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Rezulin

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Rezulin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Rezulin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rezulin (troglitazone) is an oral antihyperglycemic agent used to help those with type 2 diabetes respond better to insulin and to reduce the amount of sugar produced by the liver. Rezulin in no longer available in the United States. It may still be available in generic form. Rare but serious side effects of Rezulin include severe liver damage and allergic reactions such as difficulty breathing, closing of throat, swelling of lips, tongue, face, and hives.

Dosage of Rezulin is 200 mg, 400 mg, or 600 mg daily. Talk to your doctor about your individual recommended dose. Tell your doctor about all medications you are taking, especially if you are taking medication such as Questran, Seldane, and birth control pills as these may interact with Rezulin. Avoid drinking alcohol while taking Rezulin. Your liver will need to be monitored via blood tests by your doctor before and after treatment to avoid serious liver damage. You should not take Rezulin if you are pregnant or breastfeeding.

Our Rezulin (troglitazone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rezulin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Two patients in the clinical studies developed reversible jaundice: one of these patients had a liver biopsy which was consistent with an idiosyncraticdrug reaction. An additional patient had a liver biopsy associated which was also consistent with an Idiosyncratic drug reaction. Symptoms that are with hepatic dysfunction have been reported, including: nausea, vomitin abdominal pain, fatigue, anorexia, dark urine, abnormal liver function tests (including increased ALT, AST, LDH, alkaline phosphatase, bilirubin). Also see WARNINGS.

The overall incidence and types of adverse reactions reported in placebo- controlled clinical trials for Rezulin (troglitazone (removed from the us market 3/21/00)) - treated patients and placebo- treated patients are shown in Table 6. In patients treated with Rezulin (troglitazone (removed from the us market 3/21/00)) in glyburide- controlled studies (N= 550) or uncontrolled studies (N= 510), the safety profile of Rezulin (troglitazone (removed from the us market 3/21/00)) appeared similar to that displayed in Table 6. The incidence of withdrawals during clinical trials was similar for patients treated with placebo or Rezulin (troglitazone (removed from the us market 3/21/00)) (4%).

TABLE 6.

North American Placebo- Controlled Clinical Studies:

Adverse Events Reported at a Frequency > 5% of Rezulin (troglitazone (removed from the us market 3/21/00)) - Treated Patients

% of Patients

 

Placebo

N = 492

Rezulin (troglitazone (removed from the us market 3/21/00))

N = 1450

 

Placebo

N = 492

Rezulin (troglitazone (removed from the us market 3/21/00))

N = 1450

Infection

22

18

Nausea

4

6

Headache

11

11

Rhinitis

7

5

Pain

14

10

Diarrhea

6

5

Accidental Injury

6

8

Urinary Tract Infection

6

5

Asthenia

5

6

Peripheral Edema

5

5

Dizziness

5

6

Pharyngitis

4

5

Back Pain

4

6

. . .


Types of adverse events seen when Rezulin (troglitazone (removed from the us market 3/21/00)) was used concomitantly with insulin (N= 543) were similar to those during Rezulin (troglitazone (removed from the us market 3/21/00)) monotherapy (N= 1731), although hypoglycemia occurred on insulin combination therapy (see PRECAUTIONS).

Laboratory Abnormalities

Hematologic: Small decreases in hemoglobin, hematocrit, and neutrophil counts (within the normal range) were more common in Rezulin (troglitazone (removed from the us market 3/21/00)) -treated than placebo-treated patients and may be related to increased plasma volume observed with Rezulin (troglitazone (removed from the us market 3/21/00)) treatment. Hemoglobin decreases to below the normal range occurred in 5% of Rezulin (troglitazone (removed from the us market 3/21/00)) -treated and 4 % of placebo-treated patients.

Lipids: Small changes in serum lipids have been observed (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical effects).

Serum Transaminase Levels: During all clinical studies in North America, a total of 48 of 2510 (1.9%) Rezulin (troglitazone (removed from the us market 3/21/00)) -treated patients and 3 of 475 (0.6%) placebo-treated patients had ALT levels greater than 3 times the upp er limit of normal. During controlled clinical trials. 2.2% of Rezulin (troglitazone (removed from the us market 3/21/00)) treated patients had reversible elevations in AST or ALT greater than 3 times the upper limit of normal, compared with 0.6% of patients receiving placebo. Hyperbilirubinemia (> 1.25 upper limit of normal) was found in 0.7% of Rezulin (troglitazone (removed from the us market 3/21/00)) -treated patients compared with 1.7% of patients receiving placebo. In the population of patients treated with Rezulin (troglitazone (removed from the us market 3/21/00)) , mean and median values for bilirubin, AST, ALT, alkaline phosphatase, and GGT were decreased at the final visit compared with baseline, while values or LDH were increased slightly (see WARNINGS).

Postintroduction Reports

Adverse events associated with Rezulin (troglitazone (removed from the us market 3/21/00)) that have been reported since market introduction, that are not listed above, and for which causal relationship to drug has not been established include the following congestive heart failure, weight gain, edema, fever, abnormal lab tests including increased CPK and creatinine, hyperglycemia, syncope, anemia, malaise.

Read the entire FDA prescribing information for Rezulin (Troglitazone (removed from the US market 3/21/00)) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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