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Brentuximab Side Effects

Not all side effects for brentuximab 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 brentuximab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by brentuximab. 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 brentuximab, check with your doctor or nurse immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chills
  • cough
  • difficult or labored breathing
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • lower back or side pain
  • pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • 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
Less common
  • Anxiety
  • back pain
  • bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cloudy urine
  • confusion
  • convulsions
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • fainting
  • fast heartbeat
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • irregular heartbeat
  • itching
  • joint pain, stiffness, or swelling
  • muscle pain
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe pain in the chest
  • stomach pain
  • sudden onset of severe breathing difficulty
  • sudden shortness of breath or troubled breathing
  • thickening of bronchial secretions
  • unusual weight gain or loss

Some of the side effects that can occur with brentuximab 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
  • Decreased appetite or weight
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • hair loss or thinning of the hair
  • muscle spasms
  • muscle stiffness
  • nausea
  • night sweats
  • pain in the arms or legs
  • rash
  • trouble with sleeping
  • vomiting
Less common
  • Dry skin

For Healthcare Professionals

Applies to brentuximab: intravenous powder for injection


Very common (10% or more): Rash (up to 31%), pruritus (up to 19%), alopecia (up to 14), night sweats (up to 12%), dry skin (up to 10%)
Rare (less than 0.1%): : Stevens-Johnson syndrome (SJS) (including fatal outcomes), toxic epidermal necrolysis (including fatal outcomes)[Ref]


Very common (10% or more): Nausea (up to 42%), diarrhea (up to 36%), abdominal pain (up to 25%), vomiting (up to 22%), constipation (up to 19%)
Postmarketing reports: Pancreatitis (including fatal outcomes)[Ref]


Very common (10% or more): Neutropenia (any grade) (up to 78%), anemia (up to 52%), thrombocytopenia (up to 41%), lymphadenopathy (up to 11%)
Postmarketing reports: Febrile neutropenia[Ref]


Frequency not reported: Anaphylactic reaction[Ref]


Very common (10% or more): Weight decreased (up to 19%), decreased appetite (up to 11%)
Common (1% to 10%): Hyperglycemia[Ref]


Very common (10% or more): Arthralgia (up to 19%), myalgia (up to 17%), back pain (up to 14%), pain in extremity (up to 10%)
Common (1% to 10%): Muscle spasms[Ref]

Nervous system

Very common (10% or more): Peripheral sensory neuropathy (up to 56%), peripheral motor neuropathy (up to 23%), headache (up to 19%), dizziness (up to 16%)
Common (1% to 10%): Demyelinating polyneuropathy
Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]


Other side effects have included infusion related reactions (12%) including chills, nausea, dyspnea, pruritus, pyrexia and cough.[Ref]


Very common (10% or more): Insomnia (up to 16%), anxiety (up to 11%)[Ref]


Very common (10% or more): Upper respiratory infection (up to 47%), cough (up to 25%), dyspnea (up to 17%), oropharyngeal pain (up to 11%)
Postmarketing reports: Noninfectious pulmonary toxicity (including fatal outcomes)[Ref]


Common (1% to 10%): Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Postmarketing reports: Hepatotoxicity[Ref]


Very common (10% or more): Infection
Common (1% to 10%): Sepsis/septic shock, pneumonia, herpes zoster
Uncommon (0.1% to 1%): Oral candidiasis, pneumocystis jiroveci pneumonia, staphylococcal bacteremia
Postmarketing reports: Serious opportunistic infections[Ref]


Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]


1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Adcetris (brentuximab vedotin)." Seattle Genetics Inc, Bothell, WA.

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