Is glucagon FDA-approved?

Yes. Glucagon is an approved drug, not a research chemical, and it has been approved for a long time — Drugs@FDA records the original Lilly glucagon application, NDA 012122, as approved on 14 November 1960. Twelve applications list glucagon or glucagon hydrochloride as an active ingredient. The ones currently recorded as marketed are NDA 212097 (Gvoke HypoPen, Gvoke PFS and Gvoke Kit, from Xeris), NDA 210134 (Baqsimi nasal powder, from Amphastar), NDA 201849 (Glucagon for Injection, from Fresenius Kabi) and four abbreviated applications from Mylan, Amphastar, Lupin and Cipla. Several are recorded as Discontinued, including Eli Lilly's two glucagon NDAs and Novo Nordisk's GlucaGen. A caution for anyone checking this themselves: querying the openFDA Drugs@FDA endpoint by generic name returns only seven of the twelve applications, because the openfda block is empty on five of them, including the 1960 approval. Query by active ingredient instead.

Is glucagon approved for weight loss or fat burning?

No. No FDA-approved glucagon label read for this record contains a weight, body composition or metabolic-enhancement indication. Every approved indication across the current labels is one of two things — treating severe hypoglycemia in patients with diabetes, or acting as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Worth separating two distinct things that share a word: glucagon-receptor agonism is one arm of several investigational multi-agonist obesity drugs, but those are different molecules with their own development programmes and their own regulatory status, and nothing about them transfers to the approved glucagon products. The clinical evidence behind the approved products is also specific to the approved use: the pivotal trials tested reversal of insulin-induced hypoglycaemia against another glucagon injection, and none of them studied weight or body composition. Note also that the approved rescue products are labeled for single emergency administration, and their labeling states they are not approved for continuous infusion.

Can any product labeled 'Glucagon for Injection' be used to treat severe hypoglycemia?

No, and this is the trap on this compound. Under one application number — NDA 201849, Fresenius Kabi — there are two presentations of Glucagon for Injection with different approved indications. One is approved for both severe hypoglycemia and diagnostic use. The other is approved only as a diagnostic aid, and its FDA-approved labeling carries an explicit Limitation of Use: 'Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.' The reason FDA gives is about packaging rather than pharmacology — the diagnostic presentation is not supplied with what someone would need to prepare and give it in an emergency. The generic name on the carton does not distinguish the two, so the indication section of the specific product's labeling is the only thing that answers the question.

Does glucagon always work for severe hypoglycemia?

No — FDA-approved labeling names in advance the circumstances in which it will not. The BAQSIMI label states: 'BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose.' The GVOKE label carries the same limitation for subcutaneous use. The mechanism explains it: glucagon raises blood glucose by activating hepatic glucagon receptors and stimulating glycogen breakdown, so a patient whose liver glycogen is already depleted has nothing for the drug to act on. Separately, the products are contraindicated in pheochromocytoma, because glucagon can stimulate catecholamine release from the tumour, and in insulinoma, where labeling records that an initial rise in blood glucose may be followed by exaggerated insulin release and hypoglycemia.

Are Baqsimi and Gvoke the same thing?

No. They are the same active ingredient in different products, approved under different applications, and their labeling differs in ways that matter at the point of use. BAQSIMI (NDA 210134, Amphastar) is a nasal powder, and its label indicates it 'for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes' — a hypoglycemia indication only. GVOKE (NDA 212097, Xeris) is a subcutaneous injection indicated from age two, and the same application also covers GVOKE VialDx, an intravenous presentation approved for a completely different purpose: use as a diagnostic aid during radiologic examinations. So the paediatric age floors differ, the routes differ, and only one of the two applications carries a diagnostic indication. Drugs@FDA also records the GVOKE VialDx presentation as Discontinued.

Is glucagon on FDA's 503A bulk drug substances list?

No. Glucagon appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026, verified by fetching the document and text-extracting it directly on 2 August 2026. That absence means something different from the absence of the compounds this site usually covers. BPC-157 and the other consumer peptides are absent because their nominations were withdrawn, and they remain unusable in 503A compounding. Glucagon was never in that process: the 503A nomination track exists for bulk substances that are neither the subject of a USP monograph nor a component of an FDA-approved drug, and glucagon is a component of several currently marketed approved drugs. Silence in the categories here is neither a permission nor a safety finding, and this record deliberately records no 503A category for glucagon rather than assert a status in a proceeding it was never part of.

Glucagon

Also sold as: Baqsimi, Gvoke, Gvoke HypoPen, Gvoke PFS, Gvoke Kit, Gvoke VialDx, GlucaGen, glucagon hydrochloride, glucagon (rDNA origin), G-Pen, LY900018

Glucagon is an FDA-approved drug as well as a human hormone, marketed in the United States under NDA 212097 (Gvoke and Gvoke VialDx, Xeris), NDA 210134 (Baqsimi nasal powder, Amphastar) and NDA 201849 (Glucagon for Injection, Fresenius Kabi), with the first glucagon application approved on 14 November 1960. Across those labels FDA has approved glucagon for exactly two things: treating severe hypoglycemia in patients with diabetes, and use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. No label read for this record approves glucagon for weight loss, body composition or metabolic enhancement. The products are not interchangeable — one presentation of Glucagon for Injection under NDA 201849 states in its own FDA-approved labeling that it 'is not indicated for the emergency treatment of hypoglycemia', and the approved paediatric age floor is two years for Gvoke and one year for Baqsimi. FDA-approved labeling also records limits on when glucagon works and when it must not be given: Baqsimi labeling states it 'is effective in treating hypoglycemia only if sufficient hepatic glycogen is present', and the products are contraindicated in pheochromocytoma and in insulinoma. Glucagon appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026 — an absence that reflects its status as a component of approved drugs rather than a withdrawn or rejected nomination.

Which molecule this is. A peptide hormone, and one of the few substances on this site that is simultaneously endogenous and an approved drug. FDA-approved labeling for GVOKE describes it verbatim as 'a single chain containing 29 amino acid residues', with 'a molecular weight of 3483', 'identical to human glucagon' and 'of synthetic origin produced by solid phase synthesis'. Two disambiguations matter when reading a carton. FIRST, ACTIVE MOIETY: Drugs@FDA records some glucagon products with the active ingredient 'GLUCAGON' (Gvoke, Baqsimi, the modern generic vials) and others with 'GLUCAGON HYDROCHLORIDE' expressed as equivalent base (Fresenius Kabi's NDA 201849, Novo Nordisk's GlucaGen, Lilly's original NDA 012122). SECOND, and more consequential, PRESENTATION: 'Glucagon for Injection' is not one product. Under a single application number, NDA 201849, Fresenius Kabi markets one presentation approved for both severe hypoglycemia and diagnostic use and another approved only as a diagnostic aid, whose own labeling states it is not indicated for the emergency treatment of hypoglycemia. The generic name on the vial does not identify which one you are holding.

FDA status

FDA-approved

FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.

FDA-approved, and approved for a long time — Drugs@FDA records the original Lilly glucagon application, NDA 012122, as approved on 1960-11-14. Approval is always for a specific indication and population, and glucagon's are unusually narrow relative to the breadth of the word: see the approval record below and the verbatim indications recorded under fdaFindings. COMPOUNDING STATUS IS DELIBERATELY OMITTED FROM THIS RECORD. Glucagon appears nowhere in FDA's 503A bulk drug substances list updated 2026-05-14 — verified by fetching and text-extracting the document on 2026-08-02, zero hits for 'glucagon' across all seven pages. That absence is recorded as a finding below rather than as a status, because asserting a 503A category would imply glucagon was part of a nomination proceeding it was never in. A 503A bulks nomination is a route for substances WITHOUT an approved product; glucagon has several.

GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025

“GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1) GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2)”

Checked against the source on 2 August 2026.

Evidence

Proven in humans

Efficacy established by adequate, well-controlled trials in humans.

