Gemcitabine: uses, dosing, side effects & brands
Gemcitabine is a nucleoside metabolic inhibitor sold in the U.S. under 4 brand and generic names, for breast neoplasms, non-small-cell lung carcinoma and ovarian neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Nucleoside Metabolic Inhibitor
- Treats (across its forms)
- Breast Neoplasms, Non-Small-Cell Lung Carcinoma and Ovarian Neoplasms
- Available as
- Injectable · Solution · System
- Sold as
- 4 products — Gemcitabine Hydrochloride, Gemzar and Infugem, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $600 for a 30-count supply — not your price
How Inlexzo is dosed
From the FDA label for Inlexzo (application NDA219683). Other gemcitabine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For Intravesical Administration Only Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks up to 6 months (8 doses), followed by once every 12 weeks (6 doses). ( 2.2 ) Insert into the bladder using the co-packaged urinary catheter and stylet only. ( 2.1 ) Remove INLEXZO after each 3-week indwelling period. ( 2.2 ) See Full Prescribing Information and Instructions for Use for insertion and removal procedures. ( 2.3 ) 2.1 Important Administration Instructions Administer INLEXZO intravesically only. Do NOT administer by any other route. INLEXZO is co-packaged with a urinary catheter and stylet used to insert INLEXZO through the urinary catheter into the bladder. Administer using the co-packaged urinary catheter and stylet only. INLEXZO should be inserted and removed by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion and removal instructions before attempting insertion or removal of INLEXZO. Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO insertion and removal. 2.2 Recommended Dosage Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity. Remove…
Everything below is the FDA label for Inlexzo (system). Gemcitabine is also sold as injectable and solution, and those are different medicines to take — follow the label for the one you were prescribed.
Inlexzo side effects
The most common (>15%) adverse reactions, including laboratory abnormalities, are urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) 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. The safety of INLEXZO monotherapy was evaluated in Cohort 2 of SunRISe-1, a multi-center, open-label study in 85 adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors [see Clinical Studies (14.1) ]. Patients received INLEXZO (225 mg of gemcitabine) inserted into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months, or until unacceptable toxicity, disease persistence, recurrence, or progression [see Dosage and Administration (2.2) ] . The median number of doses of INLEXZO administered to patients was 9…
Who shouldn’t take Inlexzo
INLEXZO is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ] . Prior hypersensitivity reactions to gemcitabine or any component of the product. Perforation of the bladder ( 4 , 5.1 ) Prior hypersensitivity reaction to gemcitabine or any component of the product ( 4 )
Every gemcitabine product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $600 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $600 | View → | |
| 3 | Not yet rated | Prescription | Solution | Generic | $600 | View → | |
| 4 | Not yet rated | Prescription | System | Generic | $600 | View → |
Gemcitabine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Gemcitabine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for gemcitabine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMost sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent gemcitabine therapy with an appropriate period of breastfeeding abstinence; the manufacturer recommends an abstinence period of at least 1 week after the last dose. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.
National Institute of Child Health and Human Development, record revised June 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about gemcitabine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 15,388 reports naming gemcitabine, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- myelosuppression1,029 reports
- thrombocytopenia929 reports
- malignant neoplasm progression887 reports
- neutropenia846 reports
- anaemia823 reports
- pyrexia795 reports
- nausea758 reports
- vomiting615 reports
Read these as a signal, not a rate. A report does not mean gemcitabine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Inlexzo?
Inlexzo (Gemcitabine Hydrochloride) is a nucleoside metabolic inhibitor used to treat Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Ovarian Neoplasms, Pancreatic Ductal Carcinoma.
What kind of drug is gemcitabine?
The FDA classifies gemcitabine as a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take gemcitabine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run gemcitabine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is gemcitabine sold under?
We track 4 gemcitabine-containing products in the U.S.: Gemcitabine Hydrochloride, Gemzar, Infugem and Inlexzo. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does gemcitabine come in?
Across the brands we track, gemcitabine is currently marketed as injectable, solution and system, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic gemcitabine?
Yes. Our catalog lists 1 generic gemcitabine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has gemcitabine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions gemcitabine. The most recent: Gemcitabine Injection (Jun 10, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Gemcitabine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gemcitabine
- MLA
- “Gemcitabine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gemcitabine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for gemcitabine on DailyMed (NIH) ↗.