Glucagon for Injection

The following serious adverse reactions are described below and elsewhere in the labeling:

• Hypertension in patients with Pheochromocytoma [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
• Hypoglycemia in Patients with Insulinoma and Glucagonoma [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
• Hyperglycemia in Patients with Diabetes Mellitus [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity and Allergic Reactions; generalized allergic reactions including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension [see WARNINGS AND PRECAUTIONS]

Adverse Reactions from Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in clinical trials of another drug and may not reflect the rates observed in practice.

In an open-label clinical study of Glucagon for Injection, 29 healthy volunteers received a single dose of 1 mg Glucagon for Injection intramuscularly. Table 1 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients.

Table 1: Adverse Reactions in Healthy Volunteers Who Received Glucagon for Injection, 1 mg Administered Intramuscularly

Adverse Reactions from the Literature and Other Clinical Studies

The following adverse reactions have been identified from the literature and clinical studies with the use of glucagon. Therefore, it is not possible to reliably estimate their frequency.

• Nausea and vomiting occurred with doses above 1 mg administered by rapid intravenous injection (within 1 to 2 seconds). Doses above 1 mg are not recommended for intravenous use [see DOSAGE AND ADMINISTRATION].
• Hypotension was reported up to 2 hours after administration in patients receiving glucagon as premedication for upper GI endoscopy procedures.
• A temporary increase in both blood pressure and pulse rate occurred following the administration of glucagon. Patients taking beta-blockers experienced a temporary increase in both pulse and blood pressure that was greater than normal [see DRUG INTERACTIONS].
• Other adverse reactions included hypoglycemia and hypoglycemic coma, as described in postmarketing reports. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see DRUG INTERACTIONS].

Read the entire FDA prescribing information for GlucaGon (Glucagon for Injection)