What the label lists and what reports show
Oxaliplatin side effects
Oxaliplatin's FDA label: “Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis.” FAERS holds 73,749 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 diarrhoea (6,869 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the oxaliplatin FDA label on DailyMed (effective August 24, 2026, Gland Pharma Limited); 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 oxaliplatin injection ?Oxaliplatin injection can cause serious side effects, including: See “What is the most important information I should know about oxaliplatin injection?” Nerve problems. Oxaliplatin injection can affect how your nerves work and make you feel. Nerve problems may happen with the first treatment or within two days after your treatment with oxaliplatin injection. Nerve problems may last a short time (acute) or may become persistent. Symptoms may improve after stopping treatment with oxaliplatin injection. Exposure to cold or cold objects may cause or worsen nerve problems. […]
Source: FDA drug label, Gland Pharma Limited, effective August 24, 2026 (SPL set a6f89dc3-a594-4b5b-8728-272e20c1ecb5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | All Grades (%) | Grades 3 to 4 (%) | All Grades (%) | Grades 3 to 4 (%) | All Grades (%) | Grades 3 to 4 (%) |
|---|---|---|---|---|---|---|
| Neuropathy | 82 | 19 | 18 | 2 | 69 | 7 |
| Paresthesias | 77 | 18 | 16 | 2 | 62 | 6 |
| Pharyngo-laryngeal Dysesthesias | 38 | 2 | 1 | 0 | 28 | 1 |
| Neuro-sensory | 12 | 1 | 2 | 0 | 9 | 1 |
| Neuro NOS | 1 | 0 | 1 | 0 | 1 | 0 |
| Nausea | 71 | 6 | 67 | 15 | 83 | 19 |
| Diarrhea | 56 | 12 | 65 | 29 | 76 | 25 |
| Vomiting | 41 | 4 | 43 | 13 | 64 | 23 |
| Stomatitis | 38 | 0 | 25 | 1 | 19 | 1 |
| Anorexia | 35 | 2 | 25 | 4 | 27 | 5 |
| Constipation | 32 | 4 | 27 | 2 | 21 | 2 |
| Diarrhea-colostomy | 13 | 2 | 16 | 7 | 16 | 3 |
| Gastrointestinal NOS | 5 | 2 | 4 | 2 | 3 | 2 |
| Fatigue | 70 | 7 | 58 | 11 | 66 | 16 |
| Abdominal Pain | 29 | 8 | 31 | 7 | 39 | 10 |
| Myalgia | 14 | 2 | 6 | 0 | 9 | 2 |
| Pain | 7 | 1 | 5 | 1 | 6 | 1 |
| Abnormal Vision | 5 | 0 | 2 | 1 | 6 | 1 |
| Neuralgia | 5 | 0 | 0 | 0 | 2 | 1 |
| Cough | 35 | 1 | 25 | 2 | 17 | 1 |
| Dyspnea | 18 | 7 | 14 | 3 | 11 | 2 |
| Hiccups | 5 | 1 | 2 | 0 | 3 | 2 |
| Hyperglycemia | 14 | 2 | 11 | 3 | 12 | 3 |
| Hypokalemia | 11 | 3 | 7 | 4 | 6 | 2 |
| Dehydration | 9 | 5 | 16 | 11 | 14 | 7 |
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 labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2) ] Severe Myelosuppression [see Warnings and Precautions (5.3) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.4) ] Pulmonary Toxicity [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions (5.7) ] Rhabdomyolysis [see Warnings and Precautions (5.8) ] Hemorrhage [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 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. …
Source: FDA drug label, Gland Pharma Limited, effective August 24, 2026 (SPL set a6f89dc3-a594-4b5b-8728-272e20c1ecb5), via openFDA; the full label on DailyMed
What do FAERS reports show?
73,749 reports list oxaliplatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10,724 are coded as a death and 29,031 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, 15 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?
- Oxaliplatin: 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