Amlodipine and benazepril Side Effects

Please note - some side effects for Amlodipine and benazepril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral capsule

General

Amlodipine-benazepril is generally well-tolerated. Reported side effects are generally mild and transient, and are apparently unrelated to age, sex, race, or duration of therapy. Discontinuation of therapy has been reported in 4% of patients treated with the drug, compared to 3% of patients treated with placebo.

Cardiovascular

ACE inhibitors, in general, are more likely to cause hypotension in sodium depleted or dehydrated patients.

Cardiovascular side effects including dose-dependent peripheral edema have been associated with amlodipine monotherapy in 2% to 5% of patients, but has been observed significantly less often (in only 2% of patients) taking amlodipine in combination with benazepril. Palpitations, postural hypotension, and dizziness have each been reported in approximately 1% of patients receiving either drug alone. Angioneurotic edema is a rare, but potentially serious side effect associated with ACE inhibitors. The occurrence of angioneurotic edema generally requires discontinuation of therapy. Cardiovascular side effects reported postmarketing and associated with the benazepril component have included tachycardia, chest pain, ventricular extrasystole, and palpitations.

Nervous system

Nervous system side effects include headache in 2%, dizziness in 1%, and sleep disturbances, nervousness, anxiety, tremor, and decreased libido, each in less than 1% of patients.

Respiratory

A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme inhibitor therapy due to cough among black patients compared to non-black patients (9.6% vs. 2.4%).

Respiratory side effects are unusual. An increase in cough or rhinitis occurs in 2% to 3% of patients who receive benazepril or amlodipine-benazepril.

Gastrointestinal

Gastrointestinal side effects are unusual, and include nausea, general abdominal pain, dry mouth, constipation, diarrhea, dyspepsia, and esophagitis, each in approximately 1% of patients. As with some other calcium channel blockers, rare cases of gingival hyperplasia have been associated with amlodipine.

Hypersensitivity

Hypersensitivity reactions to 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. 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. Other hypersensitivity reactions associated with ACE inhibitors have included dermatitis, rash, flushing, and pruritus.

A single case of erythema multiforme has been associated with amlodipine.

A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.

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.

Renal

Renal side effects including new or worsened renal insufficiency (defined as an increase in serum creatinine by 150% above pretreatment values) have been reported in 2% of patients who have received benazepril monotherapy. ACE inhibitor-associated renal dysfunction is more likely in patients with renal artery stenosis, hypovolemia, or sodium depletion.

Metabolic

Metabolic side effects including hypokalemia and gout have been reported in less than 1% of patients. Typically, however, hyperkalemia has been associated with ACE inhibitors due to their ability to decrease serum aldosterone concentrations.

Endocrine

Endocrine side effects including a single case of gynecomastia have been associated with the use of amlodipine. The gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent.

Hematologic

Hematologic side effects are rare. There have been rare reports of hemolytic anemia in patients receiving ACE inhibitors.

In two studies, 1 of 2,014 and 1 of 1,357 patients developed decreased hemoglobin concentrations during benazepril monotherapy. Neither patient required discontinuation of the drug.

Dermatologic

Dermatologic side effects have included rare reports of Stevens-Johnson syndrome and pemphigus associated with the benazepril component.

Other

Other side effects reported postmarketing that were associated with the benazepril component have included pancreatitis, hemolytic anemia, thrombocytopenia, gingival hyperplasia, jaundice, neuritis, tinnitus, alopecia, upper respiratory tract infection, and somnolence.

Hepatic

Hepatic side effects reported postmarketing that were associated with the benazepril component have included hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization).

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