What the label lists and what reports show
Gemcitabine side effects
Gemcitabine's FDA label: “The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash …” FAERS holds 53,011 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is thrombocytopenia (3,706 reports).
- Generic listed
Check it at the source: the gemcitabine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INLEXZO?The most common side effects of INLEXZO include: frequent need to pass urine more often than usual urinary tract infection pain or burning sensation when passing urine urgent need to pass urine decreased hemoglobin increased lipase pain in the urinary tract (felt in the lower stomach area or lower back) decreased lymphocytes blood in urine increased creatinine increased potassium increased aspartate aminotransferase decreased sodium bladder irritation increased alanine transaminase INLEXZO may cause fertility problems in males, which may affect your ability to have children. It is unknown if these side effects of fertility are reversible. Talk to your healthcare provider if this is a problem for you. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INLEXZO. […]
Source: FDA drug label (INLEXZO), Janssen Biotech, Inc, effective September 11, 2025 (SPL set 3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema.
Table 11: Selected Adverse Reactions Occurring in ≥10% of Patients Receiving Gemcitabine with Cisplatin and at Higher Incidence than in Patients Receiving Single Agent Cisplatin [Between Arm Difference of ≥5% (All…
| Reaction | All Grades (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|---|---|---|
| Nausea | 93 | 25 | 2 | 87 | 20 | <1 |
| Vomiting | 78 | 11 | 12 | 71 | 10 | 9 |
| Alopecia | 53 | 1 | 0 | 33 | 0 | 0 |
| Neuro Motor | 35 | 12 | 0 | 15 | 3 | 0 |
| Diarrhea | 24 | 2 | 2 | 13 | 0 | 0 |
| Neuro Sensory | 23 | 1 | 0 | 18 | 1 | 0 |
| Infection | 18 | 3 | 2 | 12 | 1 | 0 |
| Fever | 16 | 0 | 0 | 5 | 0 | 0 |
| Neuro Cortical | 16 | 3 | 1 | 9 | 1 | 0 |
| Neuro Mood | 16 | 1 | 0 | 10 | 1 | 0 |
| Local | 15 | 0 | 0 | 6 | 0 | 0 |
| Neuro Headache | 14 | 0 | 0 | 7 | 0 | 0 |
| Stomatitis | 14 | 1 | 0 | 5 | 1 | 0 |
| Hemorrhage | 14 | 1 | 0 | 4 | 0 | 0 |
| Hypotension | 12 | 1 | 0 | 7 | 1 | 0 |
| Rash | 11 | 0 | 0 | 3 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications ( 4 )] Schedule-Dependent Toxicity [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.3 )] Hemolytic Uremic Syndrome [see Warnings and Precautions ( 5.4 )] Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions ( 5.7 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.8 )] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.9 )] The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800- 551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set c550dd16-a5e8-44be-87f2-210c15bbb513), via openFDA; the full label on DailyMed
What do FAERS reports show?
53,011 reports list gemcitabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,971 are coded as a death and 21,055 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Gemcitabine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions