Mesalamine Formulation Switch Linked to Acute Renal Failure in UC Patient

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The 35-year-old male from Hawaii maintained clinical remission with Lialda, a once-daily formulation of mesalamine, and infliximab.

A switch in the oral formulation of mesalamine led to acute renal failure in a patient with moderate pan-ulcerative colitis, according to a case report presented by experts from the University of Texas Health Science Center at San Antonio, San Antonio, TX. 

The 35-year-old male from Hawaii maintained clinical remission with Lialda, a once-daily formulation of mesalamine, and infliximab. After his care was transitioned from Hawaii to Texas, he developed acute renal failure with an increase in creatinine levels from baseline 1.2mg/dL to 2mg/dL as well as positive urine eosinophils. This occurred 2 weeks after his medication was changed from Lialda to Apriso, a once-daily, delayed and extended-release formulation of mesalamine.

One week after discontinuing Apriso, the patient’s creatinine normalized to 1.3mg/dL and a renal ultrasound showed unremarkable findings. The patient was not rechallenged with Lialda as advised by the nephrology team. 

Mesalamine has generally been established as a safe first-line treatment for ulcerative colitis. As systemic exposure of mesalamine has been shown to be similar across all oral formulations and prodrugs, it can be inferred that the side effect profile should therefore also be equivalent. 

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However, in this case, the authors speculate the patient’s nephrotoxicity may have been “secondary to variable drug metabolism and exposure to a higher dose of active metabolites.”  They conclude by stating that clinicians should use caution when considering an oral mesalamine formulation switch.


Malakouti, M; Patel, C; Lunsford, T. MESALAMINE-INDUCED NEPHROTOXICITY CAUSED BY SWITCH IN ORAL FORMULATION OF MESALAMINE IN A PATIENT WITH ULCERATIVE COLITIS: CASE REPORT AND REVIEW OF LITERATURE. Program No. P1325. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.