Insulin aspart: adverse event reports filed with FDA

3,232

reports as suspect product

0% of all reports · about 145 a year

553

reports, 12 months to June 2026

506 in the 12 months before

88.6%

marked serious by the reporter

42.7% across the class

18.2%

record death among outcomes, as reported

588 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 Insulin aspart reports recording the termmedian drug in insulin analog

1. Hypoglycaemialow blood sugar12.2%395
2. Blood glucose increasedraised blood sugar reading11%356
3. Vomitingbeing sick10.1%327
4. Dyspnoeashortness of breath10.1%326
5. Condition aggravatedthe condition being treated got worse9.8%317
6. Nauseafeeling sick9.1%293
7. Off label useused for a purpose or in a way not on the label8.8%286
8. Abdominal painstomach or belly pain8.8%285
9. Stressstress8.4%273
10. Abdominal distensiona bloated abdomen7.4%239
11. General physical health deteriorationgeneral decline in health7.2%233
12. Hyponatraemialow blood sodium7.2%233
13. Multiple organ dysfunction syndromeseveral organs failing7.2%233
14. Sepsisa severe body-wide response to infection7.1%230
15. Ascitesfluid in the abdomen7%227
16. Constipationconstipation6.9%223
17. Appendicitis6.9%222
18. Appendicolith6.7%218
19. Cardiogenic shockshock from the heart failing to pump6.7%216
20. Asthmaasthma6.5%210
21. Thrombosis6.3%204
22. Anxietyanxiety6.2%200
23. Drug ineffectivethe medicine did not work as expected6.2%199
24. Ventricular fibrillationa chaotic rhythm from the lower heart chambers6.1%197
25. Pulmonary embolisma blood clot in the lung6%193
26. Wheezingwheezing5.6%182
27. Somnolencedrowsiness5.4%175
28. Sleep disordera sleep problem5.2%167
29. Therapeutic product effect incomplete5%162
30. Dry mouthdry mouth4.9%157

Top 30 of 700 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 26 drugs in the insulin analog 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 289,293 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. 30.8% 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 3,232 reports.

Drugs most often listed in the same reports

Other products listed in reports where Insulin aspart 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 insulin analog 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 Insulin aspart as a suspect or interacting product; reports listing it only as a concomitant medication (6,602) 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.