Pharmacologic class (EPC) · 26 drug pages

Insulin analog: adverse event reports filed with FDA

289,293 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

289,293
reports across the class: 1.4% of all reports; 21,769
reports, 12 months to June 2026: 22,253 in the 12 months before; 42.7%
marked serious by the reporter: 57.4% across all reports; 26
drugs with a page: brand and generic names counted separately

Insulin analog is a pharmacologic class (an FDA Established Pharmacologic Class) with 26 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 289,293 adverse event reports received by FDA, 1.4% of the database, from January 2004 to June 2026.

21,769 reports arrived in the 12 months to June 2026, close to the 22,253 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 42.7% of the class's reports are marked serious, 3.5% record death among the outcomes and 18.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are blood glucose increased (25.3%), blood glucose decreased (6.2%) and drug ineffective (5.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
HumalogInsulin lispro	brand	71,174	2,312	34.4%	Blood glucose increased
Lantus SolostarInsulin glargine	brand	45,715	4,230	24.6%	Blood glucose increased
LantusInsulin glargine	brand	39,128	3,718	63.8%	Blood glucose increased
Insulin glargine	generic	27,994	1,923	42.8%	Blood glucose increased
ToujeoInsulin glargine	brand	15,491	1,332	24.7%	Blood glucose increased
NovologInsulin aspart	brand	14,477	1,576	61.8%	Blood glucose increased
LevemirInsulin detemir	brand	13,652	671	54.8%	Blood glucose increased
TresibaInsulin degludec	brand	10,373	1,263	55.1%	Blood glucose increased
Insulin lispro	generic	8,209	1,116	45.6%	Blood glucose increased
Humalog Mix75/25Insulin lispro	brand	8,139	140	23.8%	Blood glucose increased
Insulin	generic	8,135	522	88.9%	Hypoglycaemia
ApidraInsulin glulisine	brand	3,621	86	69.2%	Blood glucose increased
Insulin aspart	generic	3,232	553	88.6%	Hypoglycaemia
Sterile diluent	generic	3,221	600	19.4%	No adverse event
Humalog KwikpenInsulin lispro	brand	3,040	169	27.5%	Blood glucose increased
NovoLog Mix 70/30Insulin aspart	brand	2,101	230	65.5%	Blood glucose increased
SemgleeInsulin glargine-yfgn	brand	2,028	156	6.8%	Device mechanical issue
TOUJEO MaxInsulin glargine	brand	1,921	320	11.2%	Off label use
FiaspInsulin aspart injection	brand	1,569	245	60.5%	Blood glucose increased
Apidra SoloStarInsulin glulisine	brand	1,380	32	59.3%	Blood glucose increased
AdmelogInsulin lispro	brand	958	145	21.3%	Blood glucose increased
Lyumjev KwikpenInsulin lispro-aabc	brand	902	132	13.4%	Blood glucose increased
LyumjevInsulin lispro-aabc	brand	868	65	16.8%	Infusion site pain
Humalog Junior KwikpenInsulin lispro	brand	751	55	12.9%	Blood glucose increased
Insulin glulisine	generic	607	37	94.2%	Blood glucose increased
Insulin degludec	generic	607	141	90.3%	Stress

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Blood glucose increasedraised blood sugar reading25.3%73,160
Blood glucose decreasedlow blood sugar reading6.2%17,879
Drug ineffectivethe medicine did not work as expected5.3%15,228
Visual impairmentreduced vision4.8%13,807
Incorrect dose administeredthe wrong dose was given4.6%13,395
Hypoglycaemialow blood sugar4.5%13,006
Off label useused for a purpose or in a way not on the label4.1%11,958
Product storage errorthe product was stored wrongly4%11,587
Inappropriate schedule of product administrationthe product was taken at the wrong times3.5%10,232
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.6%7,619
Injection site painpain where the injection was given2.6%7,614
Malaisegeneral feeling of being unwell2.6%7,505
Blood glucose abnormal2.2%6,220
Hyperglycaemiahigh blood sugar2%5,782
Falla fall2%5,722
Drug dose omissiona dose was missed1.9%5,455
Dizzinesslight-headedness or unsteadiness1.9%5,426
Cerebrovascular accidentstroke1.9%5,391
Diabetes mellitus inadequate controldiabetes not well controlled1.8%5,272
Nauseafeeling sick1.7%4,972
Weight decreasedweight loss1.6%4,751
Cataractclouding of the eye lens1.6%4,615
Dyspnoeashortness of breath1.6%4,534
Weight increasedweight gain1.6%4,487
Wrong technique in product usage processthe product was used in the wrong way1.5%4,357

Solid bar: share of all class reports. Hollow bar: the median share across the 26 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3.5%10,266

Life-threatening2.1%5,973

Hospitalisation (initial or prolonged)18.6%53,860

Disability2%5,698

Congenital anomaly0.3%1,000

Other serious27.5%79,469

Not serious57.3%165,665

Patient age

Under 20.4%1,171

2 to 110.8%2,425

12 to 170.8%2,448

18 to 446.3%18,301

45 to 6420.1%58,212

65 to 7416%46,190

75 and over12.7%36,643

Age not given42.8%123,903

Who reported

Physician7.4%21,326

Pharmacist4.1%11,964

Other health professional8%23,225

Lawyer0%100

Consumer or non-health professional78.7%227,808

Not given1.7%4,870

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Insulin analog reports

Which drugs are in the Insulin analog class on this site?

Humalog, Lantus Solostar, Lantus, Insulin glargine, Toujeo and Novolog and 20 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

289,293 reports through June 2026, 21,769 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

blood glucose increased (25.3%), blood glucose decreased (6.2%), drug ineffective (5.3%), visual impairment (4.8%) and incorrect dose administered (4.6%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.