Does SIROLIMUS Cause Colitis? 43 Reports in FDA Database

Q: Does SIROLIMUS cause Colitis?

43 reports of Colitis have been filed with the FDA for SIROLIMUS, representing 0.4% of all SIROLIMUS adverse event reports.

Q: How dangerous is Colitis from SIROLIMUS?

Of 43 reports, 4 (9.3%) resulted in death and 19 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 43 reports of Colitis have been filed in association with SIROLIMUS (sirolimus). This represents 0.4% of all adverse event reports for SIROLIMUS.

Reports of Colitis with SIROLIMUS

0.4%

of all SIROLIMUS reports

Deaths

Hospitalizations

How Dangerous Is Colitis From SIROLIMUS?

Of the 43 reports, 4 (9.3%) resulted in death, 19 (44.2%) required hospitalization, and 6 (14.0%) were considered life-threatening.

Is Colitis Listed in the Official Label?

Yes, Colitis is listed as a known adverse reaction in the official FDA drug label for SIROLIMUS.

What Other Side Effects Does SIROLIMUS Cause?

Off label use (1,960) Drug ineffective (1,005) Product use in unapproved indication (984) Transplant rejection (698) Pneumonia (599) Product use issue (506) Alopecia (491) Acne (482) Transplant dysfunction (468) Condition aggravated (433)

What Other Drugs Cause Colitis?

ADALIMUMAB (3,043) NIVOLUMAB (2,123) IPILIMUMAB (1,988) PEMBROLIZUMAB (1,638) INFLIXIMAB (1,254) METHOTREXATE (1,166) PREDNISONE (1,100) VEDOLIZUMAB (1,077) CARBOPLATIN (993) MESALAMINE (839)

Which SIROLIMUS Alternatives Have Lower Colitis Risk?

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

SIROLIMUS Full Profile All Colitis Reports All Drugs Causing Colitis SIROLIMUS Demographics