Sterile diluent: adverse event reports filed with FDA

3,221

reports as suspect product

0% of all reports · about 237 a year

600

reports, 12 months to June 2026

232 in the 12 months before

19.4%

marked serious by the reporter

42.7% across the class

1.3%

record death among outcomes, as reported

42 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 Sterile diluent reports recording the termmedian drug in insulin analog

1. No adverse eventno adverse event was reported61.1%1,967
2. Product storage errorthe product was stored wrongly22.6%728
3. Expired product administeredthe product was used past its expiry date12.9%416
4. Pyrexiafever5.6%179
5. Herpes zostershingles5.5%177
6. Incorrect product storagethe product was stored wrongly5.4%174
7. Product preparation error3.8%122
8. Incorrect route of product administrationthe product was given by the wrong route2.7%87
9. Injection site erythemaredness where the injection was given2.7%87
10. Rashskin rash2.4%78
11. Vaccination failure2.4%76
12. Product administered to patient of inappropriate age2.1%69
13. Inappropriate schedule of product administrationthe product was taken at the wrong times2%65
14. Product preparation issuea problem preparing the product1.9%62
15. Wrong product administered1.9%60
16. Injection site painpain where the injection was given1.6%51
17. Accidental exposure to product1.6%50
18. Incorrect route of drug administrationthe medicine was given by the wrong route1.6%50
19. Product storage issue1.5%48
20. Vomitingbeing sick1.5%47
21. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.4%46
22. Exposure during pregnancythe medicine was taken during pregnancy1.4%44
23. Incorrect dose administeredthe wrong dose was given1.3%43
24. Urticariahives1.3%42
25. Wrong drug administeredthe wrong medicine was given1.3%41
26. Extra dose administered1.2%40
27. Injection site swellingswelling where the injection was given1.2%40
28. Overdosea dose above the recommended amount1.2%40
29. Diarrhoealoose or frequent stools1.1%34
30. Drug administered to patient of inappropriate age1%33

Top 30 of 340 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. 87.2% 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 3,221 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sterile diluent 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 Sterile diluent as a suspect or interacting product; reports listing it only as a concomitant medication (104) 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.