Diltiazem / enalapril Side Effects

Some side effects of diltiazem / enalapril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diltiazem / enalapril: oral tablet extended release

If you experience any of the following serious side effects, stop taking diltiazem and enalapril and call your doctor immediately or seek emergency medical treatment:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  • jaundice (yellowing of your skin or eyes);

  • unusually fast or slow heartbeats;

  • difficulty breathing;

  • abnormal behavior or psychosis;

  • swelling of your legs or ankles;

  • little or no urine;

  • chest pain; or

  • severe dizziness or fainting.

Other, less serious side effects may be more likely to occur. Continue to take diltiazem and enalapril and talk to your doctor if you experience

  • mild dizziness or lightheadedness;

  • headache;

  • dry, tickling cough;

  • flushing (redness);

  • insomnia and vivid dreams;

  • numbness or tingling in the hands, feet, arms, or legs;

  • nausea, constipation, or diarrhea;

  • weakness or fatigue; or

  • a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to diltiazem / enalapril: oral tablet extended release

General

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

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.

Cardiovascular

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 diltiazem has rarely resulted in angina pectoris, myocardial infarction, and stroke. Palpitations have been rarely reported.

Angioedema associated with the use of ACE inhibitors may be a sign of allergy and is generally an indication to discontinue therapy with this agent and to avoid other ACE inhibitors. 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.

Respiratory

Respiratory side effects including cough is a common respiratory system complaint associated with ACE inhibitors that occurs in approximately 3% of patients who are taking this combination drug. Nasal congestion, pharyngitis, pulmonary infiltrates and bronchitis have rarely been reported.

Metabolic

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

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.

Renal

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

Hypersensitivity

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.

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.

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.

Gastrointestinal

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

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

Musculoskeletal

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

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.

Rare cases of hemolytic anemia have been reported in patients who are taking enalapril, particularly patients with G-6-PD deficiency.

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, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash, and other dermatologic manifestations.

Genitourinary

Genitourinary complaints including impotence among male patients are extremely rare.

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