Key points
- Gemcitabine (Gemzar) is an injectable chemotherapy drug that stops cancer cells from making DNA [1].
- It is used for pancreatic, lung, ovarian, breast and bile duct cancer, usually with other drugs [1, 5].
- In pancreatic cancer that has spread, adding another drug (nab-paclitaxel) helped patients live longer [3].
- In bile duct cancer, together with cisplatin it is the basis of treatment, and adding immunotherapy has helped patients live longer still [5, 6].
- The most common side effects: nausea, low blood counts, fever and flu-like symptoms, and skin rash [1].
- Serious but uncommon side effects: lung, kidney or liver damage, and severe skin reactions [1].
What is this drug and how does it work?
For physicians
Gemcitabine is structurally similar to deoxycytidine (one of the building blocks of DNA) and kills cells that are making DNA [1]. Inside the cell it is converted to two active forms (diphosphate and triphosphate): the diphosphate inhibits ribonucleotide reductase and depletes the nucleotides needed for DNA synthesis, and the triphosphate is incorporated into DNA in place of dCTP. After gemcitabine is incorporated, only one more nucleotide is added to the strand, after which DNA synthesis stops and apoptosis begins [1].
Gemcitabine is usually given in combination with other drugs (such as cisplatin, carboplatin, paclitaxel or nab-paclitaxel) and sometimes as a single agent [1, 3].
Which cancers is it used for?
Your doctor may prescribe this drug for:
- Locally advanced or spread pancreatic cancer [1]
- Pancreatic cancer that has spread [3]
- Pancreatic cancer after surgery [4]
- Advanced non-small cell lung cancer [1]
- Advanced ovarian cancer [1]
- Breast cancer that has spread [1]
- Advanced bile duct cancer [5, 6]
- Advanced urothelial (bladder) cancer [7]
- Locoregionally advanced nasopharyngeal cancer [8]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Setting |
|---|---|
| Locally advanced or metastatic pancreatic cancer | First-line monotherapy, or after fluorouracil (FDA label) [1] |
| Metastatic pancreatic cancer | First line with nab-paclitaxel (outside the gemcitabine label) [3] |
| Pancreatic cancer after surgery | Adjuvant treatment with capecitabine (outside the FDA label) [4] |
| Advanced non-small cell lung cancer | First line with cisplatin (FDA label) [1] |
| Advanced ovarian cancer | Relapse at least 6 months after platinum-based therapy, with carboplatin (FDA label) [1] |
| Metastatic breast cancer | First line with paclitaxel after failure of anthracycline-containing adjuvant chemotherapy (FDA label) [1] |
| Advanced biliary tract cancer | First line with cisplatin, with or without durvalumab (outside the gemcitabine label) [5, 6] |
| Advanced urothelial (bladder) cancer | First line with cisplatin, with or without nivolumab (outside the gemcitabine label) [7] |
| Locoregionally advanced nasopharyngeal cancer | Induction chemotherapy with cisplatin before chemoradiotherapy (outside the FDA label) [8] |
The off-label uses of gemcitabine are accepted in clinical guidelines on the basis of phase 3 trials but are not listed in the official gemcitabine label.
