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Gliclazide

Published: July 26, 2026Updated: August 20, 2026

Gliclazide is an oral antidiabetic medication classified as a sulfonylurea, used to manage type 2 diabetes by stimulating insulin release from the pancreas.

Quick summary

Gliclazide is an oral diabetes medicine that helps control blood sugar by stimulating insulin release from the pancreas.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 20, 2026Editorial policy

Key facts at a glance

ATC
A10BB09
RxNorm
4816
Generic
Gliclazide
Class
atc-a10
Brands
—
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses exceeding 1000mg may cause serious hypoglycemia and toxicity
Chronic overdose: Repeated supratherapeutic doses leading to cumulative hypoglycemic episodes
Immediate actions
Administer intravenous dextrose, activate charcoal if presentation within 1-2 hours
Antidote
Dextrose (Glucose)(Critical and life-saving in acute overdose)
Poison Control: 1-800-222-1222

Special Populations

10 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue use before pregnancy planning or avoid use during first trimester unless benefits clearly outweigh risks

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

switch to insulin

Key Recommendations

discontinue gliclazide and switch to insulin therapy for better glycemic control

Monitor

regular fetal growth monitoring and maternal glucose control

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

discontinue before delivery

Key Recommendations

switch to insulin and discontinue at least 2 weeks before expected delivery

Monitor

fetal monitoring and assessment for macrosomia

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

not applicable
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

do not use during breastfeeding as gliclazide is excreted in breast milk

Monitor

monitor infant for signs of hypoglycemia

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

not applicable
caution
FDA Category
N
Dose Adjustment

start with lowest effective dose

Key Recommendations

initiate therapy at half the adult starting dose and titrate slowly; monitor for hypoglycemia

Monitor

frequent blood glucose monitoring especially during dose titration

Use with caution and monitor for adverse effects.

✗

pediatric_age

children adolescents
contraindicated
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not indicated for use in children and adolescents due to lack of safety and efficacy data

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild
caution
FDA Category
N
Dose Adjustment

no adjustment needed for mild impairment

Key Recommendations

use with caution and monitor renal function periodically

Monitor

monitor renal function and blood glucose regularly

Use with caution and monitor for adverse effects.

⚠

renal_impairment

moderate severe
caution
FDA Category
N
Dose Adjustment

dose reduction recommended

Key Recommendations

reduce dose by 25-50% and use with close monitoring

Monitor

frequent blood glucose monitoring and renal function assessment

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild moderate
caution
FDA Category
N
Dose Adjustment

dose reduction may be needed

Key Recommendations

use with caution and consider dose reduction in moderate hepatic impairment

Monitor

monitor liver function tests and blood glucose closely

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe
unsafe
FDA Category
N
Dose Adjustment

avoid use

Key Recommendations

do not use in severe hepatic impairment due to impaired gluconeogenesis risk

Monitor

frequent monitoring if used in error

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:Sulfonylurea

Gliclazide belongs to the sulfonylurea class of antidiabetic medications

usageMedical guidelines
2023

Common uses

Value:Type 2 diabetes mellitus treatment

Primary therapeutic indication for glycemic control in type 2 diabetes

prescribingFDA
2023

FDA approval year

Value:1990

Year of FDA approval for gliclazide

mechanismMedical literature
2023

Mechanism of action

Value:Insulin secretagogue - stimulates pancreatic beta cells

Primary pharmacological mechanism of action

Treatment of type 2 diabetes mellitus in adults when diet control, exercise, and weight reduction alone are not sufficient to achieve glycemic control.

Gliclazide is a sulfonylurea that binds to and blocks ATP-sensitive potassium channels on pancreatic beta cells, causing cell depolarization and calcium influx, which stimulates insulin secretion.

Should be taken with meals to minimize gastrointestinal side effects. Risk of hypoglycemia, particularly in elderly patients, those with renal impairment, or when combined with other hypoglycemic agents. Not suitable for type 1 diabetes or diabetic ketoacidosis. Alcohol may enhance the hypoglycemic effect.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 20, 2026. · Read our editorial policy