Does GEFITINIB Cause Somnolence? 16 Reports in FDA Database

Q: Does GEFITINIB cause Somnolence?

16 reports of Somnolence have been filed with the FDA for GEFITINIB, representing 0.3% of all GEFITINIB adverse event reports.

Q: How dangerous is Somnolence from GEFITINIB?

Of 16 reports, 3 (18.8%) resulted in death and 5 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 16 reports of Somnolence have been filed in association with GEFITINIB (Gefitinib). This represents 0.3% of all adverse event reports for GEFITINIB.

Reports of Somnolence with GEFITINIB

0.3%

of all GEFITINIB reports

Deaths

Hospitalizations

How Dangerous Is Somnolence From GEFITINIB?

Of the 16 reports, 3 (18.8%) resulted in death, 5 (31.3%) required hospitalization.

Is Somnolence Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for GEFITINIB. However, 16 reports have been filed with the FAERS database.

What Other Side Effects Does GEFITINIB Cause?

Malignant neoplasm progression (1,651) Drug resistance (1,228) Death (590) Diarrhoea (393) Rash (318) Metastases to central nervous system (306) Acquired gene mutation (250) Disease progression (244) <