Epaned

Epaned Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Epaned (enalapril) Powder for Oral Solution is an antihypertensive medication used to treat high blood pressure (hypertension). Common side effects include fatigue, dizziness, weakness, cough, and rash.

The recommended initial dose of Epaned in adults is 5 mg once a day, which is adjusted up to a maximum of 40 mg daily as needed to help achieve blood pressure goals. Epaned may interact with nonsteroidal anti-inflammatory drugs (NSAIDs), angiotensin receptor blockers, ACE inhibitors, aliskiren, diuretics, potassium supplements, potassium-containing salt substitutes, lithium, and injectable gold. Tell your doctor all medications and supplements you use. Epaned is not recommended for use during pregnancy. It can harm a fetus. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Epaned (enalapril) Powder for Oral Solution 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 Prescribing information?

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

Epaned FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described elsewhere:

Clinical Trials Experience

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

Enalapril has been evaluated for safety in more than 10,000 patients, including over 1,000 patients treated for one year or more.

In clinical trials, discontinuation of therapy for clinical adverse experiences was required in 3.3% of patients with hypertension and in 5.7% of patients with heart failure.

Adverse reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled clinical trials are shown below. In patients treated with enalapril, the maximum duration of therapy was three years; in placebo treated patients, the maximum duration of therapy was 12 weeks.

Adverse Reactions Occurring in Greater Than 1% of Patients With Hypertension

  Enalapril Maleate Tablets
(n = 2314)
Incidence (discontinuation)
Placebo
(n = 230)
Incidence
Body As A Whole
  Fatigue 3.0 ( < 0.1) 2.6
  Orthostatic Effects 1.2 ( < 0.1) 0
  Asthenia 1.1 (0.1) 0.9
Respiratory
  Cough 1.3 (0.1) 0.9
Skin
  Rash 1.4 (0.4) 0.4

Other Adverse Reactions from Clinical Studies or Postmarketing Experience

The following adverse reactions have been reported in clinical studies or postmarketing experience with enalapril. Because some of these reactions were 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.

Other serious clinical adverse experiences occurring since the drug was marketed or adverse experiences occurring in 0.5 to 1.0% of patients with hypertension or heart failure in clinical trials are listed below and, within each category, are in order of decreasing severity.

Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients [see WARNINGS AND PRECAUTIONS]; pulmonary embolism and infarction; pulmonary edema; rhythm disturbances, including atrial tachycardia and bradycardia; atrial fibrillation; palpitation; Raynaud's phenomenon.

Digestive: Ileus, pancreatitis, melena, anorexia, dyspepsia, constipation, glossitis, stomatitis, dry mouth.

Hematologic: Rare cases of neutropenia, thrombocytopenia, and bone marrow depression.

Musculoskeletal: Muscle cramps.

Nervous/Psychiatric: Depression, confusion, ataxia, somnolence, insomnia, nervousness, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality.

Respiratory: Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection, pulmonary infiltrates, eosinophilic pneumonitis.

Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, pruritus, alopecia, flushing, diaphoresis, photosensitivity.

Special Senses: Blurred vision, taste alteration, anosmia, tinnitus, conjunctivitis, dry eyes, tearing.

Urogenital: Flank pain, gynecomastia, impotence.

Miscellaneous: A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, dermatologic manifestations.

Read the entire FDA prescribing information for Epaned (Enalapril Powder for Oral Solution) »

A A A

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.


Hypertension

Get tips on handling your hypertension.


NIH talks about Ebola on WebMD