Does TISAGENLECLEUCEL Cause Fall? 14 Reports in FDA Database

Q: Does TISAGENLECLEUCEL cause Fall?

14 reports of Fall have been filed with the FDA for TISAGENLECLEUCEL, representing 0.3% of all TISAGENLECLEUCEL adverse event reports.

Q: How dangerous is Fall from TISAGENLECLEUCEL?

Of 14 reports, 2 (14.3%) resulted in death and 8 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 14 reports of Fall have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 0.3% of all adverse event reports for TISAGENLECLEUCEL.

Reports of Fall with TISAGENLECLEUCEL

0.3%

of all TISAGENLECLEUCEL reports

Deaths

Hospitalizations

How Dangerous Is Fall From TISAGENLECLEUCEL?

Of the 14 reports, 2 (14.3%) resulted in death, 8 (57.1%) required hospitalization, and 2 (14.3%) were considered life-threatening.

Is Fall Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for TISAGENLECLEUCEL. However, 14 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)