Does PITOLISANT Cause Off label use? 27 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 27 reports of Off label use have been filed in association with PITOLISANT (Wakix). This represents 3.2% of all adverse event reports for PITOLISANT.
27
Reports of Off label use with PITOLISANT
3.2%
of all PITOLISANT reports
1
Deaths
4
Hospitalizations
How Dangerous Is Off label use From PITOLISANT?
Of the 27 reports, 1 (3.7%) resulted in death, 4 (14.8%) required hospitalization, and 2 (7.4%) 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 PITOLISANT. However, 27 reports have been filed with the FAERS database.
What Other Side Effects Does PITOLISANT Cause?
Drug ineffective (128)
Headache (122)
Insomnia (112)
Nausea (98)
Anxiety (92)
Fatigue (75)
Somnolence (59)
Product dose omission issue (53)
Depression (47)
Dizziness (43)
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 PITOLISANT Alternatives Have Lower Off label use Risk?
PITOLISANT vs PIXANTRONE
PITOLISANT vs PIZOTYLINE
PITOLISANT vs PLACEBO
PITOLISANT vs PLAN B ONE-STEP
PITOLISANT vs PLANTAGO LANCEOLATA POLLEN