ADMINISTRATION CHECK RUN, NOT ASSUMED — and on this compound the check is not a formality, because glucagon is the single worst offender for the endogenous-biomarker trap that reduces MOTS-c and TB-500 from an apparent five human trials to an actual zero. Glucagon is a hormone every human already secretes, and the literature contains a very large number of studies that MEASURE circulating glucagon as a metabolic readout without administering anything. None of those count. The four trials named here were opened individually on ClinicalTrials.gov on 2026-08-02 and every one records intervention type DRUG with glucagon given to participants. BAQSIMI (NDA 210134), section 14.1 of the label: Study 1 is NCT03339453 — Eli Lilly and Company, phase 1, randomised open-label 2-period crossover in adults with type 1 diabetes, enrolment 70 ACTUAL, status COMPLETED (primary completion 2017-12-17 ACTUAL), results posted; interventions 'Nasal Glucagon' (Administered nasally) and 'Intramuscular Glucagon' (Administered IM). Study 2 is NCT01994746 — same sponsor, phase 3, randomised open-label 2-period crossover, enrolment 77 ACTUAL, COMPLETED 2015-01, results posted. GVOKE (NDA 212097), section 14.1: Study A is NCT02656069 — Xeris Pharmaceuticals, phase 3, randomised crossover, TRIPLE masking, enrolment 80 ACTUAL, COMPLETED (primary completion 2017-08-14 ACTUAL), results posted. Study B is NCT03439072 — same sponsor, phase 3, randomised crossover, SINGLE masking, enrolment 81 ACTUAL, COMPLETED 2018-04-18, results posted. Both compared a glucagon injection against another glucagon injection. TWO DISCREPANCIES, recorded rather than smoothed over. (1) The BAQSIMI label states Study 2 'enrolled 83 patients' while the registry records enrolment 77 ACTUAL; the label's own efficacy analysis population is 80. We have not reconciled these and do not assert a single number. (2) The label describes GVOKE Study A as 'double-blinded' while the registry records TRIPLE masking. Neither discrepancy touches whether the drug was administered, which is what this tier turns on. SCOPE — the tier attaches to the approved indications and the approved products, and travels no further. Every trial above tested reversal of insulin-induced hypoglycaemia against an active glucagon comparator on a non-inferiority design. None of them is evidence about any other use of glucagon, and a non-inferiority result against another glucagon product is not a placebo-controlled demonstration of anything else.

Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia — ClinicalTrials.gov, 17 December 2017

“Nasal Glucagon | Administered nasally”

Checked against the source on 2 August 2026.

What FDA actually approved

Application: NDA 212097 (Gvoke HypoPen, Gvoke PFS, Gvoke Kit, Gvoke VialDx — Xeris); NDA 210134 (Baqsimi nasal powder — Amphastar); NDA 201849 (Glucagon for Injection — Fresenius Kabi); NDA 020928 and NDA 012122 (Glucagon — Lilly, both recorded Discontinued); NDA 020918 (GlucaGen — Novo Nordisk, recorded Discontinued); plus ANDA 204468 (Mylan), ANDA 208086 (Amphastar), ANDA 214457 (Lupin), ANDA 218813 (Cipla) — Gvoke, Gvoke VialDx, Baqsimi, GlucaGen, Glucagon
Approved indication: 1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes — GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes. 1.2 Diagnostic Aid in Adults — GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Verbatim from section 1 of the GVOKE label, which is the one document covering both of glucagon's approved indication types. THIS FIELD DOES NOT COVER THE OTHER APPLICATIONS: BAQSIMI (NDA 210134) and both Fresenius Kabi presentations under NDA 201849 carry DIFFERENT indication text, each recorded verbatim against its own label under fdaFindings. Read the differences, because they are the point. (1) The age floor is not the same across products — GVOKE is approved from age two, BAQSIMI from age one, and the Fresenius Kabi dual-indication label says 'pediatric and adult' without a numeric floor. (2) The diagnostic indication is a genuinely separate approval with a separate mechanism. GVOKE VialDx is labeled 'a gastrointestinal motility inhibitor' and is given intravenously in a radiology suite; it is not a rescue product. (3) `discontinued` is false because the franchise is marketed, but individual presentations are not. Drugs@FDA records GVOKE VialDx and one GVOKE PFS presentation as Discontinued, alongside the entirety of Lilly's NDA 012122 and NDA 020928 and Novo Nordisk's GlucaGen NDA 020918. The Lilly and GlucaGen entries carry the Federal Register annotation that the products were not discontinued or withdrawn for safety or effectiveness reasons — which, as this site says everywhere it appears, is the absence of an adverse finding and not an endorsement.

GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025Checked against the source on 2 August 2026.

What FDA found

FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.

Drugs@FDA records twelve applications with glucagon or glucagon hydrochloride as an active ingredient: NDA 012122 and NDA 020928 (Lilly), NDA 020918 (Novo Nordisk, GlucaGen), NDA 201849 (Fresenius Kabi), NDA 210134 (Amphastar, Baqsimi), NDA 212097 (Xeris, Gvoke), ANDA 071022 and ANDA 071023 (Quad), ANDA 204468 (Mylan), ANDA 208086 (Amphastar), ANDA 214457 (Lupin) and ANDA 218813 (Cipla). The earliest, NDA 012122, was approved on 1960-11-14.
RECORDED PRIMARILY AS A QUERY WARNING, because this record nearly published a wrong count. Searching the same endpoint on `openfda.generic_name:"glucagon"` returns SEVEN applications, not twelve: the openfda block is empty on NDA 012122, NDA 020918, NDA 020928, ANDA 071022 and ANDA 071023, so a generic_name query drops the original 1960 approval and GlucaGen entirely. The site has already published one false 'not in Drugs@FDA' claim generated exactly this way. Query by `products.active_ingredients.name` and cross-check. Marketing status as recorded on 2026-07-31: Prescription for Gvoke HypoPen (both presentations), Gvoke PFS (one presentation), Gvoke Kit, Baqsimi, both Fresenius Kabi presentations and all four modern ANDAs; Discontinued for Gvoke VialDx, one Gvoke PFS presentation, both GlucaGen presentations, both Lilly NDAs and both Quad ANDAs.
Drugs@FDA — applications with glucagon or glucagon hydrochloride as an active ingredient — FDA, 31 July 2026Checked against the source on 2 August 2026.
One presentation of Glucagon for Injection under NDA 201849 is approved ONLY as a diagnostic aid, and its FDA-approved labeling carries a Limitation of Use stating that it is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
The single most useful sentence on this record, and it is easy to miss because nothing about the product name signals it. Same application number as the dual-indication presentation, same sponsor, same words on the carton — 'Glucagon for Injection'. FDA's stated reason is not pharmacological, it is about PACKAGING: the presentation is not supplied with what a caregiver would need to reconstitute and inject it under emergency conditions. That is a distinction no amount of reading about the molecule would surface, and it is the kind of distinction that disappears entirely once a substance is discussed by its generic name alone.
Glucagon for Injection (diagnostic aid presentation, NDA 201849) — Highlights of Prescribing Information (SPL) — FDA, 1 April 2022
“Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use: Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.”
Checked against the source on 2 August 2026.
BAQSIMI (NDA 210134) is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. It carries no diagnostic indication.
Recorded verbatim because the age floor differs from GVOKE's and because BAQSIMI is the one non-injected glucagon product — a nasal powder, absorbed across the nasal mucosa. Note also a sponsor change the secondary corpus has largely not caught up with: Drugs@FDA records the sponsor of NDA 210134 as Amphastar Pharmaceuticals, and the current label directs adverse-event reporting to Amphastar, not to Eli Lilly, which developed the product and sponsored its pivotal trials.
BAQSIMI (glucagon) nasal powder — Highlights of Prescribing Information (SPL) — FDA, 19 June 2026
“BAQSIMI is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes.”
Checked against the source on 2 August 2026.
The dual-indication presentation of Glucagon for Injection under NDA 201849 is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes, and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
The counterpart to the Limitation-of-Use label above, recorded so that the contrast is carried by two sourced labels rather than by one label and an assertion. Both are NDA 201849. Both are Fresenius Kabi. Both are 'Glucagon for Injection'. Only this one is approved for the emergency use most people assume the name implies. Note this label states no numeric paediatric age floor, where GVOKE's is two years and BAQSIMI's is one.
Glucagon for Injection (severe hypoglycemia and diagnostic aid presentation, NDA 201849) — Highlights of Prescribing Information (SPL) — FDA, 31 March 2025
“Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2)”
Checked against the source on 2 August 2026.
Glucagon appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 2026-05-14.
Recorded to close a misreading, not to assert a status — which is why this record carries no compoundingStatus field at all. Verified by fetching the document with a browser user-agent and text-extracting it locally on 2026-08-02: zero hits for 'glucagon' across all seven pages. This absence means something entirely different from BPC-157's absence. BPC-157 was nominated and left Category 2 when its nominators withdrew. Glucagon was never in that system: the 503A nomination track exists for bulk substances that are neither the subject of a USP monograph nor a component of an FDA-approved drug, and glucagon is a component of several. Categorical silence here is neither permission nor a safety finding, and it is not a gap in FDA's evaluation.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.
FDA-approved labeling for GVOKE states that hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect, and describes glucagon's extrahepatic effects as relaxation of the smooth muscle of the stomach, duodenum, small bowel and colon.
Both approved indications fall out of these two sentences, which is why the label's mechanism section is worth quoting in full. The hepatic action is the rescue indication; the extrahepatic smooth-muscle action is the radiology indication. The first sentence is also the direct source of the efficacy limitation recorded under safety signals: a patient with depleted hepatic glycogen has nothing for the drug to act on.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.”
Checked against the source on 2 August 2026.

Documented safety signals

Labeled lack of efficacy in patients with decreased hepatic glycogen. FDA-approved labeling for BAQSIMI states it is effective in treating hypoglycemia only if sufficient hepatic glycogen is present, and that patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for it to be effective. The GVOKE label carries the same limitation for subcutaneous use.
A labeled failure mode, not a side effect, and the populations it names are exactly the ones most likely to be hypoglycaemic in the first place. The label's instruction in those conditions is to give glucose instead. This is the clearest case on the site of an approved drug whose label states in advance the circumstances in which it will not work.
BAQSIMI (glucagon) nasal powder — Highlights of Prescribing Information (SPL) — FDA, 19 June 2026
“BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose.”
Checked against the source on 2 August 2026.
Contraindicated in pheochromocytoma, because of the risk of a substantial increase in blood pressure from catecholamine release; contraindicated in insulinoma, because of the risk of hypoglycemia; and contraindicated in patients with prior hypersensitivity reaction to glucagon or to the product's excipients. GVOKE VialDx used as a diagnostic aid is additionally contraindicated in glucagonoma.
Two of these are paradoxical and worth stating plainly. In insulinoma the label records that glucagon administration may produce an initial rise in blood glucose but may then stimulate exaggerated insulin release and cause hypoglycemia — a hyperglycaemic agent producing the condition it is given to reverse. In glucagonoma the diagnostic use may cause secondary hypoglycemia. These are screening questions a prescriber asks, and the identical contraindications appear on the BAQSIMI label.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“GVOKE and GVOKE VialDx are contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure … Insulinoma because of the risk of hypoglycemia … Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. … GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia”
Checked against the source on 2 August 2026.
Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash and, in some cases, anaphylactic shock with breathing difficulties and hypotension.
Recorded because 'it is a hormone your body already makes' is the standard reassurance attached to endogenous compounds across this market, and it does not follow. The same warning appears verbatim on the BAQSIMI label. Endogenous identity is not a safety argument: insulin is endogenous too.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension.”
Checked against the source on 2 August 2026.
Necrolytic migratory erythema, a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. FDA approved labeling states GVOKE and GVOKE VialDx are not approved for continuous infusion.
The one labeled signal attached to a mode of use that is outside the approval. The approved products are single-administration rescue or a single diagnostic administration; the reported rash follows continuous infusion, which the label expressly states is not an approved use of these products. Anyone reasoning from 'glucagon is well characterised in humans' toward sustained or repeated exposure is reasoning past the evidence base recorded here, all of which is single-administration.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE and GVOKE VialDx are not approved for continuous infusion.”
Checked against the source on 2 August 2026.
Labeled warnings specific to intravenous diagnostic use of GVOKE VialDx include hyperglycemia in patients with diabetes mellitus, and increases in myocardial oxygen demand, blood pressure and pulse rate in patients with cardiac disease, for whom cardiac monitoring is recommended.
Route- and indication-specific, and recorded separately for that reason: these warnings attach to the intravenous diagnostic presentation, not to the subcutaneous rescue presentations. Note the direction of the first one — the product given to raise blood glucose in an emergency is warned, in its diagnostic role, for raising blood glucose too much in the same patient population.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus: GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. … Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease: GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate. Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid”
Checked against the source on 2 August 2026.
The most common adverse reactions reported at an incidence of 10% or greater in BAQSIMI trials were nausea, vomiting, headache, upper respiratory tract irritation (rhinorrhea, nasal discomfort, nasal congestion, cough and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.
Reproduced because the nasal route is frequently described as the gentler option and the label does not support that framing. In the pooled adult trials the label reports nausea in 26 percent, headache in 18 percent and vomiting in 15 percent of BAQSIMI recipients; among solicited symptoms, 59 percent reported an increase in watery eyes and 43 percent in nasal congestion. These are percentages of participants reporting a reaction, not amounts of anything.
BAQSIMI (glucagon) nasal powder — Highlights of Prescribing Information (SPL) — FDA, 19 June 2026
“Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, itchy nose, throat and eyes.”
Checked against the source on 2 August 2026.

