pharmacopeia
GET
/api/v1/drug/liraglutide

Boxed warning

RISK OF THYROID C-CELL TUMORS WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [ see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 ) ]. Liraglutide injection is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide injection and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide injection [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.

2D structure
(2S)-5-[[(5S)-5-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]propanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-5-oxopentanoyl]amino]propanoyl]amino]propanoyl]amino]-6-[[(2S)-1-[[(2S)-1-[[(2S,3S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-5-carbamimidamido-1-(carboxymethylamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-6-oxohexyl]amino]-2-(hexadecanoylamino)-5-oxopentanoic acid
SMILES CCCCCCCCCCCCCCCC(=O)N[C@@H](CCC(=O)NCCCC[C@@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC2=CNC3=CC=CC=C32)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H]([C@@H](C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](CC6=CN=CN6)N)C(=O)O
InChIKey YSDQQAXHVYUZIW-QCIJIYAXSA-N

Mechanism of action

Sourced from openFDA

Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7 to 37). GLP-1(7 to 37) represents <20% of total circulating endogenous GLP-1.

Glucagon-like Peptide-1 (GLP-1)

Indications

Sourced from openFDA
  • Liraglutide injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.ICD-10: E11.9

Contraindications

Sourced from openFDA
  • Liraglutide injection is contraindicated in patients with a: personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection.contraindicated

Dosage & administration

Sourced from openFDA

Adult Patients: Initiate at 0.6 mg injected subcutaneously once daily for one week then increase to 1.2 mg daily. If additional glycemic control is required, increase the dose to 1.8 mg daily after one week of treatment with the 1.2 mg daily dose. ( 2.1 ) Pediatric Patients: Initiate at 0.6 mg injected subcutaneously once daily for at least one week. If additional glycemic control is required increase the dose to 1.2 mg daily and if additional glycemic control is still required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. ( 2.1 ) Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles. ( 2.3 ) Inject liraglutide injection subcutaneously once-daily at any time of day, independently of meals, in the abdomen, thigh or upper arm. ( 2.3 ) When using liraglutide injection with insulin, administer as separate injections. Never mix. ( 2.3 ) 2.1 Recommended Dosage Adult Patients The recommended starting dosage of liraglutide injection is 0.6 mg injected subcutaneously once daily for one week. The 0.6 mg once daily dosage is intended to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] during initial titration and is not effective for glycemic control in adults. After one week at the 0.6 mg once daily dosage, increase the dosage to 1.2 mg injected subcutaneously once daily.

Warnings & precautions

Sourced from openFDA

Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide injection. Discontinue if pancreatitis is suspected. ( 5.2 ) Never Share a liraglutide injection Pen Between Patients, even if the needle is changed. ( 5.3 ) Hypoglycemia : Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with liraglutide injection regardless of insulin and/or metformin use. Reduction in the dose of insulin secretagogues or insulin may be necessary. ( 5.4 ) A cute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) S evere Gastrointestinal Adverse Reactions : Use has been associated with gastrointestinal adverse reactions, sometimes severe. Liraglutide injection is not recommended in patients with severe gastroparesis. ( 5.6 ) Hypersensitivity Reactions : Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue liraglutide injection and promptly seek medical advice. ( 5.7 ) Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation. ( 6.1 ) Immunogenicity-related events, including urticaria, were more common among liraglutide injection-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. ( 12.6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Use in specific populations

Sourced from openFDA

Pregnancy: Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 ) 8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide injection during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data) . The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes (Hemoglobin A 1C >7) is 6 to 10%. The major birth defect rate has been reported to be as high as 20 to 25% in women with a Hemoglobin A 1C >10. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 8 to 12 hours post dosing. The mean peak (C max ) and total (AUC) exposures of liraglutide were 35 ng/mL and 960 ng·h/mL, respectively, for a subcutaneous single dose of 0.6 mg.

Overdosage

Sourced from openFDA

Overdoses have been reported in clinical trials and post-marketing use of liraglutide injection. Observed effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdosage, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Initiate appropriate supportive treatment according to the patient's clinical signs and symptoms.

Approval history

Sourced from openFDA
  • Jan 25, 2010NDANDA022341Novo Nordisk Inc
  • Dec 23, 2014NDANDA206321Novo
  • Nov 21, 2016BLABLA208583Novo
  • Dec 23, 2024ANDAANDA215503Hikma
  • Apr 2, 2025ANDAANDA218115Nanjing King Friend
  • Jul 22, 2025ANDAANDA215421Lupin
  • Aug 27, 2025ANDAANDA214568Teva Pharms
  • Jan 14, 2026ANDAANDA217590Orbicular

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-02)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-03)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-20)Active
    Sponsor: Novo Nordisk, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-22)Active
    Sponsor: Novo Nordisk, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 0480-7250-46)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 71288-563-84)Active
    Sponsor: Meitheal Pharmaceuticals, Inc.
    Updated
  • Liraglutide, Injection, 6 mg/1 mL (NDC 71288-563-85)Active
    Sponsor: Meitheal Pharmaceuticals, Inc. · Reason: Other
    Updated
  • Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15)Active
    Sponsor: Novo Nordisk, Inc.
    Updated
  • Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-12)Active
    Sponsor: Novo Nordisk, Inc. · Reason: Delay in shipping of the drug
    Updated
  • Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-13)Active
    Sponsor: Novo Nordisk, Inc. · Reason: Delay in shipping of the drug
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
50,219 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea7,25014%
  2. 2Blood Glucose Increased4,0808.1%
  3. 3Vomiting3,5587.1%
  4. 4Diarrhoea3,4286.8%
  5. 5Pancreatitis2,3564.7%
  6. 6Decreased Appetite2,1504.3%
  7. 7Weight Decreased2,1484.3%
  8. 8Headache2,0424.1%
  9. 9Off Label Use1,8513.7%
  10. 10Fatigue1,6783.3%
  11. 11Drug Ineffective1,6023.2%
  12. 12Constipation1,5953.2%
  13. 13Dizziness1,5463.1%
  14. 14Abdominal Pain Upper1,4692.9%
  15. 15Malaise1,3732.7%

Literature

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Recent PubMed references pinned to Liraglutide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 511 ClinicalTrials.gov registrations naming Liraglutide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Liraglutide work?
Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7 to 37). GLP-1(7 to 37) represents <20% of total circulating endogenous GLP-1.
What is Liraglutide used for?
According to FDA labeling, Liraglutide carries indications including: Liraglutide injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Liraglutide?
Liraglutide is classified as Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 Receptor Agonist, Glucagon-like Peptide-1 (GLP-1) Agonists, Decreased Gastric Motility.
What are the brand names for Liraglutide?
Liraglutide is marketed under brand names including Saxenda, Victoza, Xultophy.
What are the contraindications for Liraglutide?
Liraglutide labeling lists contraindications including: Liraglutide injection is contraindicated in patients with a: personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection.. Always consult the full prescribing information and a clinician.
Note. Data for liraglutide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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