| Cancer | Key evidence |
|---|---|
| Locally advanced or metastatic pancreatic cancer | Compared with fluorouracil: clinical benefit response 23.8% vs 4.8% and median survival 5.65 vs 4.41 months [1, 2]. |
| Metastatic pancreatic cancer | MPACT: median overall survival 8.5 vs 6.7 months with gemcitabine alone (hazard ratio 0.72) [3]. |
| Pancreatic cancer after surgery | ESPAC-4: median overall survival 28.0 vs 25.5 months with gemcitabine alone (hazard ratio 0.82) [4]. |
| Advanced non-small cell lung cancer | Median overall survival 9.0 vs 7.6 months with cisplatin alone [1]. |
| Advanced ovarian cancer | Median progression-free survival 8.6 vs 5.8 months (hazard ratio 0.72); no significant difference in overall survival [1]. |
| Metastatic breast cancer | Median time to progression 5.2 vs 2.9 months (hazard ratio 0.650); the overall survival difference was not significant [1]. |
| Advanced biliary tract cancer | ABC-02: median overall survival 11.7 vs 8.1 months with gemcitabine alone (hazard ratio 0.64) [5]. TOPAZ-1: adding durvalumab, hazard ratio for death 0.80 [6]. |
| Advanced urothelial (bladder) cancer | CheckMate 901: median overall survival 21.7 months with nivolumab plus gemcitabine-cisplatin vs 18.9 months (hazard ratio 0.78) [7]. |
| Locoregionally advanced nasopharyngeal cancer | 3-year recurrence-free survival 85.3% vs 76.5% (hazard ratio 0.51) [8]. |
In pancreatic cancer, more intensive combination regimens have been superior to gemcitabine alone in patients with good performance status: FOLFIRINOX in metastatic disease (median overall survival 11.1 vs 6.8 months) [9] and modified FOLFIRINOX as adjuvant treatment (median overall survival 54.4 vs 35.0 months) [10]. Gemcitabine alone remains an option for patients who cannot tolerate combination regimens.
How it is taken and dosing
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Treatment regimens and doses: index4 regimens
Gemcitabine is given only as an intravenous infusion (drip) at a treatment centre, usually over 30 minutes [1]. The schedule varies with the type of cancer; for example, once a week with rest weeks, or on days 1 and 8 of each 21-day cycle [1].
A full blood count is done before each infusion, and if white blood cells or platelets are very low, the dose is lowered or the infusion is postponed [1]. Kidney and liver function are also checked before starting and regularly during treatment [1].
Your doctor decides the number of cycles and how long treatment lasts based on the type of cancer, the response and side effects. Do not skip any treatment session without arranging it with your treatment team, and do not stop treatment on your own.
- Before starting and before each dose: CBC with differential and platelets before each dose; renal and hepatic function before starting and periodically. With liver metastases or a history of hepatitis, alcoholism or cirrhosis, there is a risk of worsening hepatic insufficiency [1].
- Infusion: dilute in 0.9% sodium chloride (final concentration at least 0.1 mg/mL), infused over 30 minutes. Prolonging the infusion beyond 60 minutes or giving it more than once a week increases hypotension, severe flu-like symptoms, myelosuppression and asthenia [1].
- Monitoring: signs of HUS (microangiopathic haemolytic anaemia, raised bilirubin or LDH, severe thrombocytopenia, rising creatinine); pulmonary symptoms up to 2 weeks after the last dose [1].
- Discontinue permanently: severe skin reactions (SJS/TEN/DRESS/AGEP), unexplained dyspnoea or severe pulmonary toxicity, HUS or severe renal impairment, severe hepatotoxicity, capillary leak syndrome and PRES. Other grade 3 to 4 non-haematological toxicities: withhold or reduce the dose by 50% until resolved; no dose modification is needed for alopecia, nausea and vomiting [1].
- Kidney and liver: no clinical study has been done in renal or hepatic impairment, and the label gives no specific dose [1].
For physicians
Standard dosing (FDA label)
Pancreatic cancer (monotherapy)
Locally advanced or metastatic; first line or after fluorouracil
Locally advanced or metastatic; first line or after fluorouracil [1]
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 8 | |||
| Gemcitabine | 1000 mg/m² | IV, 30-minute infusion | Weekly for 7 weeks, then 1 week of rest |
| From week 9 | |||
| Gemcitabine | 1000 mg/m² | IV, 30-minute infusion | Days 1, 8 and 15 |
Dose modification on the day of treatment: neutrophils 1000 or more and platelets 100,000 or more per µL: full dose; neutrophils 500 to 999 or platelets 50,000 to 99,999: 75% of the dose; neutrophils below 500 or platelets below 50,000: withhold [1].
Non-small cell lung cancer (with cisplatin)
First line, inoperable locally advanced or metastatic
First line, inoperable locally advanced or metastatic [1]
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| 28-day schedule | |||
| Gemcitabine | 1000 mg/m² | IV, 30-minute infusion | Days 1, 8 and 15 |
| Or 21-day schedule | |||
| Gemcitabine | 1250 mg/m² | IV, 30-minute infusion | Days 1 and 8 |
| Both schedules | |||
| Cisplatin | 100 mg/m² | IV | Day 1, after gemcitabine |
Haematological dose modification as for pancreatic cancer (75% of the dose or withhold based on neutrophils and platelets on the day of treatment) [1].
