Does TIBOLONE Cause Malaise? 13 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 13 reports of Malaise have been filed in association with TIBOLONE. This represents 19.1% of all adverse event reports for TIBOLONE.
13
Reports of Malaise with TIBOLONE
19.1%
of all TIBOLONE reports
8
Deaths
8
Hospitalizations
How Dangerous Is Malaise From TIBOLONE?
Of the 13 reports, 8 (61.5%) resulted in death, 8 (61.5%) required hospitalization, and 8 (61.5%) were considered life-threatening.
Is Malaise Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TIBOLONE. However, 13 reports have been filed with the FAERS database.
What Other Side Effects Does TIBOLONE Cause?
Off label use (16)
Adverse drug reaction (13)
Anxiety (13)
Arthralgia (13)
Abdominal pain (12)
Alopecia (12)
Amnesia (12)
Gait disturbance (12)
Medication error (12)
Intentional product use issue (11)
What Other Drugs Cause Malaise?
ADALIMUMAB (15,965)
ETANERCEPT (13,600)
METHOTREXATE (9,970)
TOFACITINIB (9,040)
SECUKINUMAB (8,570)
INFLIXIMAB (7,477)
RITUXIMAB (6,587)
PREGABALIN (6,320)
PREDNISONE (6,319)
ABATACEPT (6,251)