Does DANAZOL Cause Off label use? 51 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 51 reports of Off label use have been filed in association with DANAZOL (Danazol). This represents 10.7% of all adverse event reports for DANAZOL.
51
Reports of Off label use with DANAZOL
10.7%
of all DANAZOL reports
6
Deaths
19
Hospitalizations
How Dangerous Is Off label use From DANAZOL?
Of the 51 reports, 6 (11.8%) resulted in death, 19 (37.3%) required hospitalization, and 4 (7.8%) 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 DANAZOL. However, 51 reports have been filed with the FAERS database.
What Other Side Effects Does DANAZOL Cause?
Drug ineffective (155)
Hepatic enzyme increased (95)
Nausea (94)
Neutropenia (88)
Constipation (87)
Coombs positive haemolytic anaemia (87)
Haemolysis (87)
Infusion related reaction (87)
Lymphadenitis (87)
Migraine (86)
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 DANAZOL Alternatives Have Lower Off label use Risk?
DANAZOL vs DANICOPAN
DANAZOL vs DANTROLENE
DANAZOL vs DAPAGLIFLOZIN
DANAZOL vs DAPAGLIFLOZIN PROPANEDIOL
DANAZOL vs DAPAGLIFLOZIN PROPANEDIOL\METFORMIN