Short answer: In the Gvoke label's adult trials of a 1 mg dose under the skin, nausea affected 30% of people within 12 hours, vomiting 16%, injection site swelling 7% and headache 5%. In children, nausea affected 45%, low blood sugar 39% and vomiting 19%. The label has no boxed warning; it lists pheochromocytoma and insulinoma as reasons not to use glucagon.
What Gvoke is approved for: Gvoke (HypoPen, PFS and Kit) is approved to treat severe low blood sugar (severe hypoglycemia) in adults and children aged 2 and older with diabetes, given under the skin (section 1.1). Gvoke VialDx is a separate IV form used as a diagnostic aid during radiology exams in adults, to briefly slow movement of the gut (section 1.2).
Source
GVOKE (glucagon) injection, for subcutaneous use, and GVOKE VialDx (glucagon) injection, for intravenous use, prescribing information, Patient Information and Instructions for Use. Xeris Pharmaceuticals. DailyMed, version published October 23, 2026. DailyMed setid 92385737-dbad-98c5-e053-2995a90a2805
No. The current Gvoke 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 Gvoke.
| Adverse reaction | GVOKE 1 mg dose (N=154) |
|---|---|
| Nausea | 30% |
| Vomiting | 16% |
| Injection site edema raised 1 mm or greater | 7% |
| Headache | 5% |
Reactions within 12 hours of a single 1 mg dose under the skin, in two crossover studies of adults with type 1 diabetes. The table has no comparator column.
| Adverse reaction | 2 to 6 years, 0.5 mg (N=7) | 6 to 12 years, 0.5 mg (N=13) | 12 to 18 years, 1 mg (N=11) | Total (N=31) |
|---|---|---|---|---|
| Nausea | 43% | 54% | 36% | 45% |
| Hypoglycemia | 29% | 54% | 27% | 39% |
| Vomiting | 14% | 23% | 18% | 19% |
| Headache | 0% | 15% | 0% | 7% |
| Abdominal pain | 0% | 8% | 0% | 3% |
| Hyperglycemia | 14% | 8% | 0% | 7% |
| Injection site discomfort | 0% | 8% | 0% | 3% |
| Injection site reaction | 0% | 0% | 9% | 3% |
| Urticaria | 0% | 8% | 0% | 3% |
Reactions within 12 hours, in one single-arm, open-label study.
| Adverse reaction | GVOKE VialDx 0.75 mg IV (N=83) |
|---|---|
| Nausea | 37.3% |
| Dysgeusia (change in taste) | 18.1% |
| Headache | 10.8% |
| Hot flush | 9.6% |
| Dizziness | 8.4% |
This is the IV diagnostic form (VialDx), studied in healthy volunteers, not the rescue injection.
Injection site pain was reported by 1% of adults given Gvoke. High blood pressure and fast heart rate have occurred with glucagon treatment.
Reported after approval of glucagon: necrolytic migratory erythema (a skin rash) with continuous glucagon infusion, and low blood sugar including hypoglycemic coma. People taking indomethacin may be more likely to have low blood sugar after glucagon.
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. Gvoke is not used by people with pheochromocytoma (an adrenal gland tumor) or insulinoma (a pancreas tumor), or who have had an allergic reaction to glucagon or its ingredients. VialDx is also not used as a diagnostic aid in people with glucagonoma.
Blood pressure spike with pheochromocytoma. Glucagon can make this adrenal tumor release hormones that raise blood pressure sharply.
Low blood sugar with insulinoma. In people with this pancreas tumor, glucagon can first raise blood sugar and then trigger too much insulin, causing low blood sugar. Glucose is given by mouth or vein if that happens.
Serious allergic reactions. Serious allergic reactions, including rash and in some cases anaphylactic shock with breathing trouble and low blood pressure, have been reported with glucagon. Gvoke is stopped and medical help sought right away.
May not work with low liver glycogen. People with low glycogen stores in the liver, such as with starvation, adrenal insufficiency or long-lasting low blood sugar, may not respond to Gvoke.
Necrolytic migratory erythema. A scaly, itchy, blistering rash has been reported after continuous glucagon infusion. Gvoke is not approved for continuous infusion.
High blood sugar with VialDx in diabetes. The IV diagnostic form can raise blood sugar in people with diabetes, so glucose is monitored.
Heart strain with VialDx in heart disease. The IV diagnostic form can raise heart oxygen demand, blood pressure and pulse, which may be life-threatening in people with heart disease; heart monitoring is recommended.
Low blood sugar with VialDx in glucagonoma. In people with a glucagon-producing tumor, the IV diagnostic form can cause secondary low blood sugar.
From the Patient Information that comes with Gvoke:
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.