Prandin Side Effects

Generic name: repaglinide

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

Some side effects of Prandin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to repaglinide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking repaglinide (the active ingredient contained in Prandin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• seizure (convulsions);

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects of repaglinide may include:

• runny or stuffy nose, sneezing, cough, cold or flu symptoms;

• diarrhea, nausea;

• back pain, headache;

• dizziness;

• blurred vision;

• joint pain; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to repaglinide: oral tablet

General

Repaglinide has been usually well tolerated. Over one year, 13% of patients treated with repaglinide (the active ingredient contained in Prandin) in clinical trials discontinued due to adverse events.

Metabolic

Metabolic side effects have included hypoglycemia, an extension of repaglinide (the active ingredient contained in Prandin) s pharmacologic effects. Hypoglycemia occurred in 16% of patients treated with repaglinide. Patients with liver disease may be at an increased risk of hypoglycemia due to diminished gluconeogenic capacity.

Cardiovascular

Cardiovascular side effects have included angina and chest pain which were reported in 1.8% of patients treated over one year. The overall incidence of other cardiovascular events including hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations was less than 1%.

The incidence of serious cardiovascular adverse events, including ischemia, was higher for repaglinide (the active ingredient contained in Prandin) (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In one year controlled trials, repaglinide was not associated with increased mortality rates compared to rates observed with other oral hypoglycemic agents.

Hypersensitivity

Hypersensitivity side effects during clinical trials involving 2,931 patients include one patient who experienced an anaphylactoid reaction.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, constipation, and dyspepsia which occurred in up to 5% of patients in clinical trials.

Nervous system

Nervous system side effects have included headache which was reported with an incidence of 9% to 11% in patients taking repaglinide (the active ingredient contained in Prandin) compared to 10% in placebo treated patients. Paresthesia was also reported with an incidence of 2% to 3%.

Musculoskeletal

Musculoskeletal side effects have included back pain and arthralgia which were reported in 5% and 6% of patients, respectively.

Respiratory

Respiratory side effects have included upper respiratory infection, sinusitis, rhinitis, and bronchitis which were reported in 2% to 16% of patients. These frequencies were similar to those reported for placebo-treated and sulfonylurea-treated patients.

Hepatic

Hepatic side effects have included elevated liver enzymes which were reported in less than 1% of patients in clinical trials. Additionally, there have been case reports of acute hepatotoxicity and cholestatic hepatitis.

Postmarketing experience has included reports of severe hepatic dysfunction including jaundice and hepatitis.

Hematologic

Hematologic side effects have included thrombocytopenia and leukopenia which were reported in less than 1% of patients.

Ocular

Ocular side effects have included blurred vision and visual disturbances, especially at the initiation of treatment.

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