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Carfilzomib side effects: what 28,114 FDA adverse event reports show

Carfilzomib · Kyprolis · 1,076 reaction terms · 76,125 drug–reaction co-reports · data 2026-09-14
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Drug class

Proteasome Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Kyprolis

openFDA label

Who reports

28,114 reports · 77% serious · 4,377 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone.

FDA label, Indications and Usage

What it is

Carfilzomib is a proteasome inhibitor.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 5Labeled (related wording) 5Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 21
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,036 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Sars-cov-2 sepsis15524.9
270.6–1,018.2ROR 525.2 · χ² 4,275 / p <1e-300
220.7 EB05 142.0 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Global longitudinal strain abnormal14294.0
158.2–546.3ROR 294.1 · χ² 2,714 / p <1e-300
163.7 EB05 103.7 · IC025 +3.8
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Plasma cell leukaemia119185.3
151.6–226.5ROR 186.1 · χ² 17,273 / p <1e-300
144.8 EB05 124.2 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=119 · 94% cliniciannot reported in cached trials
Plasma cells increased14177.4
99.0–318.0ROR 177.5 · χ² 1,838 / p <1e-300
120.1 EB05 76.0 · IC025 +3.7
3/3 methods agree
Lab value / disease markerserious n=14not reported in cached trials
Myeloma cast nephropathy23142.0
90.9–221.9ROR 142.2 · χ² 2,582 / p <1e-300
108.7 EB05 76.3 · IC025 +4.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=23 · 91% cliniciannot reported in cached trials
Light chain disease23138.6
88.8–216.3ROR 138.7 · χ² 2,528 / p <1e-300
106.6 EB05 74.8 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=23 · ♀ 0% (drug 45%)not reported in cached trials
Plasmacytoma18882.9
71.4–96.4ROR 83.5 · χ² 13,602 / p <1e-300
74.1 EB05 65.6 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=180NCT01568866: 5/463 (1.1%) on Carfilzomib (serious AE)
Plasma cell myeloma recurrent32281.5
72.6–91.3ROR 82.4 · χ² 22,968 / p <1e-300
73.1 EB05 66.7 · IC025 +5.9
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=305not reported in cached trials
Refractory cancer1867.5
41.7–109.4ROR 67.5 · χ² 1,020 / p 4e-224
58.3 EB05 39.0 · IC025 +3.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=18not reported in cached trials
Light chain analysis increased8466.5
53.2–83.1ROR 66.6 · χ² 4,906 / p <1e-300
60.2 EB05 50.2 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious n=46not reported in cached trials
Plasma cell myeloma3,02862.6
60.4–64.8ROR 70.0 · χ² 169,373 / p <1e-300
57.7 EB05 56.0 · IC025 +5.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious PRR 45.1 · 94% clinicianNCT01818752: 2/470 (0.4%) on Carfilzomib (serious AE)
Blood stem cell harvest failure1053.6
28.2–101.9ROR 53.7 · χ² 434 / p 1e-96
46.0 EB05 26.7 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=9not reported in cached trials
Monoclonal immunoglobulin increased1850.7
31.4–81.7ROR 50.7 · χ² 774 / p 1e-170
45.4 EB05 30.4 · IC025 +3.6
3/3 methods agree
Lab value / disease markerserious n=15not reported in cached trials
Light chain analysis abnormal1350.0
28.5–87.7ROR 50.0 · χ² 540 / p 1e-119
44.1 EB05 27.4 · IC025 +3.2
3/3 methods agree
Reporting / coding artifactserious n=10not reported in cached trials
Paraproteinaemia1845.5
28.2–73.2ROR 45.5 · χ² 696 / p 1e-153
41.1 EB05 27.5 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Microangiopathic haemolytic anaemia3939.4
