Bortezomib Side Effects

Not all side effects for bortezomib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bortezomib: powder for solution

In addition to its needed effects, some unwanted effects may be caused by bortezomib. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking bortezomib, check with your doctor or nurse immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • confusion
  • cough
  • cough producing mucus
  • decreased urination
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • ear congestion
  • fainting
  • fever
  • headache
  • increase in heart rate
  • loss of voice
  • lower back or side pain
  • nerve pain
  • painful blisters on the trunk of the body
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid breathing
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • stuffy nose
  • sunken eyes
  • sweating
  • swollen glands
  • thirst
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • wheezing
  • wrinkled skin
Less common
  • Decreased urine output
  • dilated neck veins
  • general feeling of discomfort or illness
  • increased sensitivity to pain
  • increased sensitivity to touch
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • thickening of bronchial secretions
  • tingling in the hands and feet
  • troubled breathing
  • unsteadiness or awkwardness
  • weight gain
Incidence not known
  • Abdominal or stomach pain and tenderness
  • agitation
  • back pain
  • blistering, peeling, or loosening of the skin
  • bloating
  • bruising
  • change in consciousness
  • coma
  • coughing or vomiting blood
  • dark urine
  • deafness
  • deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
  • diarrhea
  • drowsiness
  • fast heartbeat
  • fear or nervousness
  • general tiredness and weakness
  • hallucinations
  • irritability
  • itching
  • light-colored stools
  • loss of consciousness
  • mood or mental changes
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pounding, slow heartbeat
  • rectal bleeding
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shaking
  • stiff neck
  • trouble sleeping
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some of the side effects that can occur with bortezomib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • bone pain
  • constipation
  • difficulty having a bowel movement
  • difficulty with moving
  • feeling unusually cold or shivering
  • general feeling of discomfort or illness
  • heartburn
  • indigestion
  • itching skin
  • loss of appetite
  • loss of taste
  • mental depression
  • muscle cramps
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pain in the limb
  • rash
  • sleeplessness
  • stomach discomfort or upset, or pain
  • swelling
  • swollen joints
  • unable to sleep
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to bortezomib: injectable powder for injection

General

Asthenia was predominantly reported as grade 1 or 2. Asthenia was grade 3 for 16% of patients. The first onset of fatigue was most frequently reported during the first and second cycles of therapy.

Pyrexia (greater than 38%C) was grade 3 in 3% of patients.

General side effects including asthenic conditions (fatigue, malaise, and weakness) (64%), pyrexia (34%), headache (22%), insomnia (20%), dizziness (excluding vertigo) (17%), back pain (13%), dehydration (10%), anxiety (10%), and rigors have been reported.

Gastrointestinal

Gastrointestinal side effects have been reported including nausea (55%), diarrhea (52%), constipation (42%), decreased appetite (36%), vomiting (33%), abdominal pain (15%), ascites, dyspepsia, 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, upper abdominal pain, and acute pancreatitis.

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.

Hematologic

Hematologic side effects including thrombocytopenia (36%), anemia (29%), neutropenia (17%), leukopenia, lymphopenia, disseminated intravascular coagulation, and subdural hematoma have also been reported.

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.

Nervous system

Nervous system side effects including peripheral neuropathy (39%), paresthesia and dysesthesia (22%), headache (22%), dizziness (17%), anxiety (10%), ataxia, paralysis, postherpetic neuralgia, coma, dysarthria, dysautonomia, cranial palsy, grand mal convulsion, hemorrhagic stroke, motor dysfunction, spinal cord compression, neuralgia, encephalopathy, paraplegia, cerebral hemorrhage, reversible posterior leukoencephalopathy syndrome, and transient ischemic attack have been reported. Postmarketing reports have included progressive multifocal leukoencephalopathy (PML).

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. 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.

Musculoskeletal

Musculoskeletal side effects including arthralgia (17%), pain in limb (15%), bone pain (14%), back pain (13%), myalgia (12%), muscle cramps (11%), extremity pain, and skeletal fracture have been reported.

Cardiovascular

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.

Cardiovascular side effects have been reported including edema (23%), hypotension (13%), aggravated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac arrest, congestive cardiac failure, hypertension, myocardial ischemia, myocardial infarction, pericardial effusion, pulmonary edema, cerebrovascular accident, deep vein thrombosis, peripheral embolism, pulmonary embolism, angina pectoris, bradycardia, sinus arrest, complete atrioventricular block, pericarditis, Torsades de pointes, decreased left ventricular ejection fraction, and ventricular tachycardia.

Respiratory

Respiratory side effects including dyspnea (21%), cough (20%), upper respiratory tract infection (12%), nasopharyngitis (12%), pneumonia (12%), acute respiratory distress syndrome, acute diffuse infiltrative pulmonary disease, atelectasis, bronchitis, exacerbated chronic obstructive airways disease, exertional dyspnea, epistaxis, hemoptysis, hypoxia, lower respiratory tract / lung infection, lung infiltration, pleural effusion, pulmonary hypertension, pneumonitis, respiratory distress, and respiratory failure have been reported.

Dermatologic

Dermatologic side effects including rash (18%), herpes zoster (12%), toxic epidermal necrolysis, leukocytoclastic vasculitis, pruritus, urticaria, and facial edema have been reported. One observational analysis of 47 patients treated with bortezomib in three prospective clinical trials reported five patients with sharply demarcated erythematous plaques or nodules on the trunk and one patient with generalized morbilliform erythema with ulcerations and fever. A case of cutaneous vasculitis and a case of histiocytoid Sweet syndrome have also been reported.

Other

Other side effects including dysgeusia, impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis, tumor lysis syndrome, and vertigo have been reported.

Ocular

Ocular side effects including blurred vision, conjunctival infection, irritation, and diplopia have been reported. Postmarketing reports of optic neuropathy and blindness have been received.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction, drug hypersensitivity, and immune complex mediated hypersensitivity have been reported.

Hepatic

Hepatic side effects including hyperbilirubinemia, cholestasis, hepatic hemorrhage, hepatitis, portal vein thrombosis, and asymptomatic increases in liver enzymes have been reported. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.

Metabolic

Metabolic side effects including hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia and tumor lysis syndrome have been reported.

Psychiatric

Psychiatric side effects (35%) have been reported, including anorexia (23%), agitation, confusion, psychotic disorder, mental status change, and suicidal ideation have been reported.

Renal

Renal side effects including renal calculus, bilateral hydronephrosis, bladder spasm, hematuria, urinary incontinence, urinary retention, acute and chronic renal failure, urinary tract infection, hemorrhagic cystitis, and proliferative glomerular nephritis have been reported.

Local

Local side effects including injection site erythema, catheter related infection, and catheter related complication have been reported.

Immunologic

Immunologic side effects have included angioedema and laryngeal edema.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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