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Inspra

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Inspra

Inspra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Inspra (eplerenone) is used to treat congestive heart failure after a heart attack, and is also used to treat high blood pressure (hypertension). It is an aldosterone receptor blocker, which is an antihypertensive. This medication is available in generic form. Common side effects include headache, dizziness, diarrhea, stomach pain, nausea, cough or flu-like symptoms (such as fever, chills, unusual tiredness).

Treatment with Inspra is initiated at 25 mg once daily and adjusted to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Inspra may interact with lithium, other blood pressure medications, antibiotics, antifungals, ACE inhibitors, NSAIDs (non-steroidal anti-inflammatory drugs), HIV/AIDS medicines, or antidepressants. Tell your doctor all medications you are taking. During pregnancy, Inspra should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Inspra (eplerenone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Inspra in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Inspra (Eplerenone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Inspra Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Headache, dizziness, diarrhea, stomach pain, nausea, cough or flu-like symptoms (such as fever, chills, unusual tiredness) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: abnormal vaginal bleeding, enlarged or sore breasts in males, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Inspra (Eplerenone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Inspra FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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

Clinical Trials Experience

Congestive Heart Failure Post-Myocardial Infarction

In EPHESUS, safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients. The overall incidence of adverse events reported with INSPRA (78.9%) was similar to placebo (79.5%). Adverse events occurred at a similar rate regardless of age, gender, or race. Patients discontinued treatment due to an adverse event at similar rates in either treatment group (4.4% INSPRA vs. 4.3% placebo), with the most common reasons for discontinuation being hyperkalemia, myocardial infarction, and abnormal renal function.

Adverse reactions that occurred more frequently in patients treated with INSPRA than placebo were hyperkalemia (3.4% vs. 2.0%) and increased creatinine (2.4% vs. 1.5%). Discontinuations due to hyperkalemia or abnormal renal function were less than 1.0% in both groups. Hypokalemia occurred less frequently in patients treated with INSPRA (0.6% vs. 1.6%). The rates of sex hormone-related adverse events are shown in Table 2.

Table 2: Rates of Sex Hormone-Related Adverse Events in EPHESUS

  Rates in Males Rates in Females
Gynecomastia Mastodynia Either Abnormal Vaginal Bleeding
INSPRA 0.40% 0.10% 0.50% 0.40%
Placebo 0.50% 0.10% 0.60% 0.40%

Hypertension

INSPRA has been evaluated for safety in 3091 patients treated for hypertension. A total of 690 patients were treated for over 6 months and 106 patients were treated for over 1 year.

In placebo-controlled studies, the overall rates of adverse events were 47% with INSPRA and 45% with placebo. Adverse events occurred at a similar rate regardless of age, gender, or race. Therapy was discontinued due to an adverse event in 3% of patients treated with INSPRA and 3% of patients given placebo. The most common reasons for discontinuation of INSPRA were headache, dizziness, angina pectoris/myocardial infarction, and increased GGT. The adverse events that were reported at a rate of at least 1% of patients and at a higher rate in patients treated with INSPRA in daily doses of 25 to 400 mg versus placebo are shown in Table 3.

Table 3: Rates (%) of Adverse Events Occurring in Placebo-Controlled Hypertension Studies in ≥ 1% of Patients Treated with INSPRA (25 to 400 mg) and at a More Frequent Rate than in Placebo-Treated Patients

  INSPRA
(n=945)
Placebo
(n=372)
Metabolic
  Hypercholesterolemia 1 0
  Hypertriglyceridemia 1 0
Digestive
  Diarrhea 2 1
  Abdominal pain 1 0
Urinary
  Albuminuria 1 0
Respiratory
  Coughing 2 1
Central/Peripheral Nervous Syste
   Dizziness 3 2
Body as a Whole
  Fatigue 2 1
  Influenza-like symptoms 2 1
Note: Adverse events that are too general to be informative or are very common in the treated population are excluded.

Gynecomastia and abnormal vaginal bleeding were reported with INSPRA but not with placebo. The rates of these sex hormone-related adverse events are shown in Table 4. The rates increased slightly with increasing duration of therapy. In females, abnormal vaginal bleeding was also reported in 0.8% of patients on antihypertensive medications (other than spironolactone) in active control arms of the studies with INSPRA.

Table 4: Rates of Sex Hormone-Related Adverse Events with INSPRA in Hypertension Clinical Studies

  Rates in Males Rates in Females
Gynecomastia Mastodynia Either Abnormal Vaginal Bleeding
All controlled studies 0.50% 0.80% 1.00% 0.60%
Controlled studies lasting ≥ 6 months 0.70% 1.30% 1.60% 0.80%
Open-label, long-term study 1.00% 0.30% 1.00% 2.10%

Clinical Laboratory Test Findings

Congestive Heart Failure Post-Myocardial Infarction

Creatinine: Increases of more than 0.5 mg/dL were reported for 6.5% of patients administered INSPRA and for 4.9% of placebo-treated patients.

Potassium: In EPHESUS [see Clinical Studies], the frequencies of patients with changes in potassium ( < 3.5 mEq/L or > 5.5 mEq/L or ≥ 6.0 mEq/L) receiving INSPRA compared with placebo are displayed in Table 5.

