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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 SIROLIMUS Cause Product use in unapproved indication? 984 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 984 reports of Product use in unapproved indication have been filed in association with SIROLIMUS (sirolimus). This represents 8.7% of all adverse event reports for SIROLIMUS.

984
Reports of Product use in unapproved indication with SIROLIMUS
8.7%
of all SIROLIMUS reports
171
Deaths
268
Hospitalizations

How Dangerous Is Product use in unapproved indication From SIROLIMUS?

Of the 984 reports, 171 (17.4%) resulted in death, 268 (27.2%) required hospitalization, and 58 (5.9%) 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 SIROLIMUS. However, 984 reports have been filed with the FAERS database.

What Other Side Effects Does SIROLIMUS Cause?

Off label use (1,960) Drug ineffective (1,005) Transplant rejection (698) Pneumonia (599) Product use issue (506) Alopecia (491) Acne (482) Transplant dysfunction (468) Condition aggravated (433) Ovarian cyst (420)

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 SIROLIMUS Alternatives Have Lower Product use in unapproved indication Risk?

SIROLIMUS vs SIRUKUMAB SIROLIMUS vs SITAGLIPTIN SIROLIMUS vs SOAP SIROLIMUS vs SODIUM SIROLIMUS vs SODIUM BICARBONATE

Related Pages

SIROLIMUS Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication SIROLIMUS Demographics