Does VEDOLIZUMAB Cause Insomnia? 739 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Insomnia?

739 reports of Insomnia have been filed with the FDA for VEDOLIZUMAB, representing 1.0% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Insomnia from VEDOLIZUMAB?

Of 739 reports, 150 (20.3%) resulted in death and 340 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 739 reports of Insomnia have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 1.0% of all adverse event reports for VEDOLIZUMAB.

739

Reports of Insomnia with VEDOLIZUMAB

1.0%

of all VEDOLIZUMAB reports

150

Deaths

340

Hospitalizations

How Dangerous Is Insomnia From VEDOLIZUMAB?

Of the 739 reports, 150 (20.3%) resulted in death, 340 (46.0%) required hospitalization, and 142 (19.2%) were considered life-threatening.

Is Insomnia Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for VEDOLIZUMAB. However, 739 reports have been filed with the FAERS database.

What Other Side Effects Does VEDOLIZUMAB Cause?

Off label use (21,017) Colitis ulcerative (13,455) Crohn's disease (9,759) Drug ineffective (8,424) Diarrhoea (7,493) Abdominal pain (6,401) Fatigue (5,477) Haematochezia (5,215) Frequent bowel movements (4,527) Arthralgia (4,028)

What Other Drugs Cause Insomnia?

ADALIMUMAB (6,888) DULOXETINE (5,270) ETANERCEPT (4,983) PREGABALIN (4,882) METHOTREXATE (4,757) LEVOTHYROXINE (4,663) TOCILIZUMAB (4,001) PREDNISONE (3,804) LENALIDOMIDE (3,651) RITUXIMAB (3,637)

Which VEDOLIZUMAB Alternatives Have Lower Insomnia Risk?

VEDOLIZUMAB vs VELAGLUCERASE ALFA VEDOLIZUMAB vs VELCADE VEDOLIZUMAB vs VELETRI VEDOLIZUMAB vs VELIPARIB VEDOLIZUMAB vs VEMURAFENIB

VEDOLIZUMAB Full Profile All Insomnia Reports All Drugs Causing Insomnia VEDOLIZUMAB Demographics