What the label lists and what reports show
Insulin degludec side effects
Insulin degludec's FDA label lists its adverse reactions in its own words. FAERS holds 23,334 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 (3,746 reports).
- No generic listed
Check it at the source: the insulin degludec FDA label on DailyMed (effective July 1, 2022, Novo Nordisk Pharma, Inc.); 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 Insulin Degludec?Insulin Degludec may cause serious side effects that can lead to death, including: • Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: o dizziness or light-headedness o blurred vision o anxiety, irritability, or mood changes o sweating o slurred speech o hunger o confusion o shakiness o headache o fast heartbeat • Low potassium in your blood (hypokalemia). • Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Insulin Degludec may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Insulin Degludec. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Degludec. […]
Source: FDA drug label, Novo Nordisk Pharma, Inc., effective July 1, 2022 (SPL set c1be283d-4b1d-4996-b2a7-4488dbff3037), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions are also discussed elsewhere: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with Insulin Degludec are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Pharma, Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Insulin Degludec (N=1,102) |
|---|---|
| Nasopharyngitis | 23.9 % |
| Upper respiratory tract infection | 11.9 % |
| Headache | 11.8 % |
| Sinusitis | 5.1 % |
| Gastroenteritis | 5.1 % |
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.
Source: FDA drug label, Novo Nordisk Pharma, Inc., effective July 1, 2022 (SPL set c1be283d-4b1d-4996-b2a7-4488dbff3037), via openFDA; the full label on DailyMed
What do FAERS reports show?
23,334 reports list insulin degludec among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,281 are coded as a death and 6,810 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 21 reactions below, 5 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: 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