Does TOLVAPTAN Cause Product use in unapproved indication? 446 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 446 reports of Product use in unapproved indication have been filed in association with TOLVAPTAN (Jynarque). This represents 5.0% of all adverse event reports for TOLVAPTAN.
446
Reports of Product use in unapproved indication with TOLVAPTAN
5.0%
of all TOLVAPTAN reports
159
Deaths
172
Hospitalizations
How Dangerous Is Product use in unapproved indication From TOLVAPTAN?
Of the 446 reports, 159 (35.7%) resulted in death, 172 (38.6%) required hospitalization, and 11 (2.5%) were considered life-threatening.
Is Product use in unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for TOLVAPTAN. However, 446 reports have been filed with the FAERS database.
What Other Side Effects Does TOLVAPTAN Cause?
Death (800)
Thirst (624)
Off label use (560)
Renal impairment (534)
Underdose (448)
Wrong technique in product usage process (426)
Polyuria (390)
Product dose omission issue (379)
Inappropriate schedule of product administration (376)
Blood creatinine increased (337)
What Other Drugs Cause Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
Which TOLVAPTAN Alternatives Have Lower Product use in unapproved indication Risk?
TOLVAPTAN vs TOPAMAX
TOLVAPTAN vs TOPIRAMATE
TOLVAPTAN vs TOPOTECAN
TOLVAPTAN vs TOPOTECAN\TOPOTECAN
TOLVAPTAN vs TOPROL