Amlodipine / benazepril Side Effects
Some side effects of amlodipine / benazepril 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 amlodipine / benazepril: oral capsule
Along with its needed effects, amlodipine / benazepril may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking amlodipine / benazepril:Less common
- dizziness, lightheadedness, or fainting
- fast or irregular heartbeat
- numbness or tingling in the hands, feet, or lips
- shortness of breath
- swelling of the ankles, feet, or lower legs
- weakness or heaviness of the legs
- Bleeding gums
- nausea or vomiting
- pale skin
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain or bloating with fever, nausea, or vomiting
- swelling of the face, mouth, hands, or feet
- trouble with swallowing or breathing (sudden) or hoarseness
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- Chest pain
- pain or burning in the throat
Some side effects of amlodipine / benazepril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Cough (dry and continues)
- feeling of warmth
- redness of the face, neck, arms, and occasionally upper chest
- Acid or sour stomach
- blistering, crusting, irritation, itching, or reddening of the skin
- body aches or pain
- cracked, dry, or scaly skin
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- frequent urination
- inability to have or keep an erection
- increased volume of pale, dilute urine
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- muscle or bone pain
- shakiness in the legs, arms, hands, or feet
- stomach discomfort or upset
- sudden sweating
- tender, swollen glands in the neck
- trembling or shaking of the hands or feet
- trouble with sleeping
- voice changes
For Healthcare Professionals
Applies to amlodipine / benazepril: oral capsule
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.
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 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.
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 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 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 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 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 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 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 side effects have included rare reports of Stevens-Johnson syndrome and pemphigus associated with the benazepril component.
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 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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