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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does TISAGENLECLEUCEL Cause Somnolence? 67 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 67 reports of Somnolence have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 1.6% of all adverse event reports for TISAGENLECLEUCEL.

67
Reports of Somnolence with TISAGENLECLEUCEL
1.6%
of all TISAGENLECLEUCEL reports
29
Deaths
39
Hospitalizations

How Dangerous Is Somnolence From TISAGENLECLEUCEL?

Of the 67 reports, 29 (43.3%) resulted in death, 39 (58.2%) required hospitalization, and 23 (34.3%) were considered life-threatening.

Is Somnolence Listed in the Official Label?

Yes, Somnolence 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) Platelet count decreased (397) White blood cell count decreased (392) Hypogammaglobulinaemia (374) Lymphocyte count decreased (365)

What Other Drugs Cause Somnolence?

PREGABALIN (5,528) QUETIAPINE (4,394) ACETAMINOPHEN (3,923) GABAPENTIN (3,798) SODIUM OXYBATE (3,642) CETIRIZINE (3,058) OLANZAPINE (2,612) DIAZEPAM (2,547) RISPERIDONE (2,496) OXYCODONE (2,494)

Which TISAGENLECLEUCEL Alternatives Have Lower Somnolence Risk?

TISAGENLECLEUCEL vs TISLELIZUMAB TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN TISAGENLECLEUCEL vs TISOTUMAB VEDOTIN-TFTV TISAGENLECLEUCEL vs TITANIUM DIOXIDE\ZINC TISAGENLECLEUCEL vs TIVICAY

Related Pages

TISAGENLECLEUCEL Full Profile All Somnolence Reports All Drugs Causing Somnolence TISAGENLECLEUCEL Demographics