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

Applies to metformin / repaglinide: oral tablet.

Gastrointestinal

Repaglinide-Metformin:

Very common (10% or more): Gastrointestinal system disorder (33%), diarrhea (19%), nausea (15%)

Repaglinide:

Very common (10% or more): Gastrointestinal system disorder (36%)

Common (1% to 10%): Diarrhea, nausea

Postmarketing reports: Pancreatitis

Metformin:

Very common (10% or more): Gastrointestinal system disorder (48%), diarrhea (30%)

Common (1% to 10%): Nausea^[Ref]

Hepatic

Repaglinide:

Postmarketing reports: Severe hepatic dysfunction including jaundice and hepatitis^[Ref]

Nervous system

Frequency not reported: Headache^[Ref]

Respiratory

Repaglinide-Metformin:

Very common (10% or more): Upper respiratory tract infection (11%)

Repaglinide:

Very common (10% or more): Upper respiratory tract infection (11%)

Metformin:

Common (1% to 10%): Upper respiratory tract infection (11%)^[Ref]

Hematologic

Repaglinide:

Postmarketing reports: Hemolytic anemia^[Ref]

Dermatologic

Repaglinide:

Postmarketing reports: Stevens-Johnson syndrome, alopecia^[Ref]

Cardiovascular

Cardiovascular events were evaluated in trials comparing repaglinide to sulfonylureas. Serious cardiovascular events including ischemia with this drug were higher at 4% (51/1228) than for sulfonylurea drugs (3%; 13/498). No excess mortality was associated with this increase. Selected cardiovascular events including hypertension, abnormal EKG, MI, arrhythmias, and palpitations were observed at 1% or less and no more frequently with this drug than with comparator drugs.

Across 7 repaglinide clinical trials, 6 serious events of myocardial ischemia occurred in combination use with NPH-insulin compared with 1 event in patients using insulin alone. Repaglinide should not be used in combination with NPH insulin.

Repaglinide:

Common (1% to 10%): myocardial ischemia, angina, chest pain

Frequency not reported: Hypertension, abnormal EKG, MI, arrhythmias, palpitations

General

The most frequently reported adverse reactions included hypoglycemia and headache.

Metabolic

Repaglinide-Metformin:

Very common (10% or more): Symptomatic hypoglycemia (33%)

Repaglinide:

Very common (10% or more): Symptomatic hypoglycemia (11%)

Metformin:

Common (1% to 10%): Subnormal vitamin B12 levels

Rare (less than 0.1%): Lactic acidosis