Questions people actually ask

Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.

Is glucagon FDA-approved?: Yes. Glucagon is an approved drug, not a research chemical, and it has been approved for a long time — Drugs@FDA records the original Lilly glucagon application, NDA 012122, as approved on 14 November 1960. Twelve applications list glucagon or glucagon hydrochloride as an active ingredient. The ones currently recorded as marketed are NDA 212097 (Gvoke HypoPen, Gvoke PFS and Gvoke Kit, from Xeris), NDA 210134 (Baqsimi nasal powder, from Amphastar), NDA 201849 (Glucagon for Injection, from Fresenius Kabi) and four abbreviated applications from Mylan, Amphastar, Lupin and Cipla. Several are recorded as Discontinued, including Eli Lilly's two glucagon NDAs and Novo Nordisk's GlucaGen. A caution for anyone checking this themselves: querying the openFDA Drugs@FDA endpoint by generic name returns only seven of the twelve applications, because the openfda block is empty on five of them, including the 1960 approval. Query by active ingredient instead.
Drugs@FDA — applications with glucagon or glucagon hydrochloride as an active ingredient — FDA, 31 July 2026Checked against the source on 2 August 2026.
What is glucagon actually approved to treat?: Two things, and they are less alike than they sound. The first is emergency treatment of severe hypoglycemia in patients with diabetes. The second is diagnostic: FDA has approved glucagon as a gastrointestinal motility inhibitor, given during radiologic examinations to temporarily stop the gut moving so it can be imaged. The GVOKE label states both: 'GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes' and 'GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.' Both fall directly out of the label's mechanism section, which states that glucagon raises blood glucose by activating hepatic glucagon receptors and that its extrahepatic effects include relaxation of the smooth muscle of the stomach, duodenum, small bowel and colon. Baqsimi carries only the hypoglycemia indication; the Fresenius Kabi presentations under NDA 201849 carry one or both depending on the presentation.
GVOKE (glucagon) injection and GVOKE VialDx (glucagon) injection — Highlights of Prescribing Information (SPL) — FDA, 23 December 2025
“1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes. 1.2 Diagnostic Aid in Adults GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.”
Checked against the source on 2 August 2026.
Is glucagon approved for weight loss or fat burning?: No. No FDA-approved glucagon label read for this record contains a weight, body composition or metabolic-enhancement indication. Every approved indication across the current labels is one of two things — treating severe hypoglycemia in patients with diabetes, or acting as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Worth separating two distinct things that share a word: glucagon-receptor agonism is one arm of several investigational multi-agonist obesity drugs, but those are different molecules with their own development programmes and their own regulatory status, and nothing about them transfers to the approved glucagon products. The clinical evidence behind the approved products is also specific to the approved use: the pivotal trials tested reversal of insulin-induced hypoglycaemia against another glucagon injection, and none of them studied weight or body composition. Note also that the approved rescue products are labeled for single emergency administration, and their labeling states they are not approved for continuous infusion.
Glucagon for Injection (severe hypoglycemia and diagnostic aid presentation, NDA 201849) — Highlights of Prescribing Information (SPL) — FDA, 31 March 2025
“Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2)”
Checked against the source on 2 August 2026.
