Repaglinide Side Effects

Brand Names: Prandin

Please note - some side effects for Repaglinide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Repaglinide - for the Consumer

Repaglinide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Repaglinide:

Changes in vision; diarrhea; headache; increased heartbeat; increased hunger; joint or back pain; nasal or chest congestion; nervousness; sinus inflammation; sweating; tiredness; tremor.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain.

Repaglinide/Metformin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Repaglinide/Metformin:

Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dark urine; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness; yellowing of the skin or eyes.

Side Effects by Body System

General

Repaglinide has been usually well tolerated. Over one year, 13% of patients treated with repaglinide in clinical trials discontinued due to adverse events.

Metabolic

Metabolic side effects have included hypoglycemia, an extension of repaglinide'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 (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 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.

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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