Gemcitabine
Pronunciation: pronunciation varies by local usage.
- Generic name
- gemcitabine
- Drug class
- Nucleoside-analog (antimetabolite) chemotherapy
- Form
- Lyophilized powder for injection
- Route
- Intravenous infusion
- Legal status
- Prescription-only medicine (oncology use only)
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What gemcitabine is and how it works
Gemcitabine is a nucleoside-analog antimetabolite chemotherapy medicine given by intravenous infusion. It is used to treat specific cancers—advanced ovarian cancer, metastatic breast cancer, advanced non-small cell lung cancer, and advanced pancreatic cancer—under the supervision of an oncologist. (1)
Gemcitabine is administered only by intravenous infusion in a healthcare setting. The exact dose, schedule, and combination chemotherapy depend on the cancer type, body surface area, and blood-test results. It is not self-administered, and any dose or schedule change must be directed by the oncology team.
Mechanism of action: how gemcitabine works
Gemcitabine is a nucleoside-analog antimetabolite chemotherapy medicine. Mechanism-of-action detail beyond this classification was not established from the sources reviewed for this draft. (1)
What gemcitabine is used for
Advanced ovarian cancer
In combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1)
Metastatic breast cancer
In combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (unless anthracyclines are clinically contraindicated). (1)
Non-small cell lung cancer (NSCLC)
In combination with cisplatin, for the treatment of locally advanced or metastatic non-small cell lung cancer. (1)
Pancreatic cancer
As monotherapy for locally advanced or metastatic pancreatic cancer, including patients previously treated with 5‑fluorouracil. (1)
Before taking gemcitabine
Do not take / not appropriate for
- Do not receive gemcitabine if you have a known hypersensitivity to gemcitabine. (all indications) (1)
- Do not attempt to self-administer gemcitabine; it is given only by intravenous infusion by a healthcare professional in a clinical setting. (all products) (1)
Tell your clinician about
- Any known hypersensitivity to gemcitabine or any other medicines.
- Pregnancy, plans for pregnancy, or breastfeeding.
- Kidney or liver problems.
- All medications, vitamins, and herbal supplements you take.
- Any history of allergic reactions to chemotherapy or infused medicines.
How to take gemcitabine
- Gemcitabine is administered by intravenous infusion in a healthcare setting by oncology staff.
- The dose, infusion duration (usually 30 minutes), schedule, and combination chemotherapy are determined by the oncologist based on the cancer type, body surface area, and blood counts.
- Never change the dose, schedule, or infusion site yourself.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Gemcitabine is given on a precise schedule by healthcare professionals. If you think a dose may have been missed or delayed, contact your oncology team for instructions. Do not attempt to alter the schedule or receive an extra infusion on your own.
Overdose
Gemcitabine is administered only by healthcare professionals in a clinical setting, so a home-overdose scenario does not apply. Specific overdose-management protocol details were not established from the sources reviewed for this draft. If you have any concern about the dose or infusion you received, tell your oncology team promptly. (1)
Side effects
Gemcitabine can cause serious side effects including myelosuppression, pulmonary toxicity, hemolytic‑uremic syndrome, hepatic toxicity, posterior reversible encephalopathy syndrome, and capillary leak syndrome. Common adverse reactions include nausea/vomiting, anemia, liver‑enzyme elevations, neutropenia, thrombocytopenia, fever, rash, dyspnea, and peripheral edema.
Nausea and vomiting
What to notice: Feeling sick or vomiting, which may occur despite anti‑nausea medication.
What to do: Tell your oncology team if nausea or vomiting is severe, persistent, or interferes with eating and drinking. (1)
Anemia (low red blood cells)
What to notice: Unusual tiredness, weakness, pale skin, shortness of breath, or dizziness.
What to do: Report these symptoms to your oncology team; they will monitor your blood counts and may adjust treatment or provide supportive care. (1)
Neutropenia (low white blood cells)
What to notice: Signs or symptoms of infection or fever.
What to do: Contact your oncology team immediately if you develop a fever or signs of infection; they will check your blood counts and advise on management. (1)
Thrombocytopenia (low platelets)
What to notice: Unusual or prolonged bruising or bleeding.
What to do: Tell your oncology team promptly; they will monitor your platelet count and may delay or adjust therapy. (1)
Fever
What to notice: Elevated temperature without an obvious infection.
What to do: Report any fever to your oncology team, especially if accompanied by other symptoms. (1)
Rash
What to notice: Redness, itching, or skin eruptions.
What to do: Show the rash to your oncology team; do not use creams or ointments without checking with them. (1)
Shortness of breath (dyspnea)
What to notice: New or worsening breathlessness, which could be a sign of pulmonary toxicity.
What to do: Seek immediate medical attention and inform your oncology team. Do not dismiss this as normal fatigue. (1)
Peripheral edema
What to notice: Swelling of the feet, ankles, or legs.
What to do: Mention the swelling to your oncology team; they will assess whether it requires intervention. (1)
Increased liver enzymes or alkaline phosphatase
What to notice: Often detected on blood tests. A specific patient-facing symptom list was not established from the sources reviewed for this draft.
What to do: Your oncology team will monitor liver function regularly. Report anything that feels unusual to your oncology team. (1)
Proteinuria or hematuria
What to notice: Foamy urine or blood in the urine; often found on urine tests.
What to do: Report any changes in urination or colour; your team will check urine tests before and during treatment. (1)
Severe myelosuppression
What to notice: Signs or symptoms of infection, fever, prolonged or unexpected bleeding, bruising, or shortness of breath.
What to do: Contact your oncology team immediately. As directed by your oncology team, the dose may be withheld or reduced and supportive care provided; this is a decision for your oncology team to make, not a self-directed change. (1)
Pulmonary toxicity
What to notice: Unexplained new or worsening shortness of breath, dry cough, or chest tightness; symptoms may appear up to 2 weeks after the last dose.
What to do: Seek emergency medical attention and inform your oncology team immediately. As directed by your oncology team, they will decide whether gemcitabine needs to be stopped. (1)
Hemolytic‑uremic syndrome (HUS)
What to notice: Changes in the colour or volume of your urine, or increased bruising or bleeding. A detailed itemized symptom list for HUS specifically was not found in the sources reviewed for this draft beyond these general counseling points.
What to do: Contact your oncology team urgently. As directed by your oncology team, they will assess kidney function and decide whether gemcitabine needs to be stopped if HUS is confirmed. (1)
Severe hepatic toxicity
What to notice: A specific patient-facing symptom list for severe hepatic toxicity was not found in the sources reviewed for this draft. Report anything that feels unusual to your oncology team.
What to do: Seek immediate medical assessment. As directed by your oncology team and based on blood tests and clinical evaluation, they will decide whether gemcitabine needs to be stopped. (1)
Posterior reversible encephalopathy syndrome (PRES)
What to notice: Severe headache, seizure, sudden confusion, lethargy, high blood pressure, vision changes, or blindness.
What to do: Get emergency medical help. PRES is a serious brain condition; as directed by your emergency and oncology care team, they will decide whether gemcitabine needs to be stopped, alongside supportive care. (1)
Capillary leak syndrome
What to notice: A specific patient-facing symptom list for capillary leak syndrome was not found in the sources reviewed for this draft; do not assume any particular symptom pattern.
What to do: Seek emergency care immediately if you feel seriously unwell in any way during or after treatment. As directed by your oncology team, they will determine whether gemcitabine needs to be discontinued. (1)
Serious warnings
Myelosuppression (low blood counts) — emergency
Symptoms: Signs or symptoms of infection, fever, prolonged or unexpected bleeding, bruising, or shortness of breath.
Action: Contact your oncology team immediately. They will check your blood counts and, as they direct, may hold or reduce the dose. Seek emergency care for high fever, uncontrolled bleeding, or severe symptoms. (1)
Pulmonary toxicity (lung injury) — emergency
Symptoms: New or worsening shortness of breath, dry cough, chest tightness; can happen during or weeks after treatment.
Action: Seek emergency medical attention. Inform the healthcare team you are receiving gemcitabine. As directed by your oncology team, they will assess the need to stop the medicine. (1)
Hemolytic‑uremic syndrome (HUS) / severe kidney damage — emergency
Symptoms: Changes in the colour or volume of your urine, or increased bruising or bleeding. A detailed itemized HUS symptom list was not found in the sources reviewed for this draft beyond these general counseling points.
Action: Get emergency help immediately. HUS is life‑threatening; as directed by your oncology and emergency care team, they will decide on stopping gemcitabine and urgent hospital care. (1)
Severe liver damage — emergency
Symptoms: A specific patient-facing symptom list for severe hepatic toxicity was not found in the sources reviewed for this draft. Liver function is monitored by blood tests before and during treatment.
Action: Seek emergency medical evaluation for anything that feels seriously unwell. As directed by your oncology team, and based on blood tests and clinical evaluation, they will decide whether gemcitabine needs to be discontinued. (1)
Posterior reversible encephalopathy syndrome (PRES) — emergency
Symptoms: Severe headache, seizure, sudden confusion, vision loss, blindness, lethargy, high blood pressure.
Action: Call emergency services immediately. PRES requires urgent treatment; as directed by your emergency and oncology care team, they will decide on stopping gemcitabine alongside supportive care. (1)
Capillary leak syndrome — emergency
Symptoms: A specific patient-facing symptom list was not found in the sources reviewed for this draft; do not assume any particular symptom pattern.
Action: Seek emergency care right away if you feel seriously unwell in any way. This condition can be fatal; as directed by your oncology and emergency care team, they will decide on stopping gemcitabine and provide intensive support. (1)
Hypersensitivity to gemcitabine — emergency
Symptoms: A specific patient-facing allergic-reaction symptom list was not found in the sources reviewed for this draft. The label establishes known hypersensitivity to gemcitabine as a contraindication.
Action: Seek emergency medical help immediately for any reaction you believe may be allergic. As directed by your oncology team, they will decide on any change to future treatment after evaluation. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Other medicines (including chemotherapy) | No formal drug‑interaction studies have been conducted with gemcitabine, per the label. It is used in specified combinations with carboplatin, paclitaxel, or cisplatin depending on indication, each with its own risk profile. | Give your oncology team a complete list of all medicines, supplements, and herbal products before each treatment cycle. Never change or add a medicine without their guidance. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Gemcitabine is Pregnancy Category D. Animal studies showed it is teratogenic, embryotoxic, and fetotoxic (mice and rabbits), meaning it can cause fetal harm if administered during pregnancy. Specific contraception requirements were not established from the sources reviewed for this draft — tell your oncologist immediately about pregnancy, plans for pregnancy, or if you become pregnant during treatment. (1)
Breastfeeding
It is not known whether gemcitabine passes into human milk. Because of the potential for serious adverse reactions in nursing infants, a decision on whether to discontinue nursing or discontinue gemcitabine must be made together with your oncologist, taking into account the importance of the drug to the mother — this is not a decision to make on your own. (1)
Patients with kidney or liver problems
Kidney and liver function are monitored before starting and periodically during treatment. As directed by your oncologist, gemcitabine may be stopped if severe kidney or liver impairment develops. No standard dose‑adjustment table for pre‑existing impairment was found in the sources reviewed for this draft — this remains unresolved rather than confirmed absent; your oncologist will assess your individual risk using current prescribing information. (1)
Pediatric use
No pediatric dosing or safety data were found in the sources reviewed for this draft. This is (1)
Monitoring
Before starting
- Complete blood count (CBC) with differential and platelet count.
- Renal function assessment.
- Hepatic function assessment.
- Specific individual test names beyond these categories, and any pregnancy-testing requirement, were not established from the sources reviewed for this draft.
During treatment
- CBC with differential and platelet count prior to each dose; dose modifications are based on these results.
- Renal function periodically; discontinue gemcitabine for hemolytic‑uremic syndrome or severe kidney injury.
- Hepatic function periodically; discontinue for severe hepatic toxicity.
- Monitor for signs and symptoms of pulmonary toxicity, PRES, capillary leak syndrome, and infusion‑related reactions.
- As directed by institutional protocol and current prescribing information, the oncology team assesses blood counts before each dose and adjusts, withholds, or reschedules treatment accordingly; specific numeric thresholds were not established from the sources reviewed for this draft.
Storage
Gemcitabine for injection is a lyophilized powder that is reconstituted and administered only by healthcare professionals in a clinical setting; it is not stored or handled by patients at home. Specific storage, handling, and disposal instructions were not established from the sources reviewed for this draft.
Professional information
Clinician‑facing context only. Use the current local prescribing information, protocol, and oncology guidelines for the specific indication.
United States
Indication: Advanced ovarian cancer (combination with carboplatin)
Dose summary: Gemcitabine 1000 mg/m² IV over 30 minutes on Days 1 and 8 of each 21‑day cycle.
Renal context: No specific renal-impairment dose-adjustment table was extracted from the sources reviewed for this draft; discontinue gemcitabine for HUS or severe renal impairment as directed by the treating clinician. (1)
United States
Indication: Metastatic breast cancer (combination with paclitaxel)
Dose summary: Gemcitabine 1250 mg/m² IV over 30 minutes on Days 1 and 8 of each 21‑day cycle.
Renal context: No specific renal-impairment dose-adjustment table was extracted from the sources reviewed for this draft; discontinue gemcitabine for HUS or severe renal impairment as directed by the treating clinician. (1)
United States
Indication: Non‑small cell lung cancer (combination with cisplatin) – two options
Dose summary: Option 1: Gemcitabine 1000 mg/m² IV over 30 minutes on Days 1, 8, and 15 of a 28‑day cycle. Option 2: Gemcitabine 1250 mg/m² IV over 30 minutes on Days 1 and 8 of a 21‑day cycle. Both given with cisplatin.
Renal context: No specific renal-impairment dose-adjustment table was extracted from the sources reviewed for this draft; discontinue gemcitabine for HUS or severe renal impairment as directed by the treating clinician. Cisplatin requires its own renal monitoring per its separate label. (1)
United States
Indication: Pancreatic cancer (monotherapy)
Dose summary: Gemcitabine 1000 mg/m² IV over 30 minutes once weekly for up to 7 weeks, followed by a week of rest; subsequent cycles follow the label's schedule. The exact subsequent-cycle pattern was not extracted verbatim from the sources reviewed for this draft.
Renal context: No specific renal-impairment dose-adjustment table was extracted from the sources reviewed for this draft; discontinue gemcitabine for HUS or severe renal impairment as directed by the treating clinician. (1)
Hepatic guidance
No specific hepatic dose-adjustment table was found in the sources reviewed for this draft; the label supports discontinuing gemcitabine for severe hepatic toxicity, as directed by the treating clinician. Liver function should be monitored before and during treatment.
Overdose note
Specific overdose-management protocol details (e.g., antidote availability, monitoring intervals) were not established from the sources reviewed for this draft; manage per institutional protocol and current prescribing information. (1)
Frequently asked questions
Can gemcitabine be given at home?
No. Gemcitabine is an intravenous chemotherapy medicine that must be administered by healthcare professionals in a clinic or hospital. It is never self‑administered. (1)
What should I do if I miss an infusion appointment?
Contact your oncology team immediately for instructions; the schedule may need to be adjusted. Do not try to make up a missed dose on your own. (1)
What are the most serious side effects I need to watch for?
Look out for signs of infection or fever, severe or unexplained bleeding or bruising, new or worsening shortness of breath, and severe headache with confusion, seizure, or vision changes. These require immediate medical attention; your oncology team, as directed, will assess and decide on any change to treatment. (1)
Can I take other medicines during gemcitabine treatment?
Always tell your oncology team about all medicines, including over‑the‑counter products and supplements. No formal interaction studies have been done, so it is important they know everything you are taking. (1)
What is the mechanism of action of gemcitabine?
Gemcitabine is a nucleoside-analog antimetabolite chemotherapy medicine. Mechanism-of-action detail beyond this classification was not established from the sources reviewed for this draft. (1)
What is the generic name of Gemcitabine?
The generic name is gemcitabine. (1)
What class of drug is gemcitabine?
Gemcitabine is classed as: Nucleoside-analog (antimetabolite) chemotherapy. (1)
References
- GEMCITABINE injection, powder, lyophilized, for solution — prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-05 · source 1
- AVGEMSI (GEMCITABINE) INJECTION, SOLUTION [AVYXA PHARMA, LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Gemcitabine Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Gemcitabine — FDA approval record (Drugs@FDA ANDA205242)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- gemcitabine — RxNorm normalized drug concept (RXCUI 12574)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient gemcitabine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- AVGEMSI38 mg/mL · avyxa pharma, llc
- INLEXZO225 mg · janssen biotech, inc
Canada
- GEMCITABINE SUN
- GEMCITABINE FOR INJECTION CONCENTRATE