Does TIBOLONE Cause Stomatitis? 8 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 8 reports of Stomatitis have been filed in association with TIBOLONE. This represents 11.8% of all adverse event reports for TIBOLONE.
8
Reports of Stomatitis with TIBOLONE
11.8%
of all TIBOLONE reports
8
Deaths
8
Hospitalizations
How Dangerous Is Stomatitis From TIBOLONE?
Of the 8 reports, 8 (100.0%) resulted in death, 8 (100.0%) required hospitalization, and 8 (100.0%) were considered life-threatening.
Is Stomatitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TIBOLONE. However, 8 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)
Malaise (13)
Abdominal pain (12)
Alopecia (12)
Amnesia (12)
Gait disturbance (12)
Medication error (12)
What Other Drugs Cause Stomatitis?
METHOTREXATE (7,245)
TOCILIZUMAB (4,761)
ADALIMUMAB (4,500)
LEFLUNOMIDE (4,492)
ABATACEPT (4,481)
ETANERCEPT (4,338)
RITUXIMAB (4,335)
CERTOLIZUMAB PEGOL (3,760)
INFLIXIMAB (3,713)
PREDNISONE (3,656)