28.6–54.4ROR 39.5 · χ² 1,350 / p 8e-296
36.9 EB05 28.1 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=39 · 100% cliniciannot reported in cached trials
Minimal residual disease2338.4
25.3–58.4ROR 38.4 · χ² 761 / p 7e-168
35.6 EB05 25.0 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=21 · 100% cliniciannot reported in cached trials
Hyperviscosity syndrome1437.8
22.1–64.7ROR 37.8 · χ² 443 / p 1e-98
34.5 EB05 21.8 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Morganella infection1437.3
21.8–63.8ROR 37.3 · χ² 436 / p 3e-97
34.0 EB05 21.5 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Bronchopneumopathy1633.7
20.4–55.6ROR 33.7 · χ² 455 / p 4e-101
31.2 EB05 20.3 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=16NCT01568866: 1/456 (0.2%) on Carfilzomib (serious AE)
Thrombotic microangiopathy41533.4
30.2–36.8ROR 33.8 · χ² 12,432 / p <1e-300
31.9 EB05 29.4 · IC025 +4.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 23.8 · 98% clinicianNCT01568866: 2/463 (0.4%) on Carfilzomib (serious AE)
Monoclonal immunoglobulin present3232.5
22.8–46.3ROR 32.6 · χ² 906 / p 2e-199
30.7 EB05 22.8 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=12not reported in cached trials
Haemolytic uraemic syndrome9631.8
25.9–39.0ROR 31.9 · χ² 2,715 / p <1e-300
30.4 EB05 25.6 · IC025 +4.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=96 · 97% clinicianNCT01818752: 1/474 (0.2%) on Carfilzomib (serious AE)
Body dysmorphic disorder1531.3
18.7–52.5ROR 31.3 · χ² 394 / p 7e-88
29.1 EB05 18.7 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
B-cell aplasia1030.5
16.2–57.4ROR 30.5 · χ² 246 / p 8e-56
27.8 EB05 16.0 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Infestation1029.8
15.8–56.0ROR 29.8 · χ² 240 / p 2e-54
27.2 EB05 15.6 · IC025 +2.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=10not reported in cached trials
Therapy partial responder55528.5
26.2–31.0ROR 29.1 · χ² 14,164 / p <1e-300
27.5 EB05 25.6 · IC025 +4.6
3/3 methods agree
Reporting / coding artifactserious PRR 23.7 · 99% cliniciannot reported in cached trials
Osteolysis7327.5
21.8–34.7ROR 27.6 · χ² 1,771 / p <1e-300
26.4 EB05 21.7 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=72 · 93% cliniciannot reported in cached trials
Bronchial haemorrhage1126.9
14.8–49.2ROR 27.0 · χ² 241 / p 1e-54
24.9 EB05 14.6 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Bone marrow infiltration1326.0
14.9–45.1ROR 26.0 · χ² 278 / p 1e-62
24.2 EB05 14.9 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Cerebral toxoplasmosis3024.7
17.2–35.5ROR 24.7 · χ² 637 / p 7e-141
23.6 EB05 17.3 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=30 · 97% cliniciannot reported in cached trials
B-cell type acute leukaemia2324.6
16.3–37.3ROR 24.7 · χ² 482 / p 4e-107
23.5 EB05 16.4 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=23 · 100% cliniciannot reported in cached trials
Intercepted product preparation error36723.1
20.9–25.7ROR 23.4 · χ² 7,522 / p <1e-300
22.4 EB05 20.6 · IC025 +4.3
3/3 methods agree
Not in label — unassessed94% cliniciannot reported in cached trials
Tumour lysis syndrome24221.2
18.7–24.1ROR 21.4 · χ² 4,515 / p <1e-300
20.6 EB05 18.5 · IC025 +4.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 15.5 · 97% clinicianNCT01818752: 3/474 (0.6%) on Carfilzomib (serious AE)
Pneumonia influenzal3321.1
15.0–29.9ROR 21.2 · χ² 596 / p 6e-132
20.4 EB05 15.1 · IC025 +3.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=33 · 100% clinicianNCT01568866: 1/463 (0.2%) on Carfilzomib (serious AE)

