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:
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high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
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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:
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diarrhea, stomach pain;
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cough;
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dizziness;
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tired feeling;
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fever, chills, body aches, flu symptoms;
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vaginal bleeding; or
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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).
More Inspra resources
- Inspra Prescribing Information (FDA)
- Inspra MedFacts Consumer Leaflet (Wolters Kluwer)
- Inspra Concise Consumer Information (Cerner Multum)
- Inspra Monograph (AHFS DI)
- Inspra Advanced Consumer (Micromedex) - Includes Dosage Information
- Eplerenone Professional Patient Advice (Wolters Kluwer)
- Eplerenone Prescribing Information (FDA)
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