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Velcade Side Effects

Generic name: bortezomib

Medically reviewed by Last updated on Dec 11, 2023.

Note: This document contains side effect information about bortezomib. Some dosage forms listed on this page may not apply to the brand name Velcade.

Applies to bortezomib: powder for solution, solution.

Serious side effects of Velcade

Along with its needed effects, bortezomib (the active ingredient contained in Velcade) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking bortezomib:

More common

Less common

Incidence not known

Other side effects of Velcade

Some side effects of bortezomib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to bortezomib: injectable powder for injection, intravenous injection, intravenous powder for injection, intravenous solution.


Very common (10% or more): Nausea (up to 64%), diarrhea (up to 51%), constipation (up to 43%), decreased appetite (up to 43%), vomiting (up to 36%), dyspepsia (up to 13%)

Frequency not reported: Ascites, dysphagia, fecal impaction, hemorrhagic gastritis, gastrointestinal hemorrhage, hematemesis, paralytic ileus, large intestinal obstruction, paralytic intestinal obstruction, small intestinal obstruction, large intestinal perforation, stomatitis, melena, gastroenteritis, hemorrhagic duodenitis, peritonitis, oral mucosal petechiae, gastroesophageal reflux, acute pancreatitis[Ref]

Grade 3 gastrointestinal events were reported to have occurred in 18% of patients and Grade 4 events were reported in 1%. Gastrointestinal events were considered to be serious in 11% of patients.[Ref]


Very common (10% or more): Thrombocytopenia (34%), neutropenia (27%), anemia (23%), leukopenia (20%), lymphopenia (23%)

Uncommon (0.1% to 1%): Lymphadenopathy, febrile neutropenia, pancytopenia, hemolytic anemia, thrombocytopenia purpura

Frequency not reported: Disseminated intravascular coagulation, subdural hematoma, pancytopenia, hemolytic anemia, thrombocytopenia purpura[Ref]

Thrombocytopenia was characterized by a dose related decrease in platelet count during the dosing period (days 1 through 11) with a return to the baseline platelet count during the rest period (days 12 through 21) of each treatment cycle. Thrombocytopenia was grade 3 or 4 for 24% and 5% of patients, respectively.

Grade 3 or 4 neutropenia have been reported to have occurred in 9% and 3% of treated patients, respectively.[Ref]

Nervous system

Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with preexisting symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy during treatment with bortezomib (the active ingredient contained in Velcade) Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require change in the dose and schedule of bortezomib.

Following dose adjustments, improvement in or resolution of peripheral neuropathy has been reported in 51% of patients with peripheral neuropathy greater than or equal to grade 2 in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy has been reported in 73% of patients who discontinued due to grade 2 neuropathy or who had greater than or equal to grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.[Ref]

Very common (10% or more): Peripheral neuropathy (39%), paresthesia and dysesthesia (23%), headache (22%), dizziness (17%), dysgeusia (13%), anxiety (10%)

Common (1% to 10%): Peripheral sensory neuropathy, tremor

Uncommon (0.1% to 1%): Cerebrovascular accident, convulsion, syncope, disturbance in attention, increased activity, ageusia, somnolence, migraine, jerky movements, postural dizziness, sciatica, post herpetic neuralgia, cognitive disorder, mononeuropathy, paresis, restless leg syndrome, speech disorder, intracranial hemorrhage, paraplegia, subarachnoid hemorrhage

Postmarketing reports: Autonomic neuropathy, encephalopathy[Ref]


Very common (10% or more): Arthralgia (26%), pain in limb (26%), bone pain (14%), myalgia (14%), muscle cramps (14%), back pain (13%)

Common (1% to 10%): Peripheral swelling, muscle weakness, musculoskeletal pain

Uncommon (0.1% to 1%): Joint stiffness, buttock pain, joint swelling, muscle spasms, muscle twitching, sensation of heaviness, muscle stiffness, swelling, pain in jaw[Ref]


Very common (10% or more): Hypotension (13%)

Frequency not reported: Aggravated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac arrest, congestive cardiac failure, hypertension, myocardial ischemia, myocardial infarction, pericardial effusion, pulmonary edema, angina pectoris, bradycardia, sinus arrest, complete atrioventricular block, pericarditis, Torsades de pointes, decreased left ventricular ejection fraction, ventricular tachycardia[Ref]

Most reports of hypotension (including orthostatic hypotension) were grade 1 or 2 in severity. Grade 3 hypotension was reported to have occurred in 3% and Grade 4 hypotension was reported in less than 1% of patients.[Ref]


Very common (10% or more): Dyspnea (22%), cough (20%), upper respiratory tract infection (18%), cough (17%), lower respiratory tract/lung infection (15%), nasopharyngitis (14%), pneumonia (12%)

Common (1% to 10%): Epistaxis, dyspnea on exertion, rhinorrhea, bronchitis, sinusitis

Uncommon (0.1% to 1%): Nasal congestion, wheezing, pleural effusion, hoarseness, chest wall pain, hypoxia, pulmonary congestion, rhinitis, asthma, hyperventilation, orthopnea, sinus pain, throat tightness, productive cough, respiratory alkalosis, respiratory arrest, tachypnea, pneumococcal, bronchopneumonia, pleural infection, pulmonary edema

