Generic name
Insulin degludec: adverse event reports filed with FDA
607 reports list it as a suspect or interacting product, 2014–2026. Class: Insulin analog.
- 607
- reports as suspect product
- 0% of all reports · about 50 a year
- 141
- reports, 12 months to June 2026
- 105 in the 12 months before
- 90.3%
- marked serious by the reporter
- 42.7% across the class
- 40.5%
- record death among outcomes, as reported
- 246 reports · not verified by FDA
Between May 2014 and June 2026, 607 adverse event reports received by FDA list insulin degludec, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,076) are left out of every figure here.
In the 12 months to June 2026, 141 reports listed it, up 34% from 105 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 50 reports a year and 0% of the 20,646,523 reports in the database, and 0.2% of the reports for the insulin analog class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are stress (36.2%), vomiting (33.8%) and nausea (33.4%). A report can list several reactions, so shares add to more than 100%; 241 different terms appear across these reports. Stress is recorded in 36.2% of these reports, a larger share than in the median insulin analog drug (0.6%).
90.3% of the reports are marked serious by the reporter (42.7% across the class); 40.5% record death among the outcomes and 47.1% record hospitalisation, as reported. 52.6% of the reports came from other health professionals, and the largest patient age group is 75 and over (44%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 degludec reports recording the termmedian drug in insulin analog
- Stressstress36.2%220
- Vomitingbeing sick33.8%205
- Nauseafeeling sick33.4%203
- Ascitesfluid in the abdomen33.3%202
- General physical health deteriorationgeneral decline in health33.3%202
- Appendicitis33.1%201
- Appendicolith32.9%200
- Hyponatraemialow blood sodium32.9%200
- Abdominal distensiona bloated abdomen32.8%199
- Multiple organ dysfunction syndromeseveral organs failing32.6%198
- Cardiogenic shockshock from the heart failing to pump32.5%197
- Abdominal painstomach or belly pain32.3%196
- Sepsisa severe body-wide response to infection32.1%195
- Constipationconstipation31.6%192
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers28.3%172
- Off label useused for a purpose or in a way not on the label27.7%168
- Condition aggravatedthe condition being treated got worse25.9%157
- Blood phosphorus increased22.9%139
- Somnolencedrowsiness21.9%133
- Dry mouthdry mouth21.4%130
- Dyspnoeashortness of breath18.6%113
- Blood cholesterol increasedraised cholesterol18.1%110
- Myasthenia gravis17.3%105
- Blood uric acid increasedraised uric acid17.1%104
- Diabetes mellitusdiabetes16.8%102
- Anaemialow red blood cells16.6%101
- Bacterial infectiona bacterial infection16.6%101
- Intentional product misusedeliberate use not as intended16.6%101
- Thrombosis16.6%101
- Drug hypersensitivityan allergic-type reaction to a medicine16.5%100
Top 30 of 241 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 28.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Diabetes mellitus | 206 | 33.9% |
| Type 2 diabetes mellitus | 94 | 15.5% |
| Type 1 diabetes mellitus | 42 | 6.9% |
| Suicide attempt | 4 | 0.7% |
| Diabetes mellitus inadequate control | 3 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 607 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Insulin degludec reports |
|---|---|---|
| Insulin aspart | 297 | 48.9% |
| Gabapentin | 248 | 40.9% |
| Acetaminophen | 238 | 39.2% |
| Ipratropium bromide | 235 | 38.7% |
| Allopurinol | 230 | 37.9% |
| Melatonin | 226 | 37.2% |
| Calcitriol | 222 | 36.6% |
| Ondansetron | 220 | 36.2% |
| Metronidazole | 219 | 36.1% |
| Lansoprazole | 217 | 35.7% |
Other products listed in reports where Insulin degludec 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
| Measure | Insulin degludec | Insulin analog | All reports |
|---|---|---|---|
| Reports as suspect product | 607 | 289,293 | 20,646,523 |
| Share of that pool | — | 0.2% | 0% |
| Reports, latest 12 months | 141 | — | 1,332,454 |
| Marked serious | 90.3% | 42.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 405 | 35 | 91 |
| Hospitalisation recorded, per 1,000 reports | 471 | 186 | 213 |
| Consumer-filed share | 22.4% | 78.7% | 45.8% |
| Top term, share of reports | Stress 36.2% | median 0.6% | 0.3% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Humalog | brand | 71,174 | 2,312 | 34.4% |
| Lantus Solostar | brand | 45,715 | 4,230 | 24.6% |
| Lantus | brand | 39,128 | 3,718 | 63.8% |
| Insulin glargine | generic | 27,994 | 1,923 | 42.8% |
| Toujeo | brand | 15,491 | 1,332 | 24.7% |
| Novolog | brand | 14,477 | 1,576 | 61.8% |
| Levemir | brand | 13,652 | 671 | 54.8% |
| Tresiba | brand | 10,373 | 1,263 | 55.1% |
| Insulin lispro | generic | 8,209 | 1,116 | 45.6% |
| Humalog Mix75/25 | brand | 8,139 | 140 | 23.8% |
| Insulin | generic | 8,135 | 522 | 88.9% |
| Apidra | brand | 3,621 | 86 | 69.2% |
| Insulin aspart | generic | 3,232 | 553 | 88.6% |
| Sterile diluent | generic | 3,221 | 600 | 19.4% |
| Humalog Kwikpen | brand | 3,040 | 169 | 27.5% |
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.
Questions about Insulin degludec reports
How many adverse event reports has FDA received for Insulin degludec?
607 reports list Insulin degludec as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 141 of them arrived in the latest 12 months. Another 1,076 list it only as a concomitant medication.
What reactions are recorded in Insulin degludec reports?
stress (36.2%), vomiting (33.8%), nausea (33.4%), ascites (33.3%) and general physical health deterioration (33.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Insulin degludec was responsible.
How serious are the reports?
90.3% are marked serious by the reporter. Among the outcomes recorded, 40.5% of reports include death and 47.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (52.6%), consumer or non-health professional (22.4%) and physician (20.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Insulin degludec rising?
141 reports in the 12 months to June 2026, up 34% from 105 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Insulin degludec was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Insulin degludec?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 degludec as a suspect or interacting product; reports listing it only as a concomitant medication (1,076) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.