Bendamustine Side Effects

Some side effects of bendamustine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bendamustine: intravenous powder for solution, intravenous solution

Along with its needed effects, bendamustine 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 bendamustine:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough or hoarseness
  • diarrhea
  • fever
  • headache
  • joint pain, stiffness, or swelling
  • lack or loss of strength
  • lower back, side, or stomach pain
  • muscle aches
  • nausea
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • stuffy or runny nose
  • swelling of the feet or lower legs
  • swollen glands
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
Less common
  • Burning or stinging of the skin
  • fast heartbeat
  • hives
  • itching
  • irritation
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • rash
  • redness of the skin
  • stiffness or swelling
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
Incidence not known
  • Blistering, flaking, or peeling of the skin
  • bluish color
  • changes in skin color
  • dizziness
  • pain, tenderness, or swelling of the foot or leg
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • weakness

Some side effects of bendamustine 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
  • Decreased weight

For Healthcare Professionals

Applies to bendamustine: intravenous powder for injection

Hematologic

Hematologic side effects including neutropenia (28%), thrombocytopenia (23%), anemia (19%), leukopenia (18%), lymphopenia (7%), and tumor lysis syndrome have been reported.

Laboratory abnormalities have included decreased lymphocytes (up to 99%), decreased leukocytes (up to 94%). decreased hemoglobin (up to 89%), decreased platelets (up to 86%), and decreased neutrophils (up to 86%).

Tumor lysis syndrome associated with bendamustine treatment has been reported in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of bendamustine and, without intervention, may lead to acute renal failure and death. Preventive measures include maintaining adequate volume status, and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of bendamustine therapy. However, there may be an increased risk of severe skin toxicity when bendamustine and allopurinol are administered concomitantly.

Red blood cell transfusions were administered to 20% of patients receiving bendamustine.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 75%), vomiting (up to 40%), diarrhea (up to 37%) constipation (29%), stomatitis (15%), abdominal pain (13%), dyspepsia (11%), gastroesophageal reflux disease (10%), dry mouth (9%), upper abdominal pain (5%), and abdominal distension (5%) have been reported.

General

General side effects including fatigue (up to 57%), pyrexia (up to 34%), chills (up to 14%), peripheral edema (13%), asthenia (up to 11%), and chest pain (6%) have been reported.

Metabolic

Metabolic side effects including anorexia (23%), dehydration (14%), decreased appetite (13%), hypokalemia (9%), and hyperuricemia (7%) have been reported.

Respiratory

Respiratory side effects including cough (up to 22%), dyspnea (16%), upper respiratory tract infection (10%), sinusitis (9%), pneumonia (8%), pharyngolaryngeal pain (8%), nasopharyngitis (7%), wheezing (5%), nasal congestion (5%), and cough (4%) have been reported.

Nervous system

Nervous system side effects including headache (21%), dizziness (14%), and dysgeusia (7%) have been reported.

Dermatologic

Dermatologic side effects including rash (up to 16%) pruritus (up to 6%), dry skin (5%), night sweats (5%), hyperhidrosis (5%), toxic skin reactions, and bullous exanthema have been reported. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) some fatal, have also been reported.

Some skin reactions have occurred when bendamustine was given in combination with other anticancer agents, so the precise relationship to bendamustine is uncertain.

Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, bendamustine should be withheld or discontinued.

Musculoskeletal

Musculoskeletal side effects including back pain (14%), arthralgia (6%), pain in extremity (5%), and bone pain (5%) have been reported.

Psychiatric

Psychiatric side effects including insomnia (13%), anxiety (8%), and depression (6%) have been reported.

Other

Other side effects including herpes zoster (10%), decreased weight (7%), febrile neutropenia (6%), oral candidiasis (6%), infection (6%), and herpes simplex (3%) have been reported.

Renal

Renal side effects including urinary tract infection (10%) have been reported.

Cardiovascular

Cardiovascular side effects including tachycardia (7%) and hypotension (6%) have been reported.

Local

There have been postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling, and pain. Precautions should be taken to avoid extravasation, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and necrosis both during and after administration.

Local side effects including infusion site pain (6%), catheter site pain (5%), extravasations, phlebitis, pruritus, irritation, pain, and swelling have been reported.

Immunologic

Immunologic side effects including hypersensitivity (5%) have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

Oncologic

Oncologic side effects have included pre-malignant and malignant diseases that have been reported in patients who have been treated with bendamustine, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma.

The association between the oncologic side effects and bendamustine therapy has not been determined.

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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