What the label lists and what reports show
Insulin lispro side effects
Insulin lispro's FDA label: “The most frequently reported infusion site-related reactions were infusion site erythema and infusion site reaction.” FAERS holds 139,157 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (39,314 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the insulin lispro FDA label on DailyMed (effective June 4, 2025, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ADMELOG?ADMELOG may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness headache shakiness irritability or mood changes sweating blurred vision fast heartbeat hunger confusion slurred speech anxiety serious allergic reactions (whole body reaction). Get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body a fast heartbeat sweating trouble breathing feel faint low potassium in your blood (hypokalemia). heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with ADMELOG may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. […]
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective June 4, 2025 (SPL set 0691def8-4a7b-4de3-866f-a280989f47f1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported infusion site-related reactions were infusion site erythema and infusion site reaction.
Table 1: Adverse Reactions That Occurred in ≥5% in Patients with Type 1 Diabetes Mellitus
This table is printed in the Insulin Lispro label published by Eli Lilly and Company of June 17, 2025; the label quoted above does not print one.
| Reaction | Insulin Lispro (%) (n=81) | Regular human insulin (%) (n=86) |
|---|---|---|
| Flu syndrome | 34.6 | 32.6 |
| Pharyngitis | 33.3 | 33.7 |
| Rhinitis | 24.7 | 29.1 |
| Headache | 29.6 | 22.1 |
| Pain | 19.8 | 16.3 |
| Cough increased | 17.3 | 17.4 |
| Infection | 13.6 | 20.9 |
| Nausea | 6.2 | 15.1 |
| Accidental injury | 8.6 | 11.6 |
| Surgical procedure | 6.2 | 14.0 |
| Fever | 6.2 | 11.6 |
| Abdominal pain | 7.4 | 8.1 |
| Asthenia | 7.4 | 8.1 |
| Bronchitis | 7.4 | 7.0 |
| Diarrhea | 8.6 | 5.8 |
| Dysmenorrhea | 6.2 | 7.0 |
| Myalgia | 7.4 | 5.8 |
| Urinary tract infection | 6.2 | 4.7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with Subcutaneous Injections of ADMELOG Two clinical trials with ADMELOG were conducted: one in patients with type 1 diabetes and one in patients with type 2 diabetes [see Clinical Studies (14) ]. The data in Table 1 reflect the exposure of 252 patients with type 1 diabetes to ADMELOG with mean exposure duration of 49 weeks. The type 1 diabetes population had the following characteristics: Mean age was 43 years and mean duration of diabetes was 20 years. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective June 4, 2025 (SPL set 0691def8-4a7b-4de3-866f-a280989f47f1), via openFDA; the full label on DailyMed
What do FAERS reports show?
139,157 reports list insulin lispro among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,059 are coded as a death and 34,351 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Insulin lispro: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions