Insulin glargine: adverse event reports filed with FDA

27,994

reports as suspect product

0.1% of all reports · about 1,244 a year

1,923

reports, 12 months to June 2026

2,658 in the 12 months before

42.8%

marked serious by the reporter

42.7% across the class

4.2%

record death among outcomes, as reported

1,178 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 glargine reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading22.7%6,350
2. Incorrect dose administeredthe wrong dose was given8.4%2,358
3. Visual impairmentreduced vision6.5%1,806
4. Accidental underdose5.4%1,507
5. Drug ineffectivethe medicine did not work as expected5.3%1,479
6. Blood glucose decreasedlow blood sugar reading5.3%1,477
7. Hypoglycaemialow blood sugar5.2%1,453
8. Injection site painpain where the injection was given4.5%1,261
9. Inappropriate schedule of product administrationthe product was taken at the wrong times4.1%1,150
10. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.6%998
11. Product dose omission issuea dose was missed3.2%896
12. Malaisegeneral feeling of being unwell2.6%735
13. Product storage errorthe product was stored wrongly2.6%719
14. Hyperglycaemiahigh blood sugar2.3%647
15. Blood glucose abnormal2.2%623
16. Cerebrovascular accidentstroke2.2%614
17. Falla fall2.1%591
18. Diabetes mellitus inadequate controldiabetes not well controlled2.1%583
19. Dizzinesslight-headedness or unsteadiness2%569
20. Product dose omissiona dose was missed1.9%539
21. Pain in extremitypain in an arm or leg1.9%527
22. Fatiguetiredness1.9%524
23. Dyspnoeashortness of breath1.8%507
24. Cataractclouding of the eye lens1.8%490
25. Underdoseless than the intended dose1.7%478
26. Astheniaweakness or lack of energy1.7%465
27. Nauseafeeling sick1.7%464
28. Memory impairmentmemory problems1.6%450
29. Headachehead pain1.6%449
30. Off label useused for a purpose or in a way not on the label1.6%445

Top 30 of 1,627 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. 78.6% 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 27,994 reports.

Drugs most often listed in the same reports

Other products listed in reports where Insulin glargine 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 glargine as a suspect or interacting product; reports listing it only as a concomitant medication (15,891) 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.