This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
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 ) and 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 of MTC with 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 warnin...
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other lir...
Liraglutide injection is contraindicated in: Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1) ]. Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide injection [see Warnings and Precautions (5.7) ] . Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. ( 4 ) Hypersensitivity to liraglutide or any excipients in liraglutide injection. ( 4 )
Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide injection. Discontinue if pancreatitis is suspected. ( 5.2 ) Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.3 ) Hypoglycemia: Can occur in adults when liraglutide injection is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in liraglutide injection-treated pediatric patients. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.4 ) Heart Rate Increase: Monitor heart rate at regular intervals. ( 5.5 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.6 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. Liraglutide injection is not recommended in patien...
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) ] Acute Gallbladder Disease [see Warnings and Precautions (5.3) ] Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions (5.4) ] Heart Rate Increase [see Warnings and Precautions (5.5) ] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.6) ] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.9) ] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.10) ] Most common adverse reactions, reported in greater than or equal to 5% are: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bio...
Indications and Usage………………………………………………05/2025 Dosage and Administration, Patient Selection (2.1)...…(Removed) 05/2025 Contraindications, Pregnancy (4)………………………(Removed) 05/2025 Warnings and Precautions, Severe Gastrointestinal Adverse Reactions (5.7)………………10/2025 Pulmonary Aspiration During General Anesthesia or Deep Sedation (5.10)………………………………………..11/2024
Source: FDA SPL label for Liraglutide (Biocon Pharma Inc.), effective 20251016. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 3,068 | 2,759 | 2,313 | 1,876 | 1,925 | 1,678 | 1,992 | 1,221 |
13,762 reports blaming this drug for every million Medicare prescriptions filled, which is 5.0× the typical drug on this site. (4,842 reports in 2024–2026, against 351,843 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 04/2026 | Class II | Lupin Pharmaceuticals Inc. | Presence of particulate matter: a white thread-like structure in the cartridge |
| 03/2021 | Class II | Novo Nordisk Inc | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. |
| 03/2021 | Class II | Novo Nordisk Inc | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $508,542 in payments to US physicians and hospitals tied to this drug across 3,042 transactions (Victoza $377,496, Saxenda $131,046).
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Victoza 3-Pak | 181,068 | $1,121 |
| Victoza 2-Pak | 108,521 | $717 |
| Liraglutide | 62,254 | $773 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.