Source: FDA label
| Molecular formula | C257H389N65O77S6 |
|---|---|
| Molecular weight | 5814 g/mol |
| Registered trials | 387 |
| PubChem CID | 16132438 |
| Drug class | Insulin Analog [EPC] |
| Brand names | ADMELOG |
Mechanism of Action
12.1 Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis.
Key takeaways
- Insulin lispro is a rapid-acting human insulin analog used to manage blood glucose in diabetes.
- It is approved for adult and pediatric patients under the brand name ADMELOG.
- More than 380 registered trials have studied insulin lispro, including phase 4 and phase 1 work.
- FAERS reports are dominated by blood glucose fluctuations and dosing errors rather than a single dominant side effect.
- It carries no boxed warning.
What insulin lispro is
Insulin lispro belongs to a class of medicines called insulin analogs, which are engineered versions of human insulin. It works the way natural insulin does: it helps muscle and fat tissue take up glucose from the blood while telling the liver to slow its own glucose output. It also curbs the breakdown of fat and protein and supports protein building, mirroring the body's normal hormonal signals after a meal.
What insulin lispro is approved for
Insulin lispro, marketed as ADMELOG, is approved to improve glycemic control in adults and children with diabetes mellitus. As a rapid-acting insulin, it is used alongside broader diabetes management rather than as a standalone therapy. The label carries no boxed warning.
What the evidence shows
Insulin lispro has been evaluated in 387 registered clinical trials. A completed phase 4 study looked at an insulin lispro mix in Asian patients with type 2 diabetes, reflecting real-world use after approval. A completed phase 1 trial compared two lispro formulations for bioequivalence, the kind of study used to confirm consistent drug performance.
Reported side effects
FAERS submissions for insulin lispro are, unsurprisingly for an insulin product, centered on glucose control itself. Blood glucose increased is the most frequently reported term, with 38,971 reports, followed by incorrect dose administered (9,346) and blood glucose decreased (8,902). Reports also describe drug ineffectiveness (8,309), visual impairment (5,539), nausea (4,932), malaise (4,013), and hypoglycaemia (3,860). These figures represent counts of submitted reports, not confirmed rates or proven causation, and they can reflect underlying disease as much as the drug itself.
FAQ
What is insulin lispro used for?
Insulin lispro is a rapid-acting insulin analog approved to improve blood glucose control in adults and children with diabetes mellitus. It is marketed under the brand name ADMELOG.
How does insulin lispro work?
It works like natural insulin by helping muscle and fat cells absorb glucose from the blood and by reducing glucose production in the liver. It also slows the breakdown of fat and protein while supporting protein synthesis.
Does insulin lispro have a boxed warning?
No, the insulin lispro label does not carry a boxed warning.
What side effects are most commonly reported with insulin lispro?
The most frequently reported issues involve blood glucose swings, both increases and decreases, along with dosing errors and occasional visual impairment or nausea. These are counts from adverse event reports, not confirmed rates, and do not establish that the drug caused each event.
How much clinical research exists on insulin lispro?
Insulin lispro has been studied in 387 registered clinical trials, spanning early bioequivalence work through phase 4 studies conducted after approval.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication.
Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: FDA label (ADMELOG) DailyMed ClinicalTrials.gov FDA FAERS PubChem CID 16132438
Updated 2026-08-03