Enalapril / felodipine Side Effects

Not all side effects for enalapril / felodipine 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 enalapril / felodipine: oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by enalapril / felodipine. 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 enalapril / felodipine:

Less common
  • Dizziness, lightheadedness, or fainting
  • swelling of ankles, feet, or lower legs
Rare
  • Chills, fever, and sore throat
  • swelling of face, mouth, hands, or feet
  • trouble in swallowing or breathing (sudden), accompanied by hoarseness
  • unusual bleeding or bruising
  • yellow eyes or skin
Signs and symptoms of too much potassium in the body
  • Confusion
  • irregular heartbeat
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • weakness or heaviness of legs

Some of the side effects that can occur with enalapril / felodipine 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:

More common
  • Headache
Less common
  • Cough (dry, persistent)
  • flushing
  • swelling of the gums
  • unusual tiredness

For Healthcare Professionals

Applies to enalapril / felodipine: oral tablet extended release

General

In general, side effects associated with this combination drug are similar to those associated with each component. There do not appear to be side effects unique to the combination drug. Side effects are typically mild and transient.[Ref]

Nervous system

Nervous system side effects include headache in 3% to 7% (less than placebo), dizziness in approximately 3%, and asthenia/fatigue in approximately 3% of patients. Depression, sleeping problems (either insomnia or somnolence), ataxia, confusion, peripheral neuropathy, taste alterations, tinnitus, tearing, amblyopia, eye irritation, retinopathy, and vertigo have been reported in less than 1% of patients.[Ref]

Cardiovascular

Angioedema associated with the use of ACE inhibitors may be a sign of allergy and may be an indication to discontinue therapy with this agent or any other ACE inhibitor. Angioedema that involves the face, larynx, or neck IS an absolute contraindication to therapy. The incidence of angioedema appears slightly higher in black than in non-black patients.[Ref]

Cardiovascular side effects may be related to either component, and include edema or swelling in 3% and chest pain (relationship to drug questionable) in 0.5% to 1.6%. Calcium channel blockade can rarely result in bradycardia, AV block (1st, 2nd, and even 3rd-degree AV block), heart failure, and hypotension. Excessive hypotension related to either enalapril or felodipine has rarely resulted in angina pectoris, myocardial infarction, or stroke. Palpitations have been rarely reported.[Ref]

Respiratory

Respiratory side effects including cough occur in approximately 3% of patients. Nasal congestion, pharyngitis, pulmonary infiltrates and bronchitis have rarely been reported.[Ref]

Metabolic

Metabolic side effects are related to enalapril. By inhibiting angiotensin II-mediated aldosterone secretion, ACE inhibitors can induce mild hyperkalemia, particularly in patients with renal insufficiency.[Ref]

Less common metabolic problems (associated with felodipine) include hyperglycemia, hyperuricemia (with rare cases of gout), hypokalemia, and increased creatine kinase.[Ref]

Renal

Renal side effects including new or worsened renal insufficiency have been associated with ACE inhibitors. Patients at increased risk include patients with heart failure, renal insufficiency, and renal artery stenosis.[Ref]

Hypersensitivity

Late-onset enalapril-induced angioedema (more than three months) is reported in at least one patient who had taken enalapril without incident for three years. Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.[Ref]

Hypersensitivity reactions to enalapril, as with some other angiotensin converting enzyme (ACE) inhibitors, may be life-threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. Obstructive laryngeal and glossal angioedema due to enalapril is a rare, but potentially fatal reaction. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general. Enalapril is not recommended for patients with a history of idiopathic angioedema.

Other hypersensitivity reactions associated with enalapril including photosensitivity in 0.1%, or urticaria in 0.3% of patients have been reported. A single case of Henoch-Schonlein purpura has also been reported.[Ref]

Dermatologic

Dermatologic side effects are typically mild. Rashes have been reported in 2% of patients. The following side effects have rarely been associated with either or both drugs when given alone: alopecia, diaphoresis, erythema multiforme, exfoliative dermatitis, pemphigus, photosensitivity, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Hypersensitivity reactions to ACE inhibitors can present as angioedema and severe rash.[Ref]

Gastrointestinal

Gastrointestinal problems, such as nausea and diarrhea, have been reported in up to 2% of patients. These side effects were prevalent among placebo-treated patients in controlled trials.[Ref]

Rarely, constipation, anorexia, dry mouth, dyspepsia, glossitis, and cholestatic jaundice/hepatitis, pancreatitis, ileus, stomatitis, vomiting, gingival hyperplasia (related to the use of some calcium channel blockers) have been associated with the use of enalapril or felodipine.[Ref]

Musculoskeletal

Musculoskeletal discomfort has been reported in up to 1% of patients.[Ref]

Hematologic

Hematologic side effects are rare, and are remarkable for rare cases of agranulocytosis in patients who are taking ACE inhibitors. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia. Thrombocytopenia has also rarely been reported.[Ref]

Rare cases of hemolytic anemia have been reported in patients who are taking enalapril, particularly patients with G6PD deficiency.[Ref]

Immunologic

Immunologic side effects have been rarely associated with the use of enalapril. This complex may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgias/arthritis, myalgias/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash, and other dermatologic manifestations.[Ref]

Genitourinary

Genitourinary complaints including impotence among male patients are extremely rare.[Ref]

Hepatic

Hepatic side effects associated with the use of ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop.[Ref]

References

1. Anderson A, Morgan TO "Response of patients to enalapril, felodipine and their combination." J Hypertens Suppl 9 (1991): s380-1

2. "Product Information. Lexxel (enalapril-felodipine)." Astra Pharmaceuticals, Wayne, PA.

3. "Felodipine--another calcium-channel blocker for hypertension." Med Lett Drugs Ther 33 (1991): 115-6

4. Yedinak KC, Lopez LM "Felodipine: a new dihydropyridine calcium-channel antagonist." DICP 25 (1991): 1193-206

5. Todd PA, Faulds D "Felodipine: a review of the pharmacology and therapeutic use of the extended release formulation in cardiovascular disorders." Drugs 44 (1992): 251-77

6. Cambell LM, Ross JR, Goves JR, Lees CT, McCullagh A, Barnes P, Timerick SJ, Richardson PD "A dose-finding, placebo-controlled study on extended-release felodipine once daily in treatment of hypertension." J Cardiovasc Pharmacol 14 (1989): 869-73

7. Cutler SA, Hammond JJ "A multicenter comparison of isradipine and felodipine in the treatment of mild-to-moderate hypertension. The Physician's Study Group." Am J Hypertens 6 (1993): s44-8

8. Gradman AH, Cutler NR, Davis PJ, Robbins JA, Weiss RJ, Wood BC, Michelson EL "Long-term efficacy, tolerability, and safety of the combination of enalapril and felodipine ER in the treatment of hypertension." Clin Ther 20 (1998): 527-38

9. Achilli F, Buono G, Difraia S, Dolara A, Raffo M, Montereggi A, Ravera E, Valagussa F "Acute and chronic effects of felodipine extended release and amlodipine in patients with exertional angina: a double-masked, clinical comparison." Curr Ther Res Clin Exp 57 (1996): 523-36

10. Morgan TO, Anderson A, Jones E "Comparison and interaction of low dose felodipine and enalapril in the treatment of essential hypertension in elderly subjects." Am J Hypertens 5 (1992): 238-43

11. Lorimer AR, Pringle SD "The safety of felodipine." J Cardiovasc Pharmacol 15 (1990): s85-9

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