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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does MYCOPHENOLATE MOFETIL Cause Product use in unapproved indication? 5,910 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 5,910 reports of Product use in unapproved indication have been filed in association with MYCOPHENOLATE MOFETIL (Mycophenolate mofetil). This represents 7.9% of all adverse event reports for MYCOPHENOLATE MOFETIL.

5,910
Reports of Product use in unapproved indication with MYCOPHENOLATE MOFETIL
7.9%
of all MYCOPHENOLATE MOFETIL reports
1,185
Deaths
1,425
Hospitalizations

How Dangerous Is Product use in unapproved indication From MYCOPHENOLATE MOFETIL?

Of the 5,910 reports, 1,185 (20.1%) resulted in death, 1,425 (24.1%) required hospitalization, and 701 (11.9%) 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 MYCOPHENOLATE MOFETIL. However, 5,910 reports have been filed with the FAERS database.

What Other Side Effects Does MYCOPHENOLATE MOFETIL Cause?

Off label use (13,474) Drug ineffective (7,729) Diarrhoea (3,628) Cytomegalovirus infection (3,278) Pneumonia (3,017)