What the label lists and what reports show
Insulin degludec and liraglutide side effects
Insulin degludec and liraglutide's FDA label: “Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection.” FAERS holds 1,628 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (189 reports).
- No generic listed
- Boxed warning
Check it at the source: the insulin degludec and liraglutide FDA label on DailyMed (effective October 14, 2025, Novo Nordisk); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XULTOPHY 100/3.6?XULTOPHY 100/3.6 may cause serious side effects that can lead to death, including: • See “What is the most important information I should know about XULTOPHY 100/3.6?” • inflammation of your pancreas (pancreatitis). Stop using XULTOPHY 100/3.6 and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use XULTOPHY 100/3.6 with another medicine that can cause low blood sugar. […]
Source: FDA drug label, Novo Nordisk, effective October 14, 2025 (SPL set 21335fe4-d395-4501-ac2a-2f20d7520da9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection.
Table 3: Adverse Reactions Occurring in ≥5% of XULTOPHY 100/3.6-Treated Patients with Type 2 Diabetes Mellitus
| Reaction | XULTOPHY 100/3.6 N = 1881 % |
|---|---|
| Nasopharyngitis | 10 |
| Headache | 9 |
| Nausea | 8 |
| Diarrhea | 8 |
| Increased Lipase | 7 |
| Upper respiratory tract infection | 6 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 ( 5.6 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.7 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.8 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.10 )] • Hypokalemia [see Warnings and Precautions ( 5.11 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.13 )] • Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection. ( 6 ) • Immunogenicity-related events, including urticaria, were more common among liraglutide-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. ( 12.6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Novo Nordisk, effective October 14, 2025 (SPL set 21335fe4-d395-4501-ac2a-2f20d7520da9), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,628 reports list insulin degludec and liraglutide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 630 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Insulin degludec and liraglutide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions