Rezulin Side Effects
Generic Name: troglitazone
Note: This document contains side effect information about troglitazone. Some of the dosage forms listed on this page may not apply to the brand name Rezulin.
Applies to troglitazone: oral tablet
During clinical trials, 1.9% of patients experienced reversible elevations in alanine transaminase (ALT) greater than 3 times the upper normal limit. Approximately 5% of patients had ALT levels greater than 1.5 times the upper limit of normal. Hyperbilirubinemia was found in 0.7% of patients (however, this incidence was less than that of patients receiving placebo).[Ref]
Hepatic side effects including severe idiosyncratic hepatocellular injury have been reported. Troglitazone has been removed from the market by its manufacturer after the FDA found that the risk of severe liver toxicity associated with the use of troglitazone was unacceptably high compared with the relatively low risk of hepatotoxicity associated with the use of two similar and safer alternatives, rosiglitazone and pioglitazone.
Hepatotoxicity associated with the use of troglitazone has usually been reversible. Hepatic failure leading to liver transplant or death has very rarely been reported.
It is recommended that clinicians choose alternative therapy and that patients who are taking troglitazone discontinue troglitazone therapy after consulting with their prescribing health care provider.[Ref]
Troglitazone (the active ingredient contained in Rezulin) is generally well tolerated with the incidence of adverse effects similar to placebo. Headache, asthenia, dizziness, back pain and nausea are reported slightly more frequently than placebo in clinical trials.[Ref]
Endocrine side effects including hypoglycemia may occur when troglitazone (the active ingredient contained in Rezulin) is used in combination with other hypoglycemic agents such as insulin or sulfonylureas. However, it has not been reported with troglitazone monotherapy.[Ref]
Hematologic effects include small decreases in hemoglobin, hematocrit, and neutrophil counts. These effects typically occur in the first four to eight weeks of therapy and may be related to an increase in plasma volume.[Ref]
Metabolic side effects including small changes in lipid levels may occur in patients receiving troglitazone (the active ingredient contained in Rezulin) [Ref]
1. NeuschwanderTetri BA, Isley WL, Oki JC, Ramrakhiani S, Quiason SG, Phillips NJ, Brunt EM "Troglitazone-induced hepatic failure leading to liver transplantation - A case report." Ann Intern Med 129 (1998): 38-41
2. Neuschwander-Tetre BA, Isley WL, Oki JC, et al. "Troglitazone-induced hepatic failure leading to liver transplantation: a case report." Ann Intern Med 129 (1998): 38-41
3. Watkins PB, Whitcomb RW "Hepatic dysfunction associated with troglitazone." N Engl J Med 338 (1998): 916-7
4. "Product Information. Rezulin (troglitazone)." Parke-Davis, Morris Plains, NJ.
5. Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM "Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone." Ann Intern Med 129 (1998): 36-8
6. Matsumoto K, Miyake S, Yano M, Ueki Y, Tominaga Y "Increase of lipoprotein (a) with troglitazone." Lancet 350 (1997): 1748-9
Some side effects may not be reported. You may report them to the FDA.