Ovarian cancer (with carboplatin)
Advanced, relapse at least 6 months after platinum-based therapyCycle length: Every 21 days
Advanced, relapse at least 6 months after platinum-based therapy [1]
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Each cycle | |||
| Gemcitabine | 1000 mg/m² | IV, 30-minute infusion | Days 1 and 8 |
| Carboplatin | AUC 4 | IV | Day 1, after gemcitabine |
Day 1: neutrophils below 1500 or platelets below 100,000 per µL: delay the cycle. Day 8: neutrophils 1000 to 1499 or platelets 75,000 to 99,999: 50% of the dose; neutrophils below 1000 or platelets below 75,000: withhold. After neutrophils below 500 for more than 5 days, below 100 for more than 3 days, febrile neutropenia, platelets below 25,000 or a cycle delay of more than one week: permanently reduce to 800 mg/m² on days 1 and 8; on recurrence: 800 mg/m² on day 1 only [1].
Metastatic breast cancer (with paclitaxel)
First line after failure of anthracycline-containing adjuvant chemotherapyCycle length: Every 21 days
First line after failure of anthracycline-containing adjuvant chemotherapy [1]
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Each cycle | |||
| Paclitaxel | 175 mg/m² | IV, 3-hour infusion | Day 1, before gemcitabine |
| Gemcitabine | 1250 mg/m² | IV, 30-minute infusion | Days 1 and 8 |
Day 1: neutrophils below 1500 or platelets below 100,000 per µL: withhold. Day 8: neutrophils 1200 or more and platelets above 75,000: full dose; neutrophils 1000 to 1199 or platelets 50,000 to 75,000: 75% of the dose; neutrophils 700 to 999 and platelets 50,000 or more: 50% of the dose; neutrophils below 700 or platelets below 50,000: withhold [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
Common side effects
The most common side effects:
For physicians
| Adverse reaction | All grades | Grade 3 | Grade 4 |
|---|---|---|---|
| Nausea and vomiting | 69% | 13% | 1% |
| Fever | 41% | 2% | 0 |
| Rash | 30% | Less than 1% | 0 |
| Dyspnoea | 23% | 3% | Less than 1% |
| Diarrhoea | 19% | 1% | 0 |
| Alopecia | 15% | Less than 1% | 0 |
Other adverse reactions in the same group: flu-like symptoms (fever, asthenia, anorexia, headache, cough, chills, myalgia) 19%, peripheral oedema 20% and red cell transfusion 19% [1]. In combination regimens, haematological toxicity is more common [1].
| Abnormality | All grades | Grade 3 | Grade 4 |
|---|---|---|---|
| Anaemia | 68% | 7% | 1% |
| Raised ALT | 68% | 8% | 2% |
| Raised AST | 67% | 6% | 2% |
| Neutropenia | 63% | 19% | 6% |
| Raised alkaline phosphatase | 55% | 7% | 2% |
| Proteinuria | 45% | Less than 1% | 0 |
| Haematuria | 35% | Less than 1% | 0 |
| Thrombocytopenia | 24% | 4% | 1% |
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- Infection or bleeding because of low blood counts: a temperature of 38 °C, chills, bruising [1].
- Lung damage: new shortness of breath or cough, even up to 2 weeks after the last dose [1].
- Kidney and blood damage: passing less urine, dark urine, swelling or severe tiredness [1].
- Liver damage: yellow skin or eyes [1].
- A severe headache with seizures or blurred vision, severe skin reactions and harm to an unborn baby. If you are having radiotherapy at the same time, radiation side effects are worse [1].
For physicians
Gemcitabine has no boxed warning, but the FDA label lists these important warnings [1]:
- Myelosuppression: in 979 patients on gemcitabine alone, grade 3 to 4 neutropenia, anaemia and thrombocytopenia occurred in 25%, 8% and 5% respectively, and these figures are higher with combination regimens. Women, especially older women, are more likely to have severe neutropenia and thrombocytopenia [1].
