PrandiMet Side Effects

Please note - some side effects for PrandiMet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of PrandiMet - for the Consumer

PrandiMet

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 PrandiMet:

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

Seek medical attention right away if any of these SEVERE side effects occur when using PrandiMet:

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.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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PrandiMet Side Effects - for the Professional

PrandiMet

Most Frequently Observed Adverse Reactions

Repaglinide

In clinical trials of repaglinide, hypoglycemia is the most common adverse reaction (> 5%) leading to withdrawal of patients treated with repaglinide.

Metformin HCl

Gastrointestinal reactions (e.g., diarrhea, nausea, vomiting) are the most common adverse reactions (> 5%) with metformin HCl treatment and are more frequent at higher metformin HCl doses.

Clinical Trial Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Patients with Inadequate Glycemic Control on Metformin HCl Monotherapy

Table 1 summarizes the most common adverse reactions occurring in a 6-month randomized study of repaglinide added to metformin HCl in patients with type 2 diabetes inadequately controlled on metformin HCl alone.

Table 1: Repaglinide added to metformin HCl in patients with type 2 diabetes inadequately controlled on metformin HCl alone - Adverse reaction reported (regardless of Investigator Assessment of Causality) in ≥10% of patients receiving combination therapy*

* Intent to treat population † There were no cases of severe hypoglycemia (hypoglycemia requiring the assistance of another person)
	Coadministered repaglinide and metformin HCl	Metformin HCl monotherapy	Repaglinide monotherapy
	N (%)	N (%)	N (%)
No. of Patients Exposed	27	27	28
Gastrointestinal System Disorder	9 (33)	13 (48)	10 (36)
Diarrhea	5 (19)	8 (30)	2 (7)
Nausea	4 (15)	2 (7)	1 (4)
Symptomatic Hypoglycemia†	9 (33)	0 (0)	3 (11)
Headache	6 (22)	4 (15)	3 (11)
Upper Respiratory Tract Infection	3 (11)	3 (11)	3 (11)

Cardiovascular Events in repaglinide monotherapy trials

In one-year trials comparing repaglinide to sulfonylurea drugs, the incidence of angina was 1.8% for both treatments, with an incidence of chest pain of 1.8% for repaglinide and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal electrocardiogram, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between repaglinide and the comparator drugs.

The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (51/1228 or 4%) than for sulfonylurea drugs (13/498 or 3%) in controlled clinical trials. In 1-year controlled trials, repaglinide treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies such as glyburide and glipizide.

Seven controlled clinical trials included repaglinide combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or repaglinide plus metformin HCl) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with repaglinide plus NPH-insulin (1.4%) from two studies, and one event in patients using insulin formulations alone from another study (0.3%) [see Warnings and Precautions (5.6)].

Postmarketing Experience

Repaglinide

The following additional adverse reactions have been identified during postapproval use of repaglinide. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or a causal relationship to drug exposure.

Postmarketing experience with repaglinide includes infrequent reports of the following adverse events; alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson Syndrome, and severe hepatic dysfunction including jaundice and hepatitis.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, and vomiting.

Hepatic

Hepatic side effects have included severe hepatic dysfunction including jaundice and hepatitis.

Endocrine

Endocrine side effects have included symptomatic hypoglycemia and pancreatitis.

Nervous system

Nervous system side effects have included headache.

Respiratory

Respiratory side effects have included upper respiratory tract infection.

Hematologic

Hematologic side effects have included hemolytic anemia.

Dermatologic

Dermatologic side effects have included alopecia and Stevens-Johnson Syndrome.

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