Does ROFLUMILAST Cause Insomnia? 151 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 151 reports of Insomnia have been filed in association with ROFLUMILAST (ROFLUMILAST). This represents 5.6% of all adverse event reports for ROFLUMILAST.
151
Reports of Insomnia with ROFLUMILAST
5.6%
of all ROFLUMILAST reports
2
Deaths
29
Hospitalizations
How Dangerous Is Insomnia From ROFLUMILAST?
Of the 151 reports, 2 (1.3%) resulted in death, 29 (19.2%) required hospitalization, and 6 (4.0%) were considered life-threatening.
Is Insomnia Listed in the Official Label?
Yes, Insomnia is listed as a known adverse reaction in the official FDA drug label for ROFLUMILAST.
What Other Side Effects Does ROFLUMILAST Cause?
Death (569)
Dyspnoea (433)
Chronic obstructive pulmonary disease (292)
Diarrhoea (265)
Off label use (242)
Weight decreased (224)
Nausea (191)
Pneumonia (176)
Headache (166)
Malaise (164)
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 ROFLUMILAST Alternatives Have Lower Insomnia Risk?
ROFLUMILAST vs ROLAPITANT
ROFLUMILAST vs ROMIDEPSIN
ROFLUMILAST vs ROMIPLOSTIM
ROFLUMILAST vs ROMOSOZUMAB
ROFLUMILAST vs ROMOSOZUMAB-AQQG