Apidra SoloStar: adverse event reports filed with FDA

1,380

reports as suspect product

0% of all reports · about 83 a year

32

reports, 12 months to June 2026

53 in the 12 months before

59.3%

marked serious by the reporter

42.7% across the class

2%

record death among outcomes, as reported

28 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 Apidra SoloStar reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading25%345
2. Hyperglycaemiahigh blood sugar8%110
3. Hypoglycaemialow blood sugar7.8%107
4. Drug ineffectivethe medicine did not work as expected6.5%90
5. Blood glucose decreasedlow blood sugar reading6.2%86
6. Visual impairmentreduced vision5.8%80
7. Malaisegeneral feeling of being unwell4.6%63
8. Wrong drug administeredthe wrong medicine was given4.4%61
9. Device malfunctionthe device did not work properly4%55
10. Blood glucose abnormal3.9%54
11. Product storage errorthe product was stored wrongly3.6%50
12. Product quality issuea problem with the product itself3.5%48
13. Dizzinesslight-headedness or unsteadiness3.1%43
14. Injection site painpain where the injection was given2.9%40
15. Diabetes mellitus inadequate controldiabetes not well controlled2.8%39
16. Feeling abnormalfeeling odd or not right2.6%36
17. Headachehead pain2.5%35
18. Device issuea problem with the device2.5%34
19. Expired product administeredthe product was used past its expiry date2.5%34
20. Cerebrovascular accidentstroke2.3%32
21. Product use issuea problem in how the product was used2.3%32
22. Drug administration errora mistake in giving the medicine2.2%31
23. Pruritusitching2.2%30
24. Tremorshaking2.2%30
25. Drug dose omissiona dose was missed2.1%29
26. Dyspnoeashortness of breath2.1%29
27. Gait disturbancedifficulty walking2.1%29
28. Painpain, site not specified2.1%29
29. Vomitingbeing sick2.1%29
30. Condition aggravatedthe condition being treated got worse2%28

Top 30 of 260 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. 64.9% 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 1,380 reports.

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 Apidra SoloStar as a suspect or interacting product; reports listing it only as a concomitant medication (338) 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.