How should I take Nateglinide?

2 DOSAGE AND ADMINISTRATION The recommended dose of nateglinide is 120 mg orally three times daily before meals. The recommended dose of nateglinide is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated. Instruct patients to take nateglinide 1 to 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of nateglinide to reduce the risk of hypoglycemia [see Warnings and Precautions (5.1)] . Recommended dose is 120 mg three times daily (2) In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered. (2) Administer 1 to 30 minutes before meals (2) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. (2, 5.1)

What are the common side effects?

6 ADVERSE REACTIONS The 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..

Who should not take Nateglinide?

4 CONTRAINDICATIONS Nateglinide tablets are contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients.; History of hypersensitivity to nateglinide or its inactive ingredients (4).

Can I take Nateglinide during pregnancy?

8.1 Pregnancy Risk Summary The available data from published literature and the applicant's pharmacovigilance with use of nateglinide in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see Clinical Considerations ). Nateglinide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal reproduction studies, there was no teratogenicity in rats and rabbits administered oral nateglinide during organogenesis at approximately 27 and 8 times the maximum recommended human dose (MRHD), respectively, based on body surface area (BSA). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c > 7 and has been reported to be as high as 20% to 25% in women with a HbA1c > 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pre

Can children take Nateglinide?

8.4 Pediatric Use The safety and effectiveness of nateglinide have not been established in pediatric patients.

Does Nateglinide interact with other medicines?

7 DRUG INTERACTIONS Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with nateglinide and instructions for managing or preventing them.; Table 2: Clinically Significant Drug Interactions with Nateglinide Drugs That May Increase the Blood-Glucose-Lowering Effect of Nateglinide and Susceptibility to Hypoglycemia Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g., methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol.; Intervention: Dose reductions and increased frequency of glucose monitoring may be required when nateglinide is coadministered with these drugs.; Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octr.

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Nateglinide

Illustration of the usual dosage form, not a product photo.

Chemical structure · PubChem CID 5311309

glinidePrescription only (Schedule H)

Nateglinide

नाटेग्लिनाइड

Nateglinide tablets are an oral glinide used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is not for type 1 diabetes or diabetic ketoacidosis. The main safety headline is low blood sugar, especially if a meal is skipped.

Generic name: Nateglinide
Used for: Improving blood sugar control in adults with type 2 diabetes, with diet and exercise.
Label used: Tablets label, oral, DailyMed set e920b343, effective 2025-04
Prescription status (India): Prescription only (Schedule H) in the lists we checked
On NLEM 2022: Not found in the list we checked
NPPA price ceiling: Not listed in the lists we checked

More facts

Jan Aushadhi: Not found in the list we checked
Banned combinations: None found in the list we checked

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Compiled from official drug labels and Indian government sources. Always follow your doctor's or pharmacist's advice.

Safety at a glance

AlcoholCaution in label textSee wording
PregnancyCaution in label textSee wording
BreastfeedingCaution in label textSee wording
DrivingCaution in label textSee wording
KidneyCaution in label textSee wording
LiverCaution in label textSee wording

Taken only from the label text cited on this page. "Not mentioned" does not mean safe. Ask your doctor or pharmacist.

What is nateglinide used for?

The label describes nateglinide as an add-on to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

It is not for type 1 diabetes or for treating diabetic ketoacidosis.

Type 2 diabetes in adults

Source1

How does nateglinide work?

The label says nateglinide lowers blood glucose by stimulating the pancreas to release insulin. This depends on working beta-cells.

The insulin release is glucose dependent and lessens when sugar is low.

Source1

How is nateglinide usually taken?

This page covers the US label for nateglinide tablets taken by mouth, with the dosing the label gives for adults.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults, the label describes taking nateglinide by mouth three times daily, 1 to 30 minutes before meals. A lower amount is described for people already near their sugar goal.

If a meal is skipped, the label describes skipping that scheduled dose to reduce the risk of low blood sugar.

