Carboplatin: adverse event reports filed with FDA

102,372

reports as suspect product

0.5% of all reports · about 4,551 a year

11,835

reports, 12 months to June 2026

11,643 in the 12 months before

97.1%

marked serious by the reporter

97.4% across the class

15.1%

record death among outcomes, as reported

15,423 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 Carboplatin reports recording the termmedian drug in platinum-based drug

1. Neutropenialow neutrophils, a type of white blood cell6.6%6,741
2. Off label useused for a purpose or in a way not on the label6.5%6,621
3. Anaemialow red blood cells6.3%6,472
4. Febrile neutropeniafever with low white blood cells5.9%6,019
5. Nauseafeeling sick5.9%6,017
6. Thrombocytopenialow platelets5.3%5,439
7. Diarrhoealoose or frequent stools5.1%5,266
8. Disease progressionthe disease advanced5%5,117
9. Malignant neoplasm progression4.8%4,906
10. Vomitingbeing sick4.4%4,489
11. Dyspnoeashortness of breath4.3%4,396
12. Pyrexiafever4%4,045
13. Fatiguetiredness3.6%3,712
14. Drug ineffectivethe medicine did not work as expected3.6%3,684
15. Pancytopenialow counts of all blood cells3.4%3,440
16. Myelosuppression3.3%3,365
17. Astheniaweakness or lack of energy3.2%3,289
18. Pneumonialung infection2.8%2,850
19. Deaththe patient died; cause not stated by this term2.5%2,552
20. Sepsisa severe body-wide response to infection2.4%2,474
21. Product use in unapproved indicationused for a purpose not on the label2.4%2,410
22. Acute kidney injurysudden loss of kidney function2.3%2,371
23. Decreased appetitereduced appetite2.3%2,354
24. Rashskin rash2.3%2,331
25. Neutrophil count decreased2.3%2,319
26. Neuropathy peripheralnerve damage in hands or feet2.2%2,222
27. Platelet count decreasedlow platelet count2.1%2,140
28. White blood cell count decreasedlow white cell count2.1%2,127
29. Leukopenialow white blood cells2%2,058
30. Dehydrationdehydration2%2,025

Top 30 of 4,314 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. 22.8% 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 102,372 reports.

Drugs most often listed in the same reports

Other products listed in reports where Carboplatin 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 Carboplatin as a suspect or interacting product; reports listing it only as a concomitant medication (25,724) 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.