What the label lists and what reports show
Carfilzomib side effects
Carfilzomib's FDA label: “The most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.” FAERS holds 28,118 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is plasma cell myeloma (3,028 reports).
- No generic listed
Check it at the source: the carfilzomib FDA label on DailyMed (effective June 18, 2025, Onyx Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.
Table 8: Adverse Reactions (≥ 10%) Occurring in Cycles 1–12 in Patients Who Received KRd (20/27 mg/m 2 Regimen) in ASPIRE
| Reaction | Any Grade | ≥ Grade 3 | Any Grade | ≥ Grade 3 |
|---|---|---|---|---|
| Anemia | 138 (35) | 53 (14) | 127 (33) | 47 (12) |
| Neutropenia | 124 (32) | 104 (27) | 115 (30) | 89 (23) |
| Thrombocytopenia | 100 (26) | 58 (15) | 75 (19) | 39 (10) |
| Diarrhea | 119 (30) | 8 (2) | 106 (27) | 12 (3) |
| Constipation | 68 (17) | 0 (0) | 55 (14) | 1 (0) |
| Nausea | 63 (16) | 1 (0) | 43 (11) | 3 (1) |
| Fatigue | 113 (29) | 23 (6) | 107 (28) | 20 (5) |
| Pyrexia | 93 (24) | 5 (1) | 64 (17) | 1 (0) |
| Edema peripheral | 59 (15) | 3 (1) | 48 (12) | 2 (1) |
| Asthenia | 54 (14) | 11 (3) | 49 (13) | 7 (2) |
| Upper respiratory tract infection | 87 (22) | 7 (2) | 54 (14) | 4 (1) |
| Bronchitis | 55 (14) | 5 (1) | 40 (10) | 2 (1) |
| Viral upper respiratory tract infection | 55 (14) | 0 (0) | 44 (11) | 0 (0) |
| Pneumonia Pneumonia includes pneumonia and bronchopneumonia. | 54 (14) | 35 (9) | 43 (11) | 27 (7) |
| Hypokalemia | 78 (20) | 22 (6) | 35 (9) | 12 (3) |
| Hypocalcemia | 55 (14) | 10 (3) | 39 (10) | 5 (1) |
| Hyperglycemia | 43 (11) | 18 (5) | 33 (9) | 15 (4) |
| Muscle spasms | 92 (24) | 3 (1) | 75 (19) | 3 (1) |
| Back pain | 41 (11) | 4 (1) | 54 (14) | 6 (2) |
| Peripheral neuropathies Peripheral neuropathies includes peripheral neuropathy,… | 43 (11) | 7 (2) | 39 (10) | 4 (1) |
| Insomnia | 64 (16) | 6 (2) | 51 (13) | 8 (2) |
| Cough Cough includes cough and productive cough. | 93 (24) | 2 (1) | 54 (14) | 0 (0) |
| Dyspnea Dyspnea includes dyspnea and dyspnea exertional. | 71 (18) | 8 (2) | 61 (16) | 6 (2) |
| Rash | 45 (12) | 5 (1) | 54 (14) | 5 (1) |
| Embolic and thrombotic events Embolic and thrombotic events, venous includes deep vein… | 49 (13) | 16 (4) | 23 (6) | 9 (2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Toxicities [see Warnings and Precautions (5.1) ] Acute Renal Failure [see Warnings and Precautions (5.2) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Pulmonary Hypertension [see Warnings and Precautions (5.5) ] Dyspnea [see Warnings and Precautions (5.6) ] Hypertension [see Warnings and Precautions (5.7) ] Venous Thrombosis [see Warnings and Precautions (5.8) ] Infusion-Related Reactions [see Warnings and Precautions (5.9) ] Hemorrhage [see Warnings and Precautions (5.10) ] Thrombocytopenia [see Warnings and Precautions (5.11) ] Hepatic Toxicity and Hepatic Failure [see Warnings and Precautions (5.12) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.13) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.14) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.15) ] The most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. …
Source: FDA drug label, Onyx Pharmaceuticals, Inc., effective June 18, 2025 (SPL set ea66eb30-e665-4693-99a1-a9d3b4bbe2d6), via openFDA; the full label on DailyMed
What do FAERS reports show?
28,118 reports list carfilzomib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,377 are coded as a death and 9,417 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Carfilzomib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions