Does TISAGENLECLEUCEL Cause Colitis? 13 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 13 reports of Colitis have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 0.3% of all adverse event reports for TISAGENLECLEUCEL.
13
Reports of Colitis with TISAGENLECLEUCEL
0.3%
of all TISAGENLECLEUCEL reports
5
Deaths
10
Hospitalizations
How Dangerous Is Colitis From TISAGENLECLEUCEL?
Of the 13 reports, 5 (38.5%) resulted in death, 10 (76.9%) required hospitalization, and 5 (38.5%) were considered life-threatening.
Is Colitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TISAGENLECLEUCEL. However, 13 reports have been filed with the FAERS database.
What Other Side Effects Does TISAGENLECLEUCEL Cause?
Cytokine release syndrome (1,660)
Pyrexia (1,030)
Malignant neoplasm progression (582)
Hypotension (425)
Immune effector cell-associated neurotoxicity syndrome (416)
Neurotoxicity (411)
Platelet count decreased (397)
White blood cell count decreased (392)
Hypogammaglobulinaemia (374)
Lymphocyte count decreased (365)
What Other Drugs Cause Colitis?
ADALIMUMAB (3,043)
NIVOLUMAB (2,123)
IPILIMUMAB (1,988)
PEMBROLIZUMAB (1,638)
INFLIXIMAB (1,254)
METHOTREXATE (1,166)
PREDNISONE (1,100)
VEDOLIZUMAB (1,077)
CARBOPLATIN (993)
MESALAMINE (839)
Which TISAGENLECLEUCEL Alternatives Have Lower Colitis Risk?
TISAGENLECLEUCEL vs TISLELIZUMAB
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN
TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN-TFTV
TISAGENLECLEUCEL vs TITANIUM DIOXIDE\ZINC
TISAGENLECLEUCEL vs TIVICAY