What the label lists and what reports show
Insulin aspart side effects
Insulin aspart's FDA label lists its adverse reactions in its own words. FAERS holds 63,003 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 (10,060 reports).
- No generic listed
Check it at the source: the insulin aspart FDA label on DailyMed (effective June 21, 2023, 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 FIASP?FIASP 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 heart beat • low potassium in your blood (hypokalemia). • serious allergic reactions (whole body reactions). Get emergency medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: o a rash over your whole body, trouble breathing, a fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness, confusion. • heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with FIASP may cause heart failure in some people. […]
Source: FDA drug label, Novo Nordisk, effective June 21, 2023 (SPL set 834e7efc-393f-4c55-9125-628562a8a5cf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse reactions are described elsewhere in labeling: • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions ( 5.2 )] • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Hypokalemia [see Warnings and Precautions ( 5.5 )] • Hypersensitivity and allergic reactions [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with FIASP include: hypoglycemia, allergic reactions, hypersensitivity, injection/infusion site reactions, lipodystrophy, and weight gain ( 6.1 ). 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. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Insulin Aspart label published by Novo Nordisk Pharma, Inc. of February 28, 2023; the label quoted above does not print one.
| Reaction | Insulin Aspart + NPH (%) (n= 91) | Human Regular Insulin + NPH (%) (n= 91) |
|---|---|---|
| Hyporeflexia | 11 | 7 |
| Onychomycosis | 10 | 5 |
| Sensory disturbance | 9 | 7 |
| Urinary tract infection | 8 | 7 |
| Chest pain | 5 | 3 |
| Headache | 5 | 3 |
| Skin disorder | 5 | 2 |
| Abdominal pain | 5 | 1 |
| Sinusitis | 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, effective June 21, 2023 (SPL set 834e7efc-393f-4c55-9125-628562a8a5cf), via openFDA; the full label on DailyMed
What do FAERS reports show?
63,003 reports list insulin aspart among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,460 are coded as a death and 20,796 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, 6 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 aspart: 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