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Lisocabtagene maraleucel Side Effects

Medically reviewed by Last updated on Jun 23, 2023.

Applies to lisocabtagene maraleucel: intravenous suspension.


Intravenous route (Suspension)

Warning: Cytokine Release Syndrome and Neurologic ToxicitiesCytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel. Do not administer lisocabtagene maraleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurological events after treatment with lisocabtagene maraleucel. Provide supportive care and/or corticosteroids as needed.Lisocabtagene maraleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi® REMS.

Serious side effects

Along with its needed effects, lisocabtagene maraleucel 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 lisocabtagene maraleucel:

More common

Other side effects

Some side effects of lisocabtagene maraleucel 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 lisocabtagene maraleucel: intravenous suspension.


Very common (10% or more): Lymphopenia (94%), neutropenia (81%), leukopenia (77%), anemia (58%), thrombocytopenia (54%), febrile neutropenia (37%), bleeding episodes (31%), international normalized ratio increased (13%)

Common (1% to 10%): Histiocytosis lymphocytic hemophagocytosis, coagulopathy, activated partial thromboplastin time prolonged[Ref]


Frequency not reported: Hypersensitivity/anaphylaxis[Ref]


Very common (10% or more): Cytokine release syndrome (79%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, immunoglobulins decreased, blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased) (43%), infections pathogen unspecified (41%), viral infections (26%), bacterial infections (19%), fungal infections (13%)

Common (1% to 10%): Graft versus host disease

Frequency not reported: Immunogenicity[Ref]


Very common (10% or more): Myalgia (15%), arthralgia (12%), back pain/pain in extremity (10%)

Common (1% to 10%): Muscle spasms[Ref]


Very common (10% or more): Decreased appetite (37%), hypophosphatemia (24%), edema (e.g., face edema, generalized edema, localized edema, edema peripheral) (21%), hypokalemia (12%), hyponatremia (11%), weight loss (11%), fluid overload (10%)

Common (1% to 10%): Tumor lysis syndrome[Ref]


Very common (10% or more): Delirium (21%), anxiety (13%), sleep disorders/insomnia/nightmare (10%)[Ref]


Very common (10% or more): Acute kidney injury (e.g., acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, blood creatinine increased) (24%), increased alanine aminotransferase (21%), increased bilirubin (21%)


Frequency not reported: Secondary malignancies/cancer recurrence[Ref]


Very common (10% or more): Hypoxia (24%), cough/productive cough (21%), dyspnea/respiratory distress/respiratory failure (16%), pulmonary edema (16%), tachypnea (12%), pleural effusion (10%), nasal congestion (10%)

Common (1% to 10%): Respiratory distress, respiratory failure, acute respiratory distress syndrome, oropharyngeal pain[Ref]


Very common (10% or more): Fatigue/malaise (48%), pyrexia (40%), increased aspartate aminotransferase (28%), hypokalemia (27%), hypophosphatemia pain (18%), fever (16%), chills (12%)

Common (1% to 10%): Multiple organ dysfunction syndrome[Ref]


Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (2% or greater) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.[Ref]

Nervous system

Very common (10% or more): Headache/migraine (30%), encephalopathy (e.g., encephalopathy, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, lethargy, mental status changes, somnolence, automatism) (29%), delirium (e.g., delirium, agitation, hallucination, hallucination visual, irritability, restlessness) (21%), peripheral neuropathy (11%)

Common (1% to 10%): Tremor, dizziness, seizure, speech disorder/aphasia/dysarthria, motor dysfunction[Ref]


Very common (10% or more): Acute kidney injury (24%)[Ref]


Very common (10% or more): Hypotension (26%), tachycardia/sinus tachycardia (25%)

Common (1% to 10%): Disseminated intravascular coagulation, cardiac arrest, cardiac failure, capillary leak syndrome, thrombosis[Ref]


Very common (10% or more): Rash/rash maculopapular/rash papular/rash pruritic (16%)[Ref]


Very common (10% or more): Nausea (33%), diarrhea (26%), constipation (23%), vomiting (21%), abdominal pain (21%)[Ref]


Common (1% to 10%): Visual impairment[Ref]


1. Product Information. Breyanzi (lisocabtagene maraleucel). Bristol-Myers Squibb. 2021.

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.