Inspra Side Effects

Generic Name: eplerenone

Please note - some side effects for Inspra 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 Inspra - for the Consumer

Inspra

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 Inspra:

Cough; diarrhea; dizziness; flu-like symptoms (fever, chills, muscle ache, tiredness); headache; stomach pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal discharge; chest pain; enlarged or swollen breasts; irregular heartbeat; severe muscle weakness.

Inspra Side Effects - for the Professional

Inspra

CHF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine. (6.1)

Hypertension: Most common adverse reactions (≥2% and more frequent than with placebo): dizziness, diarrhea, coughing, fatigue and flu-like symptoms. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

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 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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