What the label lists and what reports show
Insulin glulisine side effects
Insulin glulisine's FDA label lists its adverse reactions in its own words. FAERS holds 10,109 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 (1,554 reports).
- No generic listed
Check it at the source: the insulin glulisine FDA label on DailyMed (effective November 25, 2025); 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 APIDRA?APIDRA 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: dizziness or light-headedness, sweating, trouble concentrating or confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, shortness of breath, trouble breathing, fast pulse, sweating, or feeling faint low potassium in your blood (hypokalemia). heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with APIDRA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. […]
Source: FDA drug label, sanofi-aventis U.S. LLC, effective November 25, 2025 (SPL set e7af6a7a-8046-4fb4-9979-4ec4230b23aa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypokalemia [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Adverse reactions commonly associated with APIDRA include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Table 2: Adverse Reactions Occurring ≥5% in Pooled Studies of Adults with Type 2 Diabetes
| Reaction | APIDRA, % (n=883) | Regular Human Insulin, % (n=883) |
|---|---|---|
| Upper respiratory tract infection | 10.5 | 7.7 |
| Nasopharyngitis | 7.6 | 8.2 |
| Edema peripheral | 7.5 | 7.8 |
| Influenza | 6.2 | 4.2 |
| Arthralgia | 5.9 | 6.3 |
| Hypertension | 3.9 | 5.3 |
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, sanofi-aventis U.S. LLC, effective November 25, 2025 (SPL set e7af6a7a-8046-4fb4-9979-4ec4230b23aa), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,109 reports list insulin glulisine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 806 are coded as a death and 4,075 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 23 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 glulisine: 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