What the label lists and what reports show
Sotagliflozin side effects
Sotagliflozin's FDA label: “Most common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia.” FAERS holds 541 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 dizziness (52 reports).
- No generic listed
Check it at the source: the sotagliflozin FDA label on DailyMed (effective August 12, 2026, Lexicon Pharmaceuticals, Inc.); 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 INPEFA?INPEFA can cause serious side effects, including: See “ What is the most important information I should know about INPEFA? ” Low blood sugar (hypoglycemia). If you take INPEFA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INPEFA. Signs and symptoms of low blood sugar may include: headache shaking or feeling jittery irritability fast heartbeat weakness drowsiness sweating confusion dizziness hunger The most common side effects of INPEFA include: urinary tract infection dehydration diarrhea low blood sugar levels These are not all the possible side effects of INPEFA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Lexicon Pharmaceuticals, Inc., effective August 12, 2026 (SPL set 1a46614e-05f6-421a-b6f4-d6f8760d643a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
Table 1 Adverse Reactions Reported in ≥ 2% of Patients Treated with INPEFA and Greater Than Placebo in Either SOLOIST or SCORED
| Reaction | Placebo (%) N = 611 | INPEFA (%) N = 605 | Placebo (%) N = 5,286 | INPEFA (%) N = 5,291 |
|---|---|---|---|---|
| Urinary tract infection | 7.2 | 8.6 | 11.0 | 11.5 |
| Volume depletion | 8.8 | 9.3 | 4.0 | 5.2 |
| Diarrhea | 4.1 | 6.9 | 6.0 | 8.4 |
| Hypoglycemia | 2.8 | 4.3 | 7.9 | 7.7 |
| Dizziness | 2.5 | 2.6 | 2.8 | 3.3 |
| Genital mycotic infection | 0.2 | 0.8 | 0.9 | 2.4 |
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 important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions ( 5.1 )] Volume Depletion [see Warnings and Precautions ( 5.2 )] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections [see Warnings and Precautions ( 5.3 )] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lexicon at 1-855-330-2573 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the phase 3 (SOLOIST [see Clinical Studies ( 14.1 )] and SCORED [see Clinical Studies ( 14.2 )] ) placebo-controlled trials, 5,896 subjects received INPEFA. In the SOLOIST study, 336 patients (56%) reached the 400 mg dose. …
Source: FDA drug label, Lexicon Pharmaceuticals, Inc., effective August 12, 2026 (SPL set 1a46614e-05f6-421a-b6f4-d6f8760d643a), via openFDA; the full label on DailyMed
What do FAERS reports show?
541 reports list sotagliflozin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 103 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 19 reactions below, 8 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?
- Sotagliflozin: 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