Humulin 70/30: adverse event reports filed with FDA

6,870

reports as suspect product

0% of all reports · about 305 a year

132

reports, 12 months to June 2026

192 in the 12 months before

49.7%

marked serious by the reporter

56.4% across the class

3.2%

record death among outcomes, as reported

219 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 Humulin 70/30 reports recording the termmedian drug in insulin

1. Blood glucose increasedraised blood sugar reading34.6%2,378
2. Blood glucose decreasedlow blood sugar reading10.9%749
3. Incorrect dose administeredthe wrong dose was given8.3%569
4. Drug ineffectivethe medicine did not work as expected7.8%534
5. Visual impairmentreduced vision6.4%438
6. Cataractclouding of the eye lens3.9%269
7. Malaisegeneral feeling of being unwell3.9%269
8. Visual acuity reducedreduced sharpness of vision3.8%260
9. Underdoseless than the intended dose3.7%252
10. Drug dose omissiona dose was missed3.3%226
11. Pharmaceutical product complaint3.3%226
12. Blood glucose abnormal3.3%225
13. Cerebrovascular accidentstroke3.2%219
14. Injection site painpain where the injection was given3.1%212
15. Falla fall3.1%211
16. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.9%202
17. Feeling abnormalfeeling odd or not right2.9%197
18. Hypoglycaemialow blood sugar2.8%190
19. Dizzinesslight-headedness or unsteadiness2.8%189
20. Weight decreasedweight loss2.5%172
21. Myocardial infarctionheart attack2.5%170
22. Weight increasedweight gain2.5%170
23. Memory impairmentmemory problems2.4%164
24. Hypertensionhigh blood pressure2.4%162
25. Blindnessloss of sight2.3%155
26. Blood glucose fluctuation2.3%155
27. Astheniaweakness or lack of energy2.2%150
28. Diabetes mellitus inadequate controldiabetes not well controlled2.1%144
29. Tremorshaking2.1%142
30. Cardiac disorder2%135

Top 30 of 665 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 9 drugs in the insulin 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 36,121 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. 79.5% 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 6,870 reports.

Drugs most often listed in the same reports

Other products listed in reports where Humulin 70/30 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 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 Humulin 70/30 as a suspect or interacting product; reports listing it only as a concomitant medication (1,632) 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.