Humalog Mix75/25 Side Effects: FDA Label | Dose Track
[Side effects · Humalog Mix75/25]

Humalog Mix75/25 side effects

insulin lispro protamine and insulin lispro injectable suspension 75%/25% · premixed injection under the skin, usually twice daily; 10 mL vial or KwikPen · Label checked

Short answer: Low blood sugar (hypoglycemia) is the most common Humalog Mix75/25 side effect, as with all insulin. The label has no trial table with percentages; it lists reactions reported in use: redness, swelling or itching at the injection site, rare severe allergy, low potassium, skin pits or thickening, lumps under the skin, swelling and weight gain. Humalog Mix75/25 has no boxed warning.

What Humalog Mix75/25 is approved for: Humalog Mix75/25 is a premixed insulin approved to improve blood sugar control in adults with diabetes. Its fixed proportions do not allow separate basal and mealtime dose changes (section 1).

Source
HUMALOG Mix75/25 (insulin lispro protamine and insulin lispro) injectable suspension, for subcutaneous use, prescribing information and Patient Information. Eli Lilly and Company. DailyMed, version published August 10, 2026. DailyMed setid c73da51a-1899-45ad-b6cf-9c52c36a25dd

Does Humalog Mix75/25 have a boxed warning?

No. The current Humalog Mix75/25 label has no boxed warning.

What are the most common Humalog Mix75/25 side effects?

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 Humalog Mix75/25.

Listed in section 6, without percentages [Section 6]
ReactionWhat the label says
HypoglycemiaThe most commonly observed adverse reaction with Humalog Mix75/25
Injection site reactionsRedness, swelling or itching at the site, usually gone in a few days to a few weeks, sometimes needing the insulin to be stopped
Meta-cresol reactionsLocal reactions and general muscle aches have been reported with meta-cresol, an inactive ingredient
HypersensitivitySevere, life-threatening whole-body allergy, including anaphylaxis
HypokalemiaInsulin shifts potassium into cells, possibly causing low potassium
LipodystrophyLipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue)
Localized cutaneous amyloidosisLumps at the injection site; injecting into them has raised blood sugar, and a sudden switch to an unaffected site has lowered it
Peripheral edemaSodium retention and swelling, particularly if poor control is improved by more intensive insulin therapy
Weight gainAttributed to the anabolic effects of insulin and less sugar lost in the urine
Starting or tightening controlTemporary change in eye focus, worsening diabetic eye disease and acute painful nerve symptoms
Medication errorsOther insulins given by mistake in place of Humalog Mix75/25
ImmunogenicityAnti-insulin antibodies may form; the rate with Humalog Mix75/25 is unknown

The label gives no rates and no placebo or comparator column for Humalog Mix75/25.

Other numbers in the Adverse Reactions section

  • Section 12.2

    In healthy subjects given 0.3 unit/kg, the median maximum effect came at about 2 hours (range 1-6 hours), and glucose lowering was detectable for a median of 22 hours (range 13 to 22 hours), the end of the study. The label says its duration of activity is similar to Humulin 70/30, and that timing varies between people.

  • Patient Information

    The Patient Information lists the most common side effects as low blood sugar, injection site reactions, skin thickening or pits at the injection site, weight gain, swelling in the hands or feet, itching and rash.

What serious risks does the Humalog Mix75/25 label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 4

    Who should not use it. Humalog Mix75/25 is not used during an episode of low blood sugar, or by people who have had allergic reactions to it or any of its inactive ingredients.

  • Section 5.1

    Never share a pen or syringe. A KwikPen is never shared, even if the needle is changed, and vial users never share needles or syringes, because of the risk of passing on blood-borne infections.

  • Section 5.2

    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. In type 2 diabetes, other diabetes medicines may need adjusting.

  • Section 5.3

    Low blood sugar. Hypoglycemia is the most common reaction to all insulins. Severe episodes can cause seizures, unconsciousness or death and can affect driving. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows. Kidney or liver problems can raise the risk.

  • Section 5.4

    Medication mix-ups. Mix-ups between insulin products have been reported, so the insulin label is checked before each injection.

  • Section 5.5

    Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Humalog Mix75/25 is stopped if it does.

  • Section 5.6

    Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.

  • Section 5.7

    Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.

When does the label say to call your doctor?

From the Patient Information that comes with Humalog Mix75/25:

  • Signs of a severe allergic reaction, such as a rash over your whole body, trouble breathing, a fast heartbeat or sweating: get medical help right away.
  • Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness or confusion: get emergency medical help.
  • New or worse symptoms of heart failure while taking a TZD with Humalog Mix75/25, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain: tell your healthcare provider.

How do I keep track of side effects in Dose Track?

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.

Side effects for similar medicines

Frequently asked questions

What is the most common side effect of Humalog Mix75/25?+
Low blood sugar (hypoglycemia), the most commonly observed reaction (sections 5.3 and 6). The Patient Information also lists injection site reactions, skin pits or thickening, weight gain, swelling, itching and rash.
Does the Humalog Mix75/25 label give side-effect percentages?+
No. Section 6 lists reactions without rates. The label has no clinical-trial table for Humalog Mix75/25.
Does Humalog Mix75/25 have a boxed warning?+
No. The label has no boxed warning. Its warnings cover sharing pens or syringes, regimen changes, low blood sugar, mix-ups, allergic reactions, low potassium and heart failure with TZDs (section 5).
How long does Humalog Mix75/25 last?+
In healthy subjects, the maximum effect came at about 2 hours and glucose lowering was detectable for a median of 22 hours. The label says timing varies between people (section 12.2).
Does Humalog Mix75/25 cause weight gain?+
It can. The label says weight gain can occur with insulins including Humalog Mix75/25, attributed to insulin's anabolic effects and less sugar lost in the urine (section 6).