What the label lists and what reports show
Insulin glargine and lixisenatide side effects
Insulin glargine and lixisenatide's FDA label: “The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.” FAERS holds 3,552 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 (460 reports).
- No generic listed
Check it at the source: the insulin glargine and lixisenatide FDA label on DailyMed (effective March 18, 2026, Sanofi-Aventis U.S. LLC); 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 SOLIQUA 100/33?SOLIQUA 100/33 can cause serious side effects including: See " What is the most important information I should know about SOLIQUA 100/33? " severe allergic reactions. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction including swelling of your face, lips, tongue or throat problems breathing or swallowing severe rash or itching fainting or feeling dizzy very rapid heartbeat low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include: Dizziness or light-headedness sweating confusion or drowsiness headache blurred vision slurred speech shakiness fast heartbeat anxiety, irritability, or mood changes hunger weakness feeling jittery dehydration leading to kidney problems. […]
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective March 18, 2026 (SPL set 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.
Table 3: Adverse Reactions Occurring in ≥5% of SOLIQUA 100/33–Treated Patients with Type 2 Diabetes Mellitus from Two Pooled Clinical Trials
| Reaction | SOLIQUA 100/33, % (n=834) |
|---|---|
| Nausea | 10.0 |
| Nasopharyngitis | 7.0 |
| Diarrhea | 7.0 |
| Upper respiratory tract infection | 5.5 |
| Headache | 5.4 |
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.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere: Anaphylaxis and Serious Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Acute Pancreatitis [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.6) ] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.7) ] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.8) ] Hypokalemia [see Warnings and Precautions (5.10) ] Acute Gallbladder Disease [see Warnings and Precautions (5.12) ] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.13) ] The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache. ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective March 18, 2026 (SPL set 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,552 reports list insulin glargine and lixisenatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 41 are coded as a death and 244 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 20 reactions below, 7 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 glargine and lixisenatide: 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