- Pulmonary toxicity and respiratory failure: interstitial pneumonitis, pulmonary fibrosis, pulmonary oedema and acute respiratory distress syndrome have been reported, sometimes fatal despite stopping the drug; symptoms may start up to 2 weeks after the last dose [1].
- Haemolytic uraemic syndrome (HUS): occurred in 0.25% of 2429 patients and may lead to irreversible renal failure or the need for dialysis [1].
- Hepatotoxicity: drug-induced liver injury, including liver failure and death, has been reported; the risk is higher with liver metastases or a history of hepatitis, alcohol use or cirrhosis [1].
- Severe cutaneous adverse reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), DRESS and AGEP, which can be life-threatening [1].
- Exacerbation of radiation toxicity: giving it at the same time as radiotherapy (or 7 days apart or less) can cause severe and life-threatening oesophagitis and pneumonitis; radiation recall has also been reported [1].
- Capillary leak syndrome and posterior reversible encephalopathy syndrome (PRES) with headache, seizures, lethargy, hypertension, confusion and visual disturbance [1].
- Embryo-fetal toxicity and severe hypersensitivity (anaphylaxis) in people sensitive to gemcitabine [1].
When should I call my doctor?
Contact your treatment team straight away if you have [1]:
- Fever, chills or any sign of infection
- Bleeding, unusual bruising or signs of severe anaemia (paleness, shortness of breath or palpitations with little activity)
- Shortness of breath, wheezing or a new cough, even up to a few weeks after the last dose
- A change in the colour or amount of your urine
- Yellow skin or eyes, or pain and tenderness in the upper right abdomen
- A severe rash, peeling or blistering skin, or mouth sores
- A severe headache, seizures, confusion, or blurred or reduced vision
Interactions, pregnancy and precautions
- Radiotherapy: gemcitabine is not recommended at the same time as radiotherapy; when the gap from radiotherapy was more than 7 days, severe toxicity was not seen. If you are having or have recently had radiotherapy, be sure to tell your doctor [1].
- Pregnancy and contraception: a pregnancy test is done before starting. Women who could become pregnant should use effective contraception for 6 months, and men with a partner who could become pregnant for 3 months, after the last dose [1].
- Breastfeeding: do not breastfeed during treatment and for at least one week after the last dose [1].
- Fertility: based on animal studies, gemcitabine may reduce male fertility, and whether this is reversible is not known [1].
- Liver and kidney disease: tell your doctor if you have had hepatitis, cirrhosis, alcohol use or kidney disease; liver and kidney tests are done before starting and during treatment [1].
- Older adults: severe falls in platelets have been more common in people aged 65 and over, although no age-based dose adjustment is recommended [1].
- Other medicines: give your doctor and pharmacist a list of all your medicines, supplements and herbal products, especially when gemcitabine is given with other chemotherapy drugs.
Frequently asked questions
Will gemcitabine make my hair fall out?
Hair loss with gemcitabine alone is fairly uncommon; about one in 7 patients has it [1]. It is much more common with combination regimens; for example, in the study of gemcitabine with paclitaxel in breast cancer, almost all patients lost hair [1].
I have a fever and aches after the infusion; is that normal?
Why do I have a blood test before every infusion?
Gemcitabine can lower white blood cells, red blood cells and platelets. Your doctor uses the blood count on the day to decide whether a full dose, a lower dose or a delay is right [1].
Why do some patients get gemcitabine alone and others a combination?
Can I have radiotherapy at the same time?
The drug label does not recommend using it at the same time as radiotherapy, because it may cause severe inflammation of the oesophagus and lungs. Your treatment team decides the spacing and planning [1].
Scientific evidence
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Key studies
8 itemsIncreased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine
FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial
Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma
NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial
Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma
FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
Clinical guidelines
3 itemsPancreatic cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Pancreatic Adenocarcinoma, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology
Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Related cancer types
Treatment regimens (physicians)
References
10 referencesShow all references, 9 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial
- 3
- 4
- 5
- 6
- 7
- 8
- 9FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
- 10FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/gemcitabine/