Zegalogue Side Effects: FDA Label Numbers vs Placebo
[Side effects · Zegalogue]

Zegalogue side effects

dasiglucagon injection · single-dose rescue injection under the skin, 0.6 mg autoinjector or prefilled syringe · Label checked

Short answer: In the Zegalogue label's adult placebo-controlled trials, reactions within 12 hours of a dose were nausea (57% vs 4% on placebo), vomiting (25% vs 2%), headache (11% vs 4%), diarrhea (5% vs 0%) and injection site pain (2% vs 0%). In children, nausea affected 65% and vomiting 50%. There is no boxed warning; pheochromocytoma and insulinoma are reasons not to use it.

What Zegalogue is approved for: Zegalogue is an antihypoglycemic agent approved to treat severe low blood sugar (severe hypoglycemia) in adults and children aged 6 years and above with diabetes (section 1).

Source
ZEGALOGUE (dasiglucagon) injection, for subcutaneous use, prescribing information, Patient Information and Instructions For Use. Novo Nordisk. DailyMed, version published June 17, 2026. DailyMed setid 14704879-872c-4967-8779-04a3bbdfb4e6

Does Zegalogue have a boxed warning?

No. The current Zegalogue label has no boxed warning.

What are the most common Zegalogue 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 Zegalogue.

Table 1. Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Adult Patients within 12 hours of Treatment in 2 Placebo-Controlled Trials [Section 6.1]
Adverse reaction typePlacebo (N=53) % of PatientsDasiglucagon (N=116) % of Patients
Nausea4%57%
Vomiting2%25%
Headache4%11%
Diarrhea0%5%
Injection site pain0%2%

116 adults with type 1 diabetes, mean age 40.

Table 2. Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Pediatric Patients within 12 hours of Treatment in a Placebo-Controlled Trial [Section 6.1]
Adverse reaction typePlacebo (N=11) %Dasiglucagon Age 6-11 years (N=8) %Dasiglucagon Age 12-17 years (N=12) %Dasiglucagon All (N=20) %
Nausea0%25%92%65%
Vomiting0%25%67%50%
Headache0%0%17%10%
Injection site pain0%0%8%5%

20 children with type 1 diabetes: 8 aged 7 to 11 and 12 aged 12 to 17.

Other numbers in the Adverse Reactions section

  • Section 6.1

    Other reactions within 12 hours of a dose included high blood pressure, low blood pressure, slow heart rate, near-fainting, palpitations and feeling unwell on standing.

  • Section 6.2

    4 of 498 people (under 1%) developed antibodies to dasiglucagon. One had antibodies that briefly neutralized it and also reacted with natural glucagon; no safety or efficacy concerns were seen.

  • Section 7

    People on beta-blockers may get a brief rise in pulse and blood pressure. With indomethacin, Zegalogue may not raise blood sugar or may even lower it. Zegalogue may increase the blood-thinning effect of warfarin.

What serious risks does the Zegalogue 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 5.1

    Blood pressure spike with pheochromocytoma. Glucagon products can make this adrenal tumor release hormones that raise blood pressure sharply. Zegalogue is not used by people with pheochromocytoma.

  • Section 5.2

    Low blood sugar with insulinoma. In people with this pancreas tumor, Zegalogue can trigger too much insulin and cause low blood sugar. If that happens, glucose is given by mouth or vein.

  • Section 5.3

    Allergic reactions. Allergic reactions have been reported with glucagon products, including widespread rash and, in some cases, anaphylactic shock with breathing trouble and low blood pressure.

  • Section 5.4

    May not work with low liver glycogen. Zegalogue works only if the liver has enough stored glycogen. People who are starving, have adrenal insufficiency or long-lasting low blood sugar may not respond and are treated with glucose.

  • Section 16.2

    Latex. The inside of the gray cap on the autoinjector and the gray needle cover on the prefilled syringe contain dry natural rubber (from latex).

  • Section 4

    Who should not use it. People with pheochromocytoma or insulinoma.

When does the label say to call your doctor?

From the Patient Information that comes with Zegalogue:

  • After Zegalogue is given, the caregiver calls for emergency medical help right away.
  • A serious allergic reaction, such as rash, difficulty breathing or low blood pressure: call your healthcare provider or get medical help right away.
  • Each time you use Zegalogue: tell your healthcare provider, who may need to change the dose of your other diabetes medicines.

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 Zegalogue?+
Nausea. Within 12 hours of a dose it affected 57% of adults vs 4% on placebo, and 65% of children. Vomiting affected 25% of adults and 50% of children (section 6.1, Tables 1 and 2).
Does Zegalogue have a boxed warning?+
No. The Zegalogue label has no boxed warning. Its warnings cover pheochromocytoma, insulinoma, allergic reactions and low liver glycogen (section 5).
Who should not use Zegalogue?+
People with pheochromocytoma, an adrenal gland tumor, or insulinoma, a pancreas tumor (section 4).
Are teenagers more likely to get nausea from Zegalogue?+
In the children's trial, nausea was 92% in ages 12 to 17 vs 25% in ages 6 to 11, and vomiting 67% vs 25% (section 6.1, Table 2).
Does Zegalogue contain latex?+
The inside of the gray cap on the autoinjector and the gray needle cover on the prefilled syringe contain dry natural rubber, a derivative of latex (section 16.2).