What the label lists and what reports show
Nateglinide side effects
Nateglinide's FDA label: “Table 1 shows the most common adverse reactions associated with nateglinide.” FAERS holds 1,333 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 (76 reports).
- Generic listed
Check it at the source: the nateglinide FDA label on DailyMed (effective February 24, 2025, Strides Pharma Science Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsTable 1 shows the most common adverse reactions associated with nateglinide.
Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in Nateglinide-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials
| Reaction | Placebo N = 458 | Nateglinide N = 1441 |
|---|---|---|
| Upper Respiratory Infection | 8.1 | 10.5 |
| Back Pain | 3.7 | 4.0 |
| Flu Symptoms | 2.6 | 3.6 |
| Dizziness | 2.2 | 3.6 |
| Arthropathy | 2.2 | 3.3 |
| Diarrhea | 3.1 | 3.2 |
| Accidental Trauma | 1.7 | 2.9 |
| Bronchitis | 2.6 | 2.7 |
| Coughing | 2.2 | 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 serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1)] Common adverse reactions associated with nateglinide (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc at 1-877-244-9825 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 practice. In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with nateglinide. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with nateglinide.
Source: FDA drug label, Strides Pharma Science Limited, effective February 24, 2025 (SPL set 0ccf9b07-3c21-482d-abeb-a06ceb482c7b), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,333 reports list nateglinide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 149 are coded as a death and 548 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 22 reactions below, 4 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?
- Nateglinide: 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