Humalog Mix75/25: adverse event reports filed with FDA

8,139

reports as suspect product

0% of all reports · about 472 a year

140

reports, 12 months to June 2026

185 in the 12 months before

23.8%

marked serious by the reporter

42.7% across the class

1.2%

record death among outcomes, as reported

97 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 Humalog Mix75/25 reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading31%2,523
2. Incorrect dose administeredthe wrong dose was given9.9%807
3. Blood glucose decreasedlow blood sugar reading7.3%591
4. Drug dispensing errora dispensing mistake6.7%544
5. Visual impairmentreduced vision6.6%537
6. Drug ineffectivethe medicine did not work as expected5.5%450
7. Drug dose omissiona dose was missed5%408
8. Underdoseless than the intended dose4.5%369
9. Wrong drug administeredthe wrong medicine was given4.4%357
10. Malaisegeneral feeling of being unwell3.2%264
11. Blood glucose abnormal3.2%263
12. Injection site painpain where the injection was given3.2%257
13. Cataractclouding of the eye lens2.9%239
14. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.8%228
15. Visual acuity reducedreduced sharpness of vision2.4%196
16. Wrong technique in product usage processthe product was used in the wrong way2.4%193
17. Dizzinesslight-headedness or unsteadiness2.2%175
18. Hypoglycaemialow blood sugar2.1%174
19. Accidental underdose2.1%168
20. Falla fall2.1%167
21. Feeling abnormalfeeling odd or not right2%165
22. Hypoacusisreduced hearing2%161
23. Memory impairmentmemory problems1.9%154
24. Incorrect product storagethe product was stored wrongly1.8%144
25. Intercepted drug dispensing error1.8%144
26. Tremorshaking1.7%135
27. Intercepted product selection error1.6%132
28. Arthritis1.6%131
29. Weight increasedweight gain1.6%131
30. Astheniaweakness or lack of energy1.5%122

Top 30 of 556 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. 89.8% 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 8,139 reports.

Drugs most often listed in the same reports

Other products listed in reports where Humalog Mix75/25 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 Humalog Mix75/25 as a suspect or interacting product; reports listing it only as a concomitant medication (290) 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.