Novolin 70/30 Side Effects: FDA Label | Dose Track
[Side effects · Novolin 70/30]

Novolin 70/30 side effects

insulin isophane human and insulin human injectable suspension 70%/30% · premixed human insulin injection under the skin, usually twice daily; 10 mL vial or FlexPen · Label checked

Short answer: Low blood sugar (hypoglycemia) is the most common Novolin 70/30 side effect, as with all insulin. The label has no trial table with percentages; it lists reactions without rates: 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. Novolin 70/30 has no boxed warning.

What Novolin 70/30 is approved for: Novolin 70/30 is a premixed human insulin, 70% intermediate-acting NPH and 30% short-acting regular insulin. It is approved to improve blood sugar control in adults and children with diabetes. Its fixed proportions do not allow separate basal and mealtime dose changes (section 1).

Source
NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use, prescribing information and Patient Information. Novo Nordisk. DailyMed, version published September 29, 2026. DailyMed setid 508a2763-3cb7-4be5-9e53-544e84cd9b1f

Does Novolin 70/30 have a boxed warning?

No. The current Novolin 70/30 label has no boxed warning.

What are the most common Novolin 70/30 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 Novolin 70/30.

Listed in section 6, without percentages [Section 6]
ReactionWhat the label says
HypoglycemiaThe most commonly observed adverse reaction in Novolin 70/30
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
Metacresol reactionsLocal reactions and general muscle aches have been reported with metacresol, 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 Novolin 70/30
ImmunogenicityAnti-insulin antibodies may form; the rate with Novolin 70/30 is unknown

The label gives no rates and no placebo or comparator column for Novolin 70/30.

Other numbers in the Adverse Reactions section

  • Section 12.2

    The label calls Novolin 70/30 an intermediate-acting insulin with up to 24 hours duration of action. Under the skin, its glucose-lowering effect begins about 30 minutes after the dose, and timing can vary a lot between people and in the same person.

  • Patient Information

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

What serious risks does the Novolin 70/30 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. Novolin 70/30 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 FlexPen or syringe. A FlexPen 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 Novolin 70/30 and other insulins 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, with signs such as whole-body rash, trouble breathing, wheezing, low blood pressure, fast heartbeat or sweating. Novolin 70/30 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 dose-related fluid retention that may lead to or worsen heart failure. Stopping or lowering the TZD is considered if heart failure develops.

When does the label say to call your doctor?

From the Patient Information that comes with Novolin 70/30:

  • Severe low blood sugar needing hospital or emergency room care: get emergency medical help, and tell the hospital staff the units of Novolin 70/30 your healthcare provider prescribed.
  • Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness or confusion: get emergency medical help.
  • 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.
  • New or worse symptoms of heart failure while taking a TZD with Novolin 70/30, 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 Novolin 70/30?+
Low blood sugar (hypoglycemia), the most commonly observed reaction (sections 5.3 and 6). The Patient Information also lists allergic and injection site reactions, skin pits or thickening, weight gain and swelling.
Does the Novolin 70/30 label give side-effect percentages?+
No. Section 6 lists reactions without rates. The label has no clinical-trial table for Novolin 70/30.
Does Novolin 70/30 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 Novolin 70/30 last?+
The label says it starts lowering glucose about 30 minutes after the dose and has up to 24 hours duration of action, varying between people (section 12.2).
Does Novolin 70/30 cause weight gain?+
It can. The label says weight gain can occur with insulins including Novolin 70/30, attributed to insulin's anabolic effects and less sugar lost in the urine (section 6).