Carfilzomib: adverse event reports filed with FDA

11,693

reports as suspect product

0.1% of all reports · about 755 a year

934

reports, 12 months to June 2026

1,454 in the 12 months before

96.8%

marked serious by the reporter

86% across the class

18.7%

record death among outcomes, as reported

2,186 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 Carfilzomib reports recording the termmedian drug in proteasome inhibitor

1. Plasma cell myeloma13.8%1,615
2. Thrombocytopenialow platelets8.8%1,024
3. Off label useused for a purpose or in a way not on the label7.8%907
4. Deaththe patient died; cause not stated by this term6.2%724
5. Pneumonialung infection6.2%722
6. Neutropenialow neutrophils, a type of white blood cell6.1%709
7. Anaemialow red blood cells6%701
8. Pyrexiafever4.9%575
9. Acute kidney injurysudden loss of kidney function4.9%568
10. Therapy partial responder4.1%482
11. Infectionan infection, type not specified3.9%457
12. Diarrhoealoose or frequent stools3.9%454
13. Drug ineffectivethe medicine did not work as expected3.8%446
14. Dyspnoeashortness of breath3.4%395
15. Plasma cell myeloma refractory3.3%388
16. Sepsisa severe body-wide response to infection3.3%387
17. Nauseafeeling sick3.2%377
18. Hypertensionhigh blood pressure3.1%364
19. Disease progressionthe disease advanced2.9%344
20. Fatiguetiredness2.9%339
21. Covid-19COVID-19 infection2.8%329
22. Febrile neutropeniafever with low white blood cells2.6%301
23. Cardiac failureheart failure2.5%293
24. Neuropathy peripheralnerve damage in hands or feet2.3%269
25. Thrombotic microangiopathy2.2%257
26. Pulmonary embolisma blood clot in the lung2.1%247
27. Pancytopenialow counts of all blood cells2.1%241
28. Therapy non-responderthe treatment did not work2%236
29. Vomitingbeing sick2%230
30. Leukopenialow white blood cells1.9%223

Top 30 of 1,168 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 6 drugs in the proteasome inhibitor 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 109,894 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. 30.4% 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 11,693 reports.

Drugs most often listed in the same reports

Other products listed in reports where Carfilzomib 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 proteasome inhibitor 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 Carfilzomib as a suspect or interacting product; reports listing it only as a concomitant medication (1,765) 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.