Short answer: Low blood sugar (hypoglycemia) is the most common Apidra side effect, as with all insulin. In pooled adult trials, nasopharyngitis affected 10.6% in type 1 diabetes and upper respiratory infection 10.5% in type 2. Severe low blood sugar affected 1.4% to 16.2% depending on the study, highest in children. Possible whole-body allergic reactions were reported in 4.3%. Apidra has no boxed warning.
What Apidra is approved for: Apidra is a rapid-acting mealtime insulin approved to improve blood sugar control in adults and children with diabetes (section 1).
Source
APIDRA (insulin glulisine) injection, for subcutaneous or intravenous use, prescribing information and Patient Information. Sanofi-Aventis U.S. LLC. DailyMed, version published November 27, 2025. DailyMed setid e7af6a7a-8046-4fb4-9979-4ec4230b23aa
No. The current Apidra label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Apidra.
| Adverse reaction | APIDRA, % (n=950) | All comparators, % (n=641) |
|---|---|---|
| Nasopharyngitis | 10.6 | 12.9 |
| Hypoglycemia (severe symptomatic only) | 6.8 | 6.7 |
| Upper respiratory tract infection | 6.6 | 5.6 |
| Influenza | 4.0 | 5.0 |
The comparators were insulin lispro, regular human insulin and insulin aspart, not placebo. The hypoglycemia row counts only severe symptomatic episodes. Influenza is listed though under 5% on Apidra.
| Adverse 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 |
The comparison is regular human insulin, not placebo. Hypertension is listed though under 5% on Apidra.
| Adverse reaction | APIDRA, % (n=277) | Insulin Lispro, % (n=295) |
|---|---|---|
| Nasopharyngitis | 9.0 | 9.5 |
| Upper respiratory tract infection | 8.3 | 10.8 |
| Headache | 6.9 | 11.2 |
| Hypoglycemic seizure | 6.1 | 4.7 |
| Study and group | Events per month per patient | Percent of patients (n/total N) |
|---|---|---|
| Type 1 adults, 12 weeks with insulin glargine: APIDRA pre-meal | 0.05 | 8.4% (24/286) |
| Type 1 adults, 12 weeks with insulin glargine: APIDRA post-meal | 0.05 | 8.4% (25/296) |
| Type 1 adults, 12 weeks with insulin glargine: regular human insulin | 0.13 | 10.1% (28/278) |
| Type 1 adults, 26 weeks with insulin glargine: APIDRA | 0.02 | 4.8% (16/339) |
| Type 1 adults, 26 weeks with insulin glargine: insulin lispro | 0.02 | 4.0% (13/333) |
| Type 2 adults, 26 weeks with NPH human insulin: APIDRA | 0.00 | 1.4% (6/416) |
| Type 2 adults, 26 weeks with NPH human insulin: regular human insulin | 0.00 | 1.2% (5/420) |
| Type 1 children, 26 weeks: APIDRA | 0.09 | 16.2% (45/277) |
| Type 1 children, 26 weeks: insulin lispro | 0.08 | 19.3% (57/295) |
Severe meant an episode needing another person's help, with blood glucose under 36 mg/dL or prompt recovery after carbohydrate, IV glucose or glucagon. Children had a higher rate than adults in both groups.
| Measure | APIDRA (n=29) | Insulin Aspart (n=30) |
|---|---|---|
| Catheter occlusions/month | 0.08 | 0.15 |
| Infusion site reactions | 10.3% (3/29) | 13.3% (4/30) |
A 12-week study of adults with type 1 diabetes using an insulin pump (n=59).
In trials up to 12 months, possible whole-body allergic reactions were reported in 79 of 1833 patients (4.3%) on Apidra and 58 of 1524 (3.8%) on comparator short-acting insulins. One patient on Apidra stopped permanently because of one.
Redness, swelling or itching at the injection site usually clears in a few days to a few weeks, but sometimes means stopping Apidra. The label notes some of these reactions may come from skin cleansers or injection technique.
Fast improvement in blood sugar control has been linked to a temporary change in eye focus, worsening diabetic eye disease and painful nerve symptoms. Skin pits or thickening, swelling from sodium retention and weight gain can also occur.
Cross-reactive insulin antibodies stayed near baseline for 6 months in type 1 patients on Apidra and then fell. The label found no link between antibody levels and A1C, insulin dose or low blood sugar.
Reported after approval: other insulins, particularly long-acting insulins, given by mistake instead of Apidra, and localized cutaneous amyloidosis (lumps under the skin) at injection sites.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Apidra is not used during an episode of low blood sugar, or by people allergic to insulin glulisine or any of its inactive ingredients.
Never share a pen, syringe or needle. SoloStar pens are never shared, even if the needle is changed, and vial users never reuse or share needles or syringes, because of the risk of passing on blood-borne infections.
Changes in insulin regimen. Changing insulin, strength, maker, type, injection site or method can cause high or low blood sugar, so changes are made under close medical supervision with more glucose checks. In type 2 diabetes, oral diabetes medicines may need adjusting.
Low blood sugar. Hypoglycemia is the most common reaction to all insulins. Severe episodes can cause seizures, unconsciousness or death and can affect driving. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows. Kidney or liver problems can raise the risk.
Medication mix-ups. Mix-ups between insulin products have been reported, so the insulin label is checked before each injection.
Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.
Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Apidra is stopped if it does.
Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.
Insulin pump failure. A pump or infusion set malfunction, or degraded insulin, can quickly lead to high blood sugar and ketoacidosis. Pump users are trained to give insulin by injection and keep backup insulin on hand.
From the Patient Information that comes with Apidra:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.