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Gemcitabine

Published: July 26, 2026Updated: July 26, 2026

Gemcitabine is a nucleoside analog chemotherapy agent that interferes with DNA synthesis, causing cancer cells to die. It is primarily used to treat pancreatic cancer, as well as bladder, breast, ovarian, and non-small cell lung cancers.

Quick summary

Gemcitabine is a chemotherapy drug that disrupts DNA synthesis in cancer cells to slow or stop tumor growth.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
L01BC05
RxNorm
12574
Generic
Gemcitabine
Class
atc-l01
Brands
Infugem, Avgemsi, Inlexzo
Availability
rx
Lactation
unknown
Routes
—
Forms
injection, solution
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: Single dose approximately 10 times the standard therapeutic dose that may cause serious toxicity
Chronic overdose: Cumulative doses exceeding recommended limits can lead to severe bone marrow suppression and multi-organ toxicity
Immediate actions
Contact poison control immediately, supportive care including fluid resuscitation, close monitoring of hematologic and hepatic function, blood product transfusion as needed
Antidote
No specific antidote available(Treatment is supportive and symptomatic; no proven antidote exists)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks to the mother

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

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring

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

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use near term due to potential fetal toxicity

Monitor

regular fetal monitoring and uterine activity monitoring

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

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during gemcitabine treatment and for at least 1 week after last dose

Monitor

not applicable

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

⚠

pediatric_age

children 12 17 years
caution
FDA Category
C
Dose Adjustment

weight-based dosing

Key Recommendations

use only in pediatric oncology settings with appropriate monitoring; efficacy established for some pediatric cancers

Monitor

close hematological monitoring and assessment of organ function

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly 65 years and older
caution
FDA Category
C
Dose Adjustment

no specific adjustment required

Key Recommendations

use with caution; no formal dose reduction required but monitor closely for toxicity

Monitor

regular monitoring of renal and hepatic function, hematological parameters

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild to moderate
caution
FDA Category
C
Dose Adjustment

no standard dose adjustment

Key Recommendations

use with caution; monitor renal function regularly

Monitor

monitor serum creatinine and creatinine clearance before each cycle

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
C
Dose Adjustment

no specific dose adjustment

Key Recommendations

use with caution in hepatic impairment; monitor liver function tests

Monitor

regular monitoring of liver function tests and bilirubin

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:1996

Gemcitabine was first approved by the FDA in 1996

drug_classWHO
2023

Drug class

Value:Antimetabolite (Nucleoside analog)

Gemcitabine is classified as an antimetabolite and nucleoside analog chemotherapy agent

usageNCI
2023

Common uses

Value:Pancreatic cancer, breast cancer, ovarian cancer, non-small cell lung cancer, bladder cancer

FDA-approved indications for Gemcitabine

mechanismFDA
2023

Mechanism of action

Value:Nucleoside metabolism inhibitor - inhibits DNA synthesis

Primary pharmacodynamic mechanism of Gemcitabine

Treatment of pancreatic cancer (advanced or metastatic), bladder cancer, non-small cell lung cancer, breast cancer, and ovarian cancer. May be used alone or in combination with other chemotherapy agents depending on cancer type and stage.

Gemcitabine is a pyrimidine nucleoside analog that is metabolized intracellularly to active diphosphate (dFdCDP) and triphosphate (dFdCTP) forms. The diphosphate inhibits ribonucleotide reductase, while the triphosphate is incorporated into DNA, blocking DNA synthesis and causing cell death, particularly in rapidly dividing cancer cells.

Given by intravenous infusion, typically weekly. Common side effects include bone marrow suppression (low blood counts), fatigue, nausea, and flu-like symptoms. Requires regular blood count monitoring. Contraindicated in pregnancy due to potential harm to fetus. Should be used with caution in patients with impaired liver or kidney function.

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 July 26, 2026. · Read our editorial policy