Table 5: Hypokalemia ( < 3.5 mEq/L) or Hyperkalemia ( > 5.5 or ≥ 6.0 mEq/L) in EPHESUSCongestive Heart Failure Post-Myocardial Infarction

Potassium (mEq/L) INSPRA
(N=3251)
n (%)
Placebo
(N=3237)
n (%)
< 3.5 273 (8.4) 424 (13.1)
> 5.5 508 (15.6) 363 (11.2)
≥ 6.0 180 (5.5) 126 (3.9)

Table 6 shows the rates of hyperkalemia in EPHESUS as assessed by baseline renal function (creatinine clearance).

Table 6: Rates of Hyperkalemia ( > 5.5 mEq/L) in EPHESUS by Baseline Creatinine Clearance*

Baseline Creatinine Clearance INSPRA
(N=508)
n (%)
Placebo
(N=363)
n (%)
≤ 30 mL/min 160 (32) 82 (23)
31-50 mL/min 122 (24) 46 (13)
51-70 mL/min 86 (17) 48 (13)
> 70 mL/min 56 (11) 32 (9)
* Estimated using the Cockroft-Gault formula.

Table 7 shows the rates of hyperkalemia in EPHESUS as assessed by two baseline characteristics: presence/absence of proteinuria from baseline urinalysis and presence/absence of diabetes [see WARNINGS AND PRECAUTIONS].

Table 7: Rates of Hyperkalemia ( > 5.5 mEq/L) in EPHESUS by Proteinuria and History of Diabetes*

  INSPRA
(N=508)
n (%)
Placebo
(N=363)
n (%)
Proteinuria, no Diabetes 81 (16) 40 (11)
Diabetes, no Proteinuria 91 (18) 47 (13)
Proteinuria and Diabetes 132 (26) 58 (16)
* Diabetes assessed as positive medical history at baseline; proteinuria assessed by positive dipstick urinalysis at baseline.

Hypertension

Potassium: In placebo-controlled fixed-dose studies, the mean increases in serum potassium were dose-related and are shown in Table 8 along with the frequencies of values > 5.5 mEq/L.

Table 8: Increases in Serum Potassium in the Placebo-Controlled, Fixed-Dose Hypertension Studies of INSPRA

Daily Dosage n Mean Increase mEq/L % > 5.5 mEq/L
Placebo 194 0 1
25 97 0.08 0
50 245 0.14 0
100 193 0.09 1
200 139 0.19 1
400 104 0.36 8.7

Patients with both type 2 diabetes and microalbuminuria are at increased risk of developing persistent hyperkalemia. In a study of such patients taking INSPRA 200 mg, the frequencies of maximum serum potassium levels > 5.5 mEq/L were 33% with INSPRA given alone and 38% when INSPRA was given with enalapril.

Rates of hyperkalemia increased with decreasing renal function. In all studies, serum potassium elevations > 5.5 mEq/L were observed in 10.4% of patients treated with INSPRA with baseline calculated creatinine clearance < 70 mL/min, 5.6% of patients with baseline creatinine clearance of 70 to 100 mL/min, and 2.6% of patients with baseline creatinine clearance of > 100 mL/min [see WARNINGS AND PRECAUTIONS].

Sodium: Serum sodium decreased in a dose-related manner. Mean decreases ranged from 0.7 mEq/L at 50 mg daily to 1.7 mEq/L at 400 mg daily. Decreases in sodium ( < 135 mEq/L) were reported for 2.3% of patients administered INSPRA and 0.6% of placebo-treated patients.

Triglycerides: Serum triglycerides increased in a dose-related manner. Mean increases ranged from 7.1 mg/dL at 50 mg daily to 26.6 mg/dL at 400 mg daily. Increases in triglycerides (above 252 mg/dL) were reported for 15% of patients administered INSPRA and 12% of placebo-treated patients.

Cholesterol: Serum cholesterol increased in a dose-related manner. Mean changes ranged from a decrease of 0.4 mg/dL at 50 mg daily to an increase of 11.6 mg/dL at 400 mg daily. Increases in serum cholesterol values greater than 200 mg/dL were reported for 0.3% of patients administered INSPRA and 0% of placebo-treated patients.

Liver Function Tests: Serum alanine aminotransferase (ALT) and gamma glutamyl transpeptidase (GGT) increased in a dose-related manner. Mean increases ranged from 0.8 U/L at 50 mg daily to 4.8 U/L at 400 mg daily for ALT and 3.1 U/L at 50 mg daily to 11.3 U/L at 400 mg daily for GGT. Increases in ALT levels greater than 120 U/L (3 times upper limit of normal) were reported for 15/2259 patients administered INSPRA and 1/351 placebo-treated patients. Increases in ALT levels greater than 200 U/L (5 times upper limit of normal) were reported for 5/2259 of patients administered INSPRA and 1/351 placebo-treated patients. Increases of ALT greater than 120 U/L and bilirubin greater than 1.2 mg/dL were reported 1/2259 patients administered INSPRA and 0/351 placebo-treated patients. Hepatic failure was not reported in patients receiving INSPRA.

BUN/Creatinine: Serum creatinine increased in a dose-related manner. Mean increases ranged from 0.01 mg/dL at 50 mg daily to 0.03 mg/dL at 400 mg daily. Increases in blood urea nitrogen to greater than 30 mg/dL and serum creatinine to greater than 2 mg/dL were reported for 0.5% and 0.2%, respectively, of patients administered INSPRA and 0% of placebo-treated patients.

Uric Acid: Increases in uric acid to greater than 9 mg/dL were reported in 0.3% of patients administered INSPRA and 0% of placebo-treated patients.

Postmarketing Experience

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

Skin: angioneurotic edema, rash

Read the entire FDA prescribing information for Inspra (Eplerenone) »

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Inspra - User Reviews

Inspra User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Inspra sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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