What the label lists and what reports show
Vinorelbine side effects
Vinorelbine's FDA label: “Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE …” FAERS holds 6,869 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 malignant neoplasm progression (699 reports).
- Generic listed
- Boxed warning
Check it at the source: the vinorelbine FDA label on DailyMed (effective August 16, 2024, Sagent Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 3: Adverse Reactions Experienced by ≥ 10% of Patients on Vinorelbine plus Cisplatin versus Single Agent Cisplatin *
| Reaction | All Grades (%) | Grades 3 - 4 (%) | All Grades (%) | Grades 3-4 (%) |
|---|---|---|---|---|
| Neutropenia | 89 | 82 | 26 | 5 |
| Anemia | 89 | 24 | 72 | <8 |
| Leukopenia | 88 | 58 | 31 | <1 |
| Thrombocytopenia | 29 | 5 | 21 | <2 |
| Blood creatinine increased | 37 | 4 | 28 | <5 |
| Malaise/Fatigue/Lethargy | 67 | 12 | 49 | 8 |
| Vomiting | 60 | 13 | 60 | 14 |
| Nausea | 58 | 14 | 57 | 12 |
| Decreased appetite | 46 | 0 | 37 | 0 |
| Constipation | 35 | 3 | 16 | 1 |
| Alopecia | 34 | 0 | 14 | 0 |
| Weight decreased | 34 | 1 | 21 | <1 |
| Fever without infection | 20 | 2 | 4 | 0 |
| Hearing impaired | 18 | 4 | 18 | <4 |
| Injection site reaction | 17 | <1 | 1 | 0 |
| Diarrhea | 17 | <3 | 11 | <2 |
| Paraesthesia | 17 | <1 | 10 | <1 |
| Taste alterations | 17 | 0 | 15 | 0 |
| Peripheral numbness | 11 | 2 | 7 | <1 |
| Myalgia/Arthralgia | 12 | <1 | 3 | <1 |
| Phlebitis/Thrombosis/Embolism | 10 | 3 | <1 | <1 |
| Weakness | 12 | <3 | 7 | 2 |
| Infection | 11 | <6 | <1 | <1 |
| Respiratory tract infection | 10 | <5 | 3 | 3 |
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: Myelosuppression [see Warnings and Precautions ( 5.1 )] Hepatic Toxicity [see Warnings and Precautions ( 5.2 )] Severe Constipation and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Injury [see Warnings and Precautions ( 5.4 )] Neurologic Toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in clinical practice. …
Source: FDA drug label, Sagent Pharmaceuticals, effective August 16, 2024 (SPL set 10a70995-e04d-4044-b1dc-c9aa27460397), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,869 reports list vinorelbine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,452 are coded as a death and 2,181 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 20 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?
- Vinorelbine: 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