Frequency not reported: Acute respiratory distress syndrome, acute diffuse infiltrative pulmonary disease, atelectasis, exacerbated chronic obstructive airways disease, hemoptysis, pulmonary hypertension, pulmonary alveolar hemorrhage[Ref]


Very common (10% or more): Rash (18%), herpes zoster (12%)

Very rare (less than 0.01%): Erythematous plaques or nodules on the trunk, generalized morbilliform erythema with ulcerations and fever, cutaneous vasculitis, histiocytoid Sweet Syndrome

Frequency not reported: Toxic epidermal necrolysis, leukocytoclastic vasculitis, pruritus, urticaria, facial edema[Ref]


Very common (10% or more): Asthenic conditions (fatigue, malaise, and weakness) (65%), pyrexia (36%), headache (28%), insomnia (27%), dizziness (excluding vertigo) (21%), dehydration (18%), anxiety (14%), fatigue (15%), dysgeusia (13%), rigors (12%)

Common (1% to 10%): Pyrexia

Frequency not reported: Impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis, tumor lysis syndrome, vertigo[Ref]


Very common (10% or more): Blurred vision (11%)

Common (1% to 10%): Eye pain

Uncommon (0.1% to 1%): Dry eye, conjunctivitis, eye discharge, abnormal vision, eye hemorrhage, photophobia, eye irritation, increased lacrimation, conjunctival hyperemia, blepharitis, eye swelling

Rare (less than 0.1%): Ophthalmic herpes

Frequency not reported: Conjunctival infection, irritation, diplopia

Postmarketing reports: Optic neuropathy, blindness[Ref]


Very rare (less than 0.01%): Stevens-Johnson Syndrome

Frequency not reported: Anaphylactic reaction, drug hypersensitivity, immune complex mediated hypersensitivity[Ref]


Rare (less than 0.1%): Acute liver failure (in patients receiving multiple concomitant medications and with serious underlying medical conditions)

Frequency not reported: Hyperbilirubinemia, cholestasis, hepatic hemorrhage, hepatitis, portal vein thrombosis, asymptomatic increases in liver enzymes[Ref]


Very common (10% or more): Anorexia (34 to 43%), dehydration (18%)

Common (1% to 10%): Hyper- or hypocalcemia, hypokalemia, decreased weight, increased blood lactate dehydrogenase

Uncommon (0.1% to 1%): Hypoglycemia, hyperkalemia, hyperuricemia, hyper or hyponatremia, hypomagnesemia, hypophosphatemia, decreased blood bicarbonate levels, increased blood alkaline phosphatase, urea, blood amylase, and C-reactive protein, increased appetite and weight, cachexia, vitamin B12 deficiency, tumor lysis syndrome[Ref]


Very common (10% or more): Peripheral neuropathies (50%), insomnia (18 to 27%), neuralgia (23%), anxiety (14%)

Common (1% to 10%): Agitation, confusion, depression

Uncommon (0.1% to 1%): Delirium, restlessness, mood swings, mental status changes, sleep disorder, irritability, hallucinations, abnormal dreams

Frequency not reported: Agitation, confusion, psychotic disorder, mental status change, suicidal ideation[Ref]


Very common (10% or more): Acute and chronic renal impairment, dysuria

Uncommon (0.1% to 1%): Increased blood creatinine

Frequency not reported: Renal calculus, renal colic, hematuria, proteinuria, difficulty in micturition or micturition urgency, oliguria, bilateral hydronephrosis, bladder spasm, urinary tract infection, hemorrhagic cystitis, proliferative glomerular nephritis[Ref]


Uncommon (0.1% to 1%): Injection site erythema, catheter related infection, catheter related complication, post procedural pain, post procedural hemorrhage, burns[Ref]


Frequency not reported: Angioedema, laryngeal edema[Ref]


Uncommon (0.1% to 1%): Syndrome of Inappropriate Antidiuretic Hormone (SIADH)


Uncommon (0.1% to 1%): Testicular pain, erectile dysfunction

Frequently asked questions


1. (2003) "Product Information. Velcade (bortezomib)." Millennium Pharmaceuticals Inc

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

4. Garcia-Navarro X, Puig L, Fernandez-Figueras MT, Dalmau J, Roe E, Alomar A (2007) "Bortezomib-associated cutaneous vasculitis." Br J Dermatol

5. Murase JE, Wu JJ, Theate I, Cole GW, Barr RJ, Dyson SW (2009) "Bortezomib-induced histiocytoid Sweet syndrome." J Am Acad Dermatol, 60, p. 496-7

6. Kenealy MK, Prince HM, Honemann D, Jaskiewicz AD, Herrington JD (2006) "Tumor lysis syndrome early after treatment with bortezomib for multiple myeloma." Pharmacotherapy, 26, p. 1205-6

7. Rosinol L, Montoto S, Cibeira MT, Blade J (2005) "Bortezomib-induced severe hepatitis in multiple myeloma: a case report." Arch Intern Med, 165, p. 464-5

8. Terpos E, Politou M, Rahemtulla A (2004) "Tumour lysis syndrome in multiple myeloma after bortezomib (VELCADE) administration." J Cancer Res Clin Oncol

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.