Generic name
Insulin: adverse event reports filed with FDA
8,135 reports list it as a suspect or interacting product, 2004–2026. Class: Insulin analog. Also reported as Insulin Nos, Insulin Injection, Insulin /00030501/.
- 8,135
- reports as suspect product
- 0% of all reports · about 362 a year
- 522
- reports, 12 months to June 2026
- 555 in the 12 months before
- 88.9%
- marked serious by the reporter
- 42.7% across the class
- 18.7%
- record death among outcomes, as reported
- 1,520 reports · not verified by FDA
Between January 2004 and June 2026, 8,135 adverse event reports received by FDA list insulin, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (66,805) are left out of every figure here.
In the 12 months to June 2026, 522 reports listed it, close to the 555 of 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 362 reports a year and 0% of the 20,646,523 reports in the database, and 2.8% 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.
Reporters most often recorded hypoglycaemia (12.5%), foetal exposure during pregnancy (9.4%) and drug ineffective (9.3%). A report can list several reactions, so shares add to more than 100%; 1,311 different terms appear across these reports. Hypoglycaemia is recorded in 12.5% of these reports, a larger share than in the median insulin analog drug (4%).
88.9% of the reports are marked serious by the reporter (42.7% across the class); 18.7% record death among the outcomes and 42% record hospitalisation, as reported. 39.6% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (25.7%). 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 reports recording the termmedian drug in insulin analog
- Hypoglycaemialow blood sugar12.5%1,019
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine9.4%767
- Drug ineffectivethe medicine did not work as expected9.3%755
- Completed suicidedeath by suicide7.5%612
- Premature babya baby born early6.5%531
- Toxicity to various agentspoisoning or toxic effect of one or more substances6.4%524
- Maternal exposure during pregnancythe mother took the medicine during pregnancy6%490
- Blood glucose increasedraised blood sugar reading5.8%470
- Off label useused for a purpose or in a way not on the label5%403
- Exposure during pregnancythe medicine was taken during pregnancy4.8%392
- Premature delivery4.4%358
- Blood glucose decreasedlow blood sugar reading4.4%354
- Drug interactionan interaction between medicines4%323
- Hypotensionlow blood pressure3.7%301
- Hyperglycaemiahigh blood sugar3.4%280
- Overdosea dose above the recommended amount3%247
- Condition aggravatedthe condition being treated got worse2.9%234
- Acute kidney injurysudden loss of kidney function2.8%229
- Diabetic ketoacidosisa serious complication of diabetes with acid build-up2.5%202
- Intentional overdosea deliberate overdose2.3%189
- Diabetes mellitus inadequate controldiabetes not well controlled2.3%188
- Weight decreasedweight loss2.3%186
- Dyspnoeashortness of breath2.3%185
- Low birth weight baby2.3%185
- Cardiac arrestthe heart stopped2.2%180
- Hyperkalaemiahigh blood potassium2.1%168
- Falla fall2.1%167
- Somnolencedrowsiness2%165
- Nauseafeeling sick2%164
- Vomitingbeing sick2%160
Top 30 of 1,311 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. 46.7% 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 | 1,373 | 16.9% |
| Type 2 diabetes mellitus | 764 | 9.4% |
| Type 1 diabetes mellitus | 308 | 3.8% |
| Gestational diabetes | 300 | 3.7% |
| Foetal exposure during pregnancy | 136 | 1.7% |
| Hyperkalaemia | 92 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 8,135 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Insulin reports |
|---|---|---|
| Metformin | 1,543 | 19% |
| Furosemide | 632 | 7.8% |
| Amlodipine | 580 | 7.1% |
| Aspirin | 575 | 7.1% |
| Methyldopa | 434 | 5.3% |
| Metformin hydrochloride | 426 | 5.2% |
| Omeprazole | 426 | 5.2% |
| Nifedipine | 371 | 4.6% |
| Dextrose | 320 | 3.9% |
| Gabapentin | 289 | 3.6% |
Other products listed in reports where Insulin 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 | Insulin analog | All reports |
|---|---|---|---|
| Reports as suspect product | 8,135 | 289,293 | 20,646,523 |
| Share of that pool | — | 2.8% | 0% |
| Reports, latest 12 months | 522 | — | 1,332,454 |
| Marked serious | 88.9% | 42.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 187 | 35 | 91 |
| Hospitalisation recorded, per 1,000 reports | 420 | 186 | 213 |
| Consumer-filed share | 20.9% | 78.7% | 45.8% |
| Top term, share of reports | Hypoglycaemia 12.5% | median 4% | 0.2% |
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% |
| 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% |
| NovoLog Mix 70/30 | brand | 2,101 | 230 | 65.5% |
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 reports
How many adverse event reports has FDA received for Insulin?
8,135 reports list Insulin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 522 of them arrived in the latest 12 months. Another 66,805 list it only as a concomitant medication.
What reactions are recorded in Insulin reports?
hypoglycaemia (12.5%), foetal exposure during pregnancy (9.4%), drug ineffective (9.3%), completed suicide (7.5%) and premature baby (6.5%). 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 was responsible.
How serious are the reports?
88.9% are marked serious by the reporter. Among the outcomes recorded, 18.7% of reports include death and 42% 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 (39.6%), physician (24.7%) and consumer or non-health professional (20.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Insulin rising?
522 reports in the 12 months to June 2026, close to the 555 of 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 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?
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 as a suspect or interacting product; reports listing it only as a concomitant medication (66,805) 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.