Rezulin Side Effects

Generic name: troglitazone

Note: This document contains side effect information about troglitazone. Some dosage forms listed on this page may not apply to the brand name Rezulin.

Applies to troglitazone: oral tablet.

Stop taking troglitazone (the active ingredient contained in Rezulin) and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

In rare cases, troglitazone has caused severe liver damage resulting in death or liver transplant. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.

Although troglitazone does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to troglitazone: oral tablet.

Hepatic

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 (the active ingredient contained in Rezulin) 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]

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]

General

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

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

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

Metabolic side effects including small changes in lipid levels may occur in patients receiving troglitazone (the active ingredient contained in Rezulin) ^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer