Pharmacologic class (EPC) · 6 drug pages

Proteasome inhibitor: adverse event reports filed with FDA

109,894 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

109,894
reports across the class: 0.5% of all reports; 6,177
reports, 12 months to June 2026: 7,701 in the 12 months before; 86%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Proteasome inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 109,894 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

6,177 reports arrived in the 12 months to June 2026, down 20% from 7,701 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 86% of the class's reports are marked serious, 18.1% record death among the outcomes and 33.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are plasma cell myeloma (11.8%), off label use (9.6%) and death (6.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
VelcadeBortezomib	brand	37,364	1,239	85.6%	Neuropathy peripheral
Bortezomib	generic	26,908	3,001	97.9%	Plasma cell myeloma
Carfilzomib	generic	11,693	934	96.8%	Plasma cell myeloma
KyprolisCarfilzomib	brand	11,565	393	61.2%	Off label use
Ixazomib	generic	11,365	449	97.1%	Plasma cell myeloma
NinlaroIxazomib	brand	10,999	161	61.2%	Diarrhoea

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Plasma cell myeloma11.8%12,945
Off label useused for a purpose or in a way not on the label9.6%10,525
Deaththe patient died; cause not stated by this term6.9%7,613
Neuropathy peripheralnerve damage in hands or feet6.4%7,009
Diarrhoealoose or frequent stools6.1%6,671
Pneumonialung infection5.1%5,594
Thrombocytopenialow platelets5%5,465
Fatiguetiredness4.6%5,022
Drug ineffectivethe medicine did not work as expected4.2%4,567
Nauseafeeling sick3.9%4,320
Pyrexiafever3.5%3,896
Anaemialow red blood cells3.3%3,654
Neutropenialow neutrophils, a type of white blood cell3.3%3,635
Disease progressionthe disease advanced2.9%3,186
Dyspnoeashortness of breath2.7%2,930
Vomitingbeing sick2.5%2,740
Platelet count decreasedlow platelet count2.5%2,731
Astheniaweakness or lack of energy2.5%2,715
Rashskin rash2.1%2,346
Sepsisa severe body-wide response to infection2.1%2,330
Constipationconstipation2.1%2,276
Infectionan infection, type not specified2%2,251
Acute kidney injurysudden loss of kidney function1.8%2,032
Intentional product use issuedeliberate use not as intended1.7%1,843
Febrile neutropeniafever with low white blood cells1.5%1,692

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death18.1%19,906

Life-threatening5.4%5,955

Hospitalisation (initial or prolonged)33.6%36,921

Disability1.5%1,627

Congenital anomaly0%45

Other serious59.8%65,736

Not serious14%15,402

Patient age

Under 20.1%133

2 to 110.4%483

12 to 170.3%383

18 to 442.7%2,942

45 to 6424.1%26,515

65 to 7422%24,189

75 and over14.5%15,957

Age not given35.8%39,292

Who reported

Physician48.2%52,992

Pharmacist6%6,624

Other health professional29%31,864

Lawyer0%35

Consumer or non-health professional15.7%17,241

Not given1%1,138

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Proteasome inhibitor reports

Which drugs are in the Proteasome inhibitor class on this site?

Velcade, Bortezomib, Carfilzomib, Kyprolis, Ixazomib and Ninlaro. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

109,894 reports through June 2026, 6,177 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

plasma cell myeloma (11.8%), off label use (9.6%), death (6.9%), neuropathy peripheral (6.4%) and diarrhoea (6.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.