What the label lists and what reports show

Bortezomib side effects

Bortezomib's FDA label: “Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and …” FAERS holds 88,912 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 (9,117 reports).

Generic listed

Check it at the source: the bortezomib FDA label on DailyMed (effective February 27, 2023, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

Table 12: Most Commonly Reported Adverse Reactions (≥5%) with Grades 3 and ≥4 Intensity in the Previously Untreated Mantle Cell Lymphoma Study

Body System Adverse Reactions	All n (%)	Toxicity Grade 3 n (%)	Toxicity Grade ≥4 n (%)	All n (%)	Toxicity Grade 3 n (%)	Toxicity Grade ≥4 n (%)
Neutropenia	209 (87)	32 (13)	168 (70)	172 (71)	31 (13)	125 (52)
Leukopenia	116 (48)	34 (14)	69 (29)	87 (36)	39 (16)	27 (11)
Anemia	106 (44)	27 (11)	4 (2)	71 (29)	23 (10)	4 (2)
Thrombocytopenia	172 (72)	59 (25)	76 (32)	42 (17)	9 (4)	3 (1)
Febrile neutropenia	41 (17)	24 (10)	12 (5)	33 (14)	17 (7)	15 (6)
Lymphopenia	68 (28)	25 (10)	36 (15)	28 (12)	15 (6)	2 (1)
neuropathy Represents High Level Term Peripheral Neuropathies NEC.	71 (30)	17 (7)	1 (<1)	65 (27)	10 (4)	0
Hypoesthesia	14 (6)	3 (1)	0	13 (5)	0	0
Paresthesia	14 (6)	2 (1)	0	11 (5)	0	0
Neuralgia	25 (10)	9 (4)	0	1 (<1)	0	0
Fatigue	43 (18)	11 (5)	1 (<1)	38 (16)	5 (2)	0
Pyrexia	48 (20)	7 (3)	0	23 (10)	5 (2)	0
Asthenia	29 (12)	4 (2)	1 (<1)	18 (7)	1 (<1)	0
Edema peripheral	16 (7)	1 (<1)	0	13 (5)	0	0
Nausea	54 (23)	1 (<1)	0	28 (12)	0	0
Constipation	42 (18)	1 (<1)	0	22 (9)	2 (1)	0
Stomatitis	20 (8)	2 (1)	0	19 (8)	0	1 (<1)
Diarrhea	59 (25)	11 (5)	0	11 (5)	3 (1)	1 (<1)
Vomiting	24 (10)	1 (<1)	0	8 (3)	0	0
Abdominal distension	13 (15)	0	0	4 (2)	0	0
Pneumonia	20 (8)	8 (3)	5 (2)	11 (5)	5 (2)	3 (1)
Alopecia	31 (13)	1 (<1)	1 (<1)	33 (14)	4 (2)	0
Hyperglycemia	10 (4)	1 (<1)	0	17 (7)	10 (4)	0
Decreased appetite	36 (15)	2 (1)	0	15 (6)	1 (<1)	0
Hypertension	15 (6)	1 (<1)	0	3 (1)	0	0

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, continued
The following clinically significant adverse reactions are also discussed in other sections of the labeling: • Peripheral Neuropathy [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Cardiac Toxicity [see Warnings and Precautions (5.3) ] • Pulmonary Toxicity [see Warnings and Precautions (5.4) ] • Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.5) ] • Gastrointestinal Toxicity [see Warnings and Precautions (5.6) ] • Thrombocytopenia/Neutropenia [see Warnings and Precautions (5.7) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.8) ] • Hepatic Toxicity [see Warnings and Precautions (5.9) ] • Thrombotic Microangiopathy [see Warnings and Precautions (5.10) ] Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Hospira, Inc., effective February 27, 2023 (SPL set 9fdf6169-699f-40eb-bda1-760253062b3c), via openFDA; the full label on DailyMed

What do FAERS reports show?

88,912 reports list bortezomib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,068 are coded as a death and 28,333 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 20 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

Plasma Cell Myeloma9,117
Neuropathy Peripheral6,475
Off Label Use (a use or a product term, not a reaction)6,424
Diarrhoea (named in the label)5,183
Fatigue (named in the label)4,550
Death (an outcome recorded in the report)4,196
Pneumonia (named in the label)4,069
Drug Ineffective (a use or a product term, not a reaction)3,749
Thrombocytopenia (named in the label)3,709
Nausea (named in the label)3,115
Pyrexia (named in the label)2,866
Neutropenia (named in the label)2,717
Anaemia (named in the label)2,702
Rash (named in the label)2,444
Disease Progression (a use or a product term, not a reaction)2,441
Asthenia (named in the label)2,216
Constipation (named in the label)2,201
Platelet Count Decreased2,174
Dyspnoea (named in the label)2,095
Vomiting (named in the label)1,816
Sepsis (named in the label)1,799
Intentional Product Use Issue (a use or a product term, not a reaction)1,668
Infection (named in the label)1,620
Dizziness (named in the label)1,541
Hypotension (named in the label)1,500

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Bortezomib: 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