Short answer: The Soliqua label names low blood sugar as the most common side effect of insulin-containing products. In two 30-week trials of 834 people with type 2 diabetes, the other most common reactions were nausea (10.0%), nasopharyngitis (7.0%), diarrhea (7.0%), upper respiratory tract infection (5.5%) and headache (5.4%). These trials had no placebo column. Soliqua has no boxed warning.
What Soliqua is approved for: Soliqua 100/33 is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes (section 1). The label says it is not recommended with any other product containing a GLP-1 receptor agonist, is not for diabetic ketoacidosis, and has not been studied with mealtime (prandial) insulin.
Source
SOLIQUA 100/33 (insulin glargine and lixisenatide) injection, for subcutaneous use, prescribing information and Medication Guide. Sanofi. DailyMed, version published March 20, 2026. DailyMed setid 4bba538b-cf7c-4310-ae8f-cb711ed21bcc
No. The current Soliqua 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 Soliqua.
| Adverse reaction | SOLIQUA 100/33, % (n=834) |
|---|---|
| Nausea | 10.0 |
| Nasopharyngitis | 7.0 |
| Diarrhea | 7.0 |
| Upper respiratory tract infection | 5.5 |
| Headache | 5.4 |
Two 30-week studies (Study A and Study B) of 834 adults with type 2 diabetes on Soliqua, mean treatment 203 days; mean age about 59, mean diabetes duration 10.3 years. The table has no placebo column.
| Episode type | SOLIQUA 100/33 Study A (N=469) | SOLIQUA 100/33 Study B (N=365) |
|---|---|---|
| Severe symptomatic hypoglycemia (%) | 0 | 1.1 |
| Hypoglycemia (self-monitored plasma glucose <54 mg/dL) (%) | 8.1 | 17.8 |
Severe symptomatic hypoglycemia means an event needing another person to give carbohydrate, glucagon or other help. The label says no clinically important difference in severe low blood sugar was seen between Soliqua and comparators.
In Study A, nausea was reported in 9.6% on Soliqua vs 24% on lixisenatide alone and 3.6% on insulin glargine alone. Vomiting was 3.2% on Soliqua vs 6.4% on lixisenatide and 1.5% on insulin glargine. Stomach and gut reactions were more frequent at the beginning of Soliqua treatment.
Injection-site reactions (such as bruising, pain, redness, swelling or itching) were reported in 1.7% of people on Soliqua.
Pancreatitis in lixisenatide trials: 21 cases on lixisenatide vs 14 on comparators (21 vs 17 per 10,000 patient-years). Gallstones were 0.4% vs 0.2% on placebo and gallbladder inflammation 0.3% vs 0.2% in a heart outcomes trial of lixisenatide.
Anaphylaxis in the lixisenatide program: 0.2% (16 per 10,000 patient-years) vs 0.1% (7 per 10,000) on placebo. Allergic reactions possibly related to the medicine: 0.4% vs 0.2%.
The label also lists lipodystrophy (skin dents or thickening at injection sites), swelling from salt and water retention, and weight gain, which it attributes to insulin's effects.
In a pooled analysis of lixisenatide studies, 70% of people had antibodies at week 24. In the 2.4% with the highest levels, the blood sugar response was weaker.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Anaphylaxis and serious allergic reactions. Severe, life-threatening allergic reactions, including anaphylaxis and angioedema, can happen with lixisenatide and with insulins. If one happens, Soliqua is stopped and medical help is sought promptly.
Acute pancreatitis. Pancreatitis, including fatal forms, has been seen with GLP-1 receptor agonists. Signs include lasting or severe stomach pain, sometimes spreading to the back. If it is suspected, Soliqua is stopped.
Never share a pen. A Soliqua pen must never be shared, even with a new needle, because of the risk of passing on blood-borne infections.
Changes in insulin regimen. Changing insulin strength, maker, type, injection site or method can push blood sugar too high or too low. Injecting repeatedly into areas of lipodystrophy or skin amyloid can raise blood sugar, and suddenly switching to an unaffected area can lower it. Changes are made under close medical supervision with more frequent blood sugar checks.
Overdose from medication errors. Soliqua contains two drugs. More than 60 units a day can mean an overdose of lixisenatide. Mix-ups with other insulins have happened, so the label is checked before each injection, and Soliqua is not used with other GLP-1 receptor agonists.
Low blood sugar. Hypoglycemia is the most common reaction with insulin-containing products and can be life-threatening. It can affect concentration and reaction time, such as when driving. Soliqua is not used during a low blood sugar episode. The long action of insulin glargine may slow recovery from a low.
Kidney injury from fluid loss. Acute kidney injury, sometimes needing dialysis, has been reported with GLP-1 receptor agonists, mostly after dehydration from nausea, vomiting or diarrhea. Soliqua is not recommended in end-stage kidney disease.
Severe stomach and gut reactions. Stomach and gut reactions, sometimes severe, have been reported. Soliqua is not recommended for people with severe gastroparesis.
Antibodies. People may develop antibodies to insulin and lixisenatide. If blood sugar control worsens, or there are significant injection-site or allergic reactions, another diabetes treatment may be considered.
Low potassium. Insulin moves potassium into cells and can cause hypokalemia, which untreated can be life-threatening. Potassium is checked in people at risk.
Fluid retention and heart failure with TZDs. Thiazolidinediones (such as pioglitazone) can cause fluid retention with insulin products, which may lead to or worsen heart failure. People on both are watched for heart failure signs.
Gallbladder disease. Gallstones and gallbladder inflammation have been reported with GLP-1 receptor agonists. If gallstones are suspected, the label calls for gallbladder tests.
Breathing in stomach contents during anesthesia. Soliqua slows stomach emptying. Rare cases of pulmonary aspiration under general anesthesia or deep sedation have been reported with GLP-1 receptor agonists. The label says to tell the care team about Soliqua before any planned procedure.
From the Medication Guide that comes with Soliqua:
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.