Three times daily before meals
Take 1 to 30 minutes before eating
Skip the dose if a meal is skipped

Source1

What are the side effects of nateglinide?

Common

Common effects in the label are upper respiratory infection, back pain, flu symptoms, dizziness, joint problems and diarrhoea.
Low blood sugar
Upper respiratory infection
Back pain
Dizziness
Diarrhoea

Serious: get help

The serious effect described is hypoglycaemia, which can cause seizures and may be life-threatening when severe.

Source1

Who should be careful with nateglinide?

It must not be used in people with a history of allergy to nateglinide or its ingredients, or in type 1 diabetes or ketoacidosis.

Low blood sugar can impair concentration and reaction time. Kidney or liver impairment may raise the risk, and symptoms may be less noticeable with long-standing diabetes or beta-blockers.

The label says pregnancy data are insufficient and use is only if benefit justifies risk.

Allergy to nateglinide
Low blood sugar
Skipped meals
Kidney or liver impairment
Type 1 diabetes or ketoacidosis

Source1

What medicines interact with nateglinide?

Search interactions

NSAIDs, aspirin-type medicines
Beta blockers and MAO inhibitors
Steroids, thiazides, thyroid medicines
Rifampin, phenytoin, St John's Wort
The label lists medicines that may increase low-sugar risk, such as NSAIDs, salicylates, MAO inhibitors, non-selective beta blockers, some CYP2C9 inhibitors and alcohol.
Others may weaken its effect, such as thiazides, corticosteroids, thyroid products, rifampin, phenytoin and St John's Wort.

Source1

How should nateglinide be stored?

The label gives a storage range of 15 to 30 degrees C.

The label also says to keep the container tightly closed.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

Source1

Is nateglinide a prescription medicine in India?

In the Drugs Rules schedules we checked, nateglinide is listed under Schedule H (serial and rule: Schedule H, serial 348 (rules 65 and 97)). Schedule H medicines are sold only on a registered doctor's prescription.

We did not find nateglinide on the National List of Essential Medicines 2022 in the list we checked.

Source2

Frequently asked questions

Can I drink alcohol while taking nateglinide?

The label lists alcohol among things that may increase the sugar-lowering effect and low-sugar risk. Ask your doctor or pharmacist.

Source1

Is nateglinide safe in pregnancy and breastfeeding?

The label says data are insufficient and use only if benefit justifies risk. Ask your doctor or pharmacist about breastfeeding.

Source1

Should nateglinide be taken with food?

The label describes taking it shortly before meals and skipping the dose if a meal is skipped. Ask your doctor or pharmacist.

Source1

Can nateglinide affect driving or alertness?

The label says low blood sugar can impair concentration and reaction time, which matters for driving. Ask your doctor or pharmacist.

Source1

Can children or older adults take nateglinide?

The label describes use in adults only. Ask your doctor or pharmacist about children or older adults.

Source1

Is nateglinide on the NLEM and Jan Aushadhi list?

We did not find it on NLEM 2022. We did not find nateglinide in the Jan Aushadhi list we checked.

Source2

Sources

1U.S. FDA-approved label (DailyMed) (e920b343-f53e-7487-e053-2995a90a719a) Open source · 2026-10-15
2Drugs Rules 1945, Schedules (2022 consolidation) (Schedule H, Schedule H, serial 348 (rules 65 and 97)) Open source · 2026-10-15

Compiled by software from the sources above and checked by automated rules. Last checked: 2026-10-15 · How we use sources · Report a correction

This information is educational and is not a substitute for advice from your doctor or pharmacist. It does not tell you what dose you personally should take. In an emergency call 112.

Safety at a glance

What is nateglinide used for?

How does nateglinide work?

How is nateglinide usually taken?

What are the side effects of nateglinide?

Common

Serious: get help

Who should be careful with nateglinide?

What medicines interact with nateglinide?

How should nateglinide be stored?

Is nateglinide a prescription medicine in India?

Frequently asked questions

Sources

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