Short answer: Low blood sugar (hypoglycemia) is the most common Admelog side effect, as with all insulin. Severe low blood sugar affected 13.5% of people with type 1 diabetes over 52 weeks and 2.4% with type 2 over 26 weeks. In the type 1 trial, nasopharyngitis affected 13% and upper respiratory infection 6%; in type 2, no other reaction reached 5%. Admelog has no boxed warning.
What Admelog is approved for: Admelog is a rapid-acting mealtime insulin approved to improve blood sugar control in adults and children with diabetes (section 1).
Source
ADMELOG (insulin lispro) injection, for subcutaneous or intravenous use, prescribing information, Patient Information and Instructions for Use. Sanofi-Aventis U.S.. DailyMed, version published June 25, 2025. DailyMed setid 0691def8-4a7b-4de3-866f-a280989f47f1
No. The current Admelog label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Admelog.
| Adverse reaction | ADMELOG + insulin glargine, % (n=252) |
|---|---|
| Nasopharyngitis | 13% |
| Upper respiratory tract infection | 6% |
Admelog with insulin glargine 100 units/mL; the table has no comparator column. Mean exposure was 49 weeks. In the 26-week type 2 trial (n=253), no reaction other than low blood sugar occurred in 5% or more.
| Measure | Rate on the label |
|---|---|
| Severe hypoglycemia, type 1 diabetes, 52 weeks | 13.5% |
| Severe hypoglycemia, type 2 diabetes, 26 weeks | 2.4% |
| Infusion set occlusions, adults on a pump, two 4-week periods (n=25) | 24% |
| Anti-drug antibodies, type 1: positive at baseline / new or rising during treatment | 49.4% / 22.6% |
| Anti-drug antibodies, type 2: positive at baseline / new or rising during treatment | 26.4% / 18.8% |
Severe meant an event needing another person to give carbohydrate, glucagon or other resuscitative help.
In a 16-week study of children with type 1 diabetes on a pump, infusion site reactions with another insulin lispro 100 units/mL product occurred in 21%, mostly redness and site reactions.
Redness, swelling or itching at the injection site usually resolve in a few days to a few weeks, but sometimes Admelog has to be stopped. Severe whole-body allergy can occur. Local reactions and general muscle aches have been reported with injected metacresol, an ingredient in Admelog.
Rapid improvement in blood sugar has been linked to a temporary, reversible vision refraction change, worsening of diabetic retinopathy and acute painful nerve pain. Weight gain, swelling from sodium retention and skin thickening or thinning (lipodystrophy) can also occur.
Reported after approval of another insulin lispro product: other insulins given by mistake, and localized cutaneous amyloidosis (lumps under the skin) at injection sites, which has affected blood sugar control.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Admelog is not used during an episode of low blood sugar, or by people allergic to insulin lispro or any of its ingredients.
Never share a pen or syringe. A SoloStar pen is never shared, even if the needle is changed, and needles and syringes are never shared, because of the risk of passing on blood-borne infections.
Changes in insulin regimen. Changing insulin strength, maker, type, injection site or method can cause high or low blood sugar, so changes are made under close medical supervision with more glucose checks.
Low blood sugar. Hypoglycemia is the most common reaction to insulin. Severe episodes can cause seizures or death and can affect driving. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows.
Medication mix-ups. Mix-ups between insulin products have been reported, so the insulin label is checked before each injection.
Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Admelog is stopped if it does.
Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.
Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.
Insulin pump failure. A pump or infusion set malfunction can quickly lead to high blood sugar and ketoacidosis. Pump users are trained to give insulin by injection and keep backup insulin on hand.
From the Patient Information that comes with Admelog:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.