Does TISAGENLECLEUCEL Cause Pain? 44 Reports in FDA Database

Q: Does TISAGENLECLEUCEL cause Pain?

44 reports of Pain have been filed with the FDA for TISAGENLECLEUCEL, representing 1.0% of all TISAGENLECLEUCEL adverse event reports.

Q: How dangerous is Pain from TISAGENLECLEUCEL?

Of 44 reports, 15 (34.1%) resulted in death and 29 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 44 reports of Pain have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 1.0% of all adverse event reports for TISAGENLECLEUCEL.

Reports of Pain with TISAGENLECLEUCEL

1.0%

of all TISAGENLECLEUCEL reports

Deaths

Hospitalizations

How Dangerous Is Pain From TISAGENLECLEUCEL?

Of the 44 reports, 15 (34.1%) resulted in death, 29 (65.9%) required hospitalization, and 7 (15.9%) were considered life-threatening.

Is Pain Listed in the Official Label?

Yes, Pain is listed as a known adverse reaction in the official FDA drug label for TISAGENLECLEUCEL.

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)