Inspra Side Effects

Generic Name: eplerenone

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

Not all side effects for Inspra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to eplerenone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by eplerenone (the active ingredient contained in Inspra). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking eplerenone:

Less common
  • Excess of cholesterol in the blood
  • excess of triglycerides in the blood
Incidence not known
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • difficulty with breathing
  • dizziness
  • fast or irregular heartbeat
  • headache
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • rash
  • shortness of breath
  • sweating
  • vomiting
  • weakness or heaviness of the legs

Some of the side effects that can occur with eplerenone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Abnormal vaginal bleeding
  • breast pain
  • chills
  • cloudy urine
  • cough
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • swelling of the breasts or breast soreness in both females and males
  • unusual tiredness or weakness

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.[Ref]

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.[Ref]

General

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

Renal

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

Respiratory

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

Gastrointestinal

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

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.[Ref]

Hepatic

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

References

1. Zillich AJ, Carter BL "Eplerenone - a novel selective aldosterone blocker." Ann Pharmacother 36 (2002): 1567-76

2. "Product Information. Inspra (eplerenone)." Searle, Chicago, IL.

3. Ravis WR, Reid S, Sica DA, Tolbert DS "Pharmacokinetics of eplerenone after single and multiple dosing in subjects with and without renal impairment." J Clin Pharmacol 45 (2005): 810-21

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