Oxaliplatin: adverse event reports filed with FDA

64,129

reports as suspect product

0.3% of all reports · about 2,851 a year

6,375

reports, 12 months to June 2026

6,419 in the 12 months before

97.7%

marked serious by the reporter

97.4% across the class

13.3%

record death among outcomes, as reported

8,510 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Oxaliplatin reports recording the termmedian drug in platinum-based drug

1. Diarrhoealoose or frequent stools9.4%6,059
2. Nauseafeeling sick7.6%4,855
3. Vomitingbeing sick6.2%3,998
4. Neuropathy peripheralnerve damage in hands or feet6.2%3,991
5. Neutropenialow neutrophils, a type of white blood cell6.1%3,904
6. Off label useused for a purpose or in a way not on the label5.9%3,772
7. Disease progressionthe disease advanced5.8%3,694
8. Thrombocytopenialow platelets5.2%3,330
9. Dyspnoeashortness of breath4.5%2,913
10. Pyrexiafever4.1%2,623
11. Fatiguetiredness3.7%2,395
12. Anaemialow red blood cells3.4%2,185
13. Astheniaweakness or lack of energy3.2%2,071
14. Drug ineffectivethe medicine did not work as expected3%1,908
15. Decreased appetitereduced appetite2.8%1,799
16. Abdominal painstomach or belly pain2.8%1,778
17. Febrile neutropeniafever with low white blood cells2.6%1,659
18. Paraesthesiatingling or pins and needles2.4%1,556
19. Myelosuppression2.4%1,518
20. Malignant neoplasm progression2.2%1,440
21. Neurotoxicity2.2%1,379
22. Deaththe patient died; cause not stated by this term2.1%1,352
23. Erythemaskin redness2.1%1,345
24. Dehydrationdehydration2.1%1,335
25. Hypertensionhigh blood pressure2%1,291
26. Hypotensionlow blood pressure2%1,287
27. Rashskin rash2%1,284
28. Malaisegeneral feeling of being unwell2%1,254
29. Leukopenialow white blood cells1.9%1,219
30. Acute kidney injurysudden loss of kidney function1.8%1,180

Top 30 of 3,208 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the platinum-based drug class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 230,969 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 16.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 64,129 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxaliplatin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the platinum-based drug class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Oxaliplatin as a suspect or interacting product; reports listing it only as a concomitant medication (12,313) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.