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Carfilzomib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (8 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Plasma cell myeloma3,02862.6
60.4–64.8ROR 70.0 · χ² 169,373 / p <1e-300
57.7 EB05 56.0 · IC025 +5.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious PRR 45.1 · 94% clinicianNCT01818752: 2/470 (0.4%) on Carfilzomib (serious AE)
Off label use (used outside approved label)2,3942.1
2.0–2.1ROR 2.2 · χ² 1,358 / p 2e-297
2.1 EB05 2.0 · IC025 +1.0Reporting / coding artifactserious PRR 1.9 · 92% cliniciannot reported in cached trials
Death1,7631.5
1.5–1.6ROR 1.6 · χ² 334 / p 7e-75
1.5 EB05 1.5 · IC025 +0.5Outcome field, not a reactionserious PRR 1.1 · 91% clinicianNCT01818752: 1/470 (0.2%) on Carfilzomib (serious AE)
Thrombocytopenia (low platelets)1,54310.5
10.0–11.0ROR 11.0 · χ² 13,064 / p <1e-300
10.3 EB05 9.9 · IC025 +3.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 7.7 · 95% clinicianNCT01818752: 5/474 (1.1%) on Carfilzomib (serious AE)
Fatigue (tiredness)1,5421.5
1.4–1.6ROR 1.5 · χ² 249 / p 2e-56
1.5 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.2NCT01818752: 1/474 (0.2%) on Carfilzomib (serious AE)
Pneumonia (lung infection)1,3893.2
3.1–3.4ROR 3.3 · χ² 2,140 / p <1e-300
3.2 EB05 3.1 · IC025 +1.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.5 · 91% clinicianNCT01818752: 46/474 (9.7%) on Carfilzomib (serious AE)
Pyrexia (fever)1,1672.5
2.4–2.7ROR 2.6 · χ² 1,082 / p 2e-237
2.5 EB05 2.4 · IC025 +1.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.1NCT01818752: 16/474 (3.4%) on Carfilzomib (serious AE)
Diarrhoea (diarrhea)1,1231.3
1.2–1.4ROR 1.3 · χ² 81 / p 1e-19
1.3 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
serious PRR 1.3NCT01818752: 3/474 (0.6%) on Carfilzomib (serious AE)
Dyspnoea (shortness of breath)1,1171.5
1.4–1.6ROR 1.5 · χ² 174 / p 5e-40
1.5 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.2NCT01818752: 9/474 (1.9%) on Carfilzomib (serious AE)
Anaemia (low red blood cells)1,1174.4
4.1–4.6ROR 4.5 · χ² 2,924 / p <1e-300
4.4 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.4 · 91% clinicianNCT01818752: 11/474 (2.3%) on Carfilzomib (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))1,1146.2
5.8–6.5ROR 6.4 · χ² 4,817 / p <1e-300
6.1 EB05 5.8 · IC025 +2.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.6 · 95% clinicianNCT01818752: 4/474 (0.8%) on Carfilzomib (serious AE)
Nausea1,0821.0
1.0–1.1ROR 1.0 · χ² 1 / p 0.230
1.0 EB05 1.0 · IC025 -0.1
PRR-only: not supported by EBGM or IC
Labeled adverse reaction
exact term
serious PRR 1.0NCT01818752: 2/474 (0.4%) on Carfilzomib (serious AE)
Acute kidney injury (sudden kidney damage)8624.2
4.0–4.5ROR 4.3 · χ² 2,134 / p <1e-300
4.2 EB05 4.0 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.1 · 96% clinicianNCT01818752: 19/474 (4.0%) on Carfilzomib (serious AE)
Drug ineffective (drug did not work)8540.5
0.5–0.5ROR 0.5 · χ² 502 / p 2e-111
0.5 EB05 0.5 · IC025 -1.2
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 0.8not reported in cached trials
Hypertension (high blood pressure)7142.5
2.3–2.7ROR 2.6 · χ² 655 / p 8e-145
2.5 EB05 2.4 · IC025 +1.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 1.9 · 92% clinicianNCT01818752: 1/474 (0.2%) on Carfilzomib (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Carfilzomib?

In FDA FAERS, the most frequently co-reported reaction terms for Carfilzomib are plasma cell myeloma, thrombocytopenia, fatigue, pneumonia, pyrexia, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Carfilzomib have an FDA boxed warning?

No. The FDA label retrieved for Carfilzomib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Carfilzomib causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.