Dalteparin sodium: adverse event reports filed with FDA

1,298

reports as suspect product

0% of all reports · about 58 a year

63

reports, 12 months to June 2026

59 in the 12 months before

95.5%

marked serious by the reporter

55.7% across the class

37.8%

record death among outcomes, as reported

490 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 Dalteparin sodium reports recording the termmedian drug in anti-coagulant

1. Nauseafeeling sick16.9%220
2. Abdominal painstomach or belly pain16.6%215
3. Multiple organ dysfunction syndromeseveral organs failing15.9%207
4. Vomitingbeing sick15.9%207
5. Off label useused for a purpose or in a way not on the label15.9%206
6. Ascitesfluid in the abdomen15.8%205
7. Sepsisa severe body-wide response to infection15.6%202
8. Constipationconstipation15.5%201
9. General physical health deteriorationgeneral decline in health15.5%201
10. Appendicitis15.3%198
11. Hyponatraemialow blood sodium15.3%198
12. Abdominal distensiona bloated abdomen15.2%197
13. Appendicolith15.1%196
14. Cardiogenic shockshock from the heart failing to pump14.9%193
15. Stressstress14.6%189
16. Ventricular fibrillationa chaotic rhythm from the lower heart chambers13.1%170
17. Condition aggravatedthe condition being treated got worse11%143
18. Somnolencedrowsiness10.8%140
19. Blood phosphorus increased10.4%135
20. Anaemialow red blood cells10.2%133
21. Dry mouthdry mouth9.8%127
22. Pulmonary embolisma blood clot in the lung9.6%125
23. Drug hypersensitivityan allergic-type reaction to a medicine8.9%116
24. Dyspnoeashortness of breath8.7%113
25. Blood cholesterol increasedraised cholesterol8.3%108
26. Incorrect route of product administrationthe product was given by the wrong route8.1%105
27. Myasthenia gravis8%104
28. Blood uric acid increasedraised uric acid7.9%103
29. Thrombosis7.9%102
30. Bacterial infectiona bacterial infection7.7%100

Top 30 of 393 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. 7.8% 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 1,298 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dalteparin sodium 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 Dalteparin sodium as a suspect or interacting product; reports listing it only as a concomitant medication (1,495) 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.