Can any product labeled 'Glucagon for Injection' be used to treat severe hypoglycemia?: No, and this is the trap on this compound. Under one application number — NDA 201849, Fresenius Kabi — there are two presentations of Glucagon for Injection with different approved indications. One is approved for both severe hypoglycemia and diagnostic use. The other is approved only as a diagnostic aid, and its FDA-approved labeling carries an explicit Limitation of Use: 'Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.' The reason FDA gives is about packaging rather than pharmacology — the diagnostic presentation is not supplied with what someone would need to prepare and give it in an emergency. The generic name on the carton does not distinguish the two, so the indication section of the specific product's labeling is the only thing that answers the question.
Glucagon for Injection (diagnostic aid presentation, NDA 201849) — Highlights of Prescribing Information (SPL) — FDA, 1 April 2022
“Limitations of Use: Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.”
Checked against the source on 2 August 2026.
Does glucagon always work for severe hypoglycemia?: No — FDA-approved labeling names in advance the circumstances in which it will not. The BAQSIMI label states: 'BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose.' The GVOKE label carries the same limitation for subcutaneous use. The mechanism explains it: glucagon raises blood glucose by activating hepatic glucagon receptors and stimulating glycogen breakdown, so a patient whose liver glycogen is already depleted has nothing for the drug to act on. Separately, the products are contraindicated in pheochromocytoma, because glucagon can stimulate catecholamine release from the tumour, and in insulinoma, where labeling records that an initial rise in blood glucose may be followed by exaggerated insulin release and hypoglycemia.
BAQSIMI (glucagon) nasal powder — Highlights of Prescribing Information (SPL) — FDA, 19 June 2026
“BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose.”
Checked against the source on 2 August 2026.
Are Baqsimi and Gvoke the same thing?: No. They are the same active ingredient in different products, approved under different applications, and their labeling differs in ways that matter at the point of use. BAQSIMI (NDA 210134, Amphastar) is a nasal powder, and its label indicates it 'for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes' — a hypoglycemia indication only. GVOKE (NDA 212097, Xeris) is a subcutaneous injection indicated from age two, and the same application also covers GVOKE VialDx, an intravenous presentation approved for a completely different purpose: use as a diagnostic aid during radiologic examinations. So the paediatric age floors differ, the routes differ, and only one of the two applications carries a diagnostic indication. Drugs@FDA also records the GVOKE VialDx presentation as Discontinued.
BAQSIMI (glucagon) nasal powder — Highlights of Prescribing Information (SPL) — FDA, 19 June 2026
“BAQSIMI is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes.”
Checked against the source on 2 August 2026.
Is glucagon on FDA's 503A bulk drug substances list?: No. Glucagon appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026, verified by fetching the document and text-extracting it directly on 2 August 2026. That absence means something different from the absence of the compounds this site usually covers. BPC-157 and the other consumer peptides are absent because their nominations were withdrawn, and they remain unusable in 503A compounding. Glucagon was never in that process: the 503A nomination track exists for bulk substances that are neither the subject of a USP monograph nor a component of an FDA-approved drug, and glucagon is a component of several currently marketed approved drugs. Silence in the categories here is neither a permission nor a safety finding, and this record deliberately records no 503A category for glucagon rather than assert a status in a proceeding it was never part of.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.