Does ROFLUMILAST Cause Off label use? 242 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 242 reports of Off label use have been filed in association with ROFLUMILAST (ROFLUMILAST). This represents 9.0% of all adverse event reports for ROFLUMILAST.
242
Reports of Off label use with ROFLUMILAST
9.0%
of all ROFLUMILAST reports
7
Deaths
65
Hospitalizations
How Dangerous Is Off label use From ROFLUMILAST?
Of the 242 reports, 7 (2.9%) resulted in death, 65 (26.9%) required hospitalization, and 8 (3.3%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for ROFLUMILAST. However, 242 reports have been filed with the FAERS database.
What Other Side Effects Does ROFLUMILAST Cause?
Death (569)
Dyspnoea (433)
Chronic obstructive pulmonary disease (292)
Diarrhoea (265)
Weight decreased (224)
Nausea (191)
Pneumonia (176)
Headache (166)
Malaise (164)
Asthma (158)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which ROFLUMILAST Alternatives Have Lower Off label use Risk?
ROFLUMILAST vs ROLAPITANT
ROFLUMILAST vs ROMIDEPSIN
ROFLUMILAST vs ROMIPLOSTIM
ROFLUMILAST vs ROMOSOZUMAB
ROFLUMILAST vs ROMOSOZUMAB-AQQG