine4.7%158
24. Somnolencedrowsiness4.6%152
25. Drug ineffectivethe medicine did not work as expected4.3%142
26. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease4.2%139
27. Ventricular fibrillationa chaotic rhythm from the lower heart chambers4.1%138
28. Dry mouthdry mouth4%133
29. Deaththe patient died; cause not stated by this term4%132
30. Blood phosphorus increased3.8%128

Top 30 of 818 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 10 drugs in the anti-coagulant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 28,971 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 9.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,327 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fragmin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the anti-coagulant class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Fragmin as a suspect or interacting product; reports listing it only as a concomitant medication (4,719) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.