Inspra Side Effects

Generic name: eplerenone

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

Some side effects of Inspra 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 eplerenone: oral tablet

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

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

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects of eplerenone may include:

• diarrhea, stomach pain;

• cough;

• dizziness;

• tired feeling;

• fever, chills, body aches, flu symptoms;

• vaginal bleeding; or

• breast swelling or tenderness.

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 eplerenone: oral tablet

Metabolic

Metabolic side effects have included hyperkalemia (>5.5 mEq/L). Hyperkalemia was observed in 2.6% of patients with creatinine clearance greater than 100 mL/min, in 5.6% of patients with creatinine clearance of 70 to 100 mL/min, and in 10.4% of patients with creatinine clearance less than 70 mL/min. The principal risk of eplerenone (the active ingredient contained in Inspra) is hyperkalemia, which can result in serious, sometimes fatal arrhythmias.

Other metabolic side effects have included hypercholesterolemia and hypertriglyceridemia in 1% of patients.

Nervous system

Nervous system side effects have included dizziness (3%) and headache. In a pharmacokinetic study, headache was reported in 14% to 63% of patients.

General

General side effects have included fatigue and influenza-like symptoms.

Renal

Renal side effects have included albuminuria in 1% of patients.

Respiratory

Respiratory side effects have included cough in 2% of patients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea in 2% and abdominal pain in 1% of patients.

Endocrine

Endocrine side effects have included gynecomastia (up to 1%) and mastodynia (up to 1.3%) of male patients. Abnormal vaginal bleeding was reported in 2.5% of female patients.

Hepatic

Hepatic side effects have included increases in serum alanine aminotransferase (ALT) and gamma glutamyl transpeptidase (GGT).

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