Amlodipine / benazepril Side Effects

Not all side effects for amlodipine / benazepril 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 amlodipine / benazepril: oral capsule

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

Less common
  • Confusion
  • dizziness, lightheadedness, or fainting
  • fast or irregular heartbeat
  • nervousness
  • 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
Rare
  • Bleeding gums
  • chills
  • fever
  • nausea or vomiting
  • nosebleeds
  • 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
Incidence not known
  • Chest pain
  • heartburn
  • pain or burning in the throat

Some of the side effects that can occur with amlodipine / benazepril 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:

Less common
  • Cough (dry and continues)
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally upper chest
  • sleepiness
Incidence not known
  • Acid or sour stomach
  • belching
  • 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
  • indigestion
  • 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
  • swelling
  • 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

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.[Ref]

Cardiovascular

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

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.[Ref]

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.[Ref]

Respiratory

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

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%).[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

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.[Ref]

Dermatologic

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

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).

References

1. Kuschnir E, Acuna E, Sevilla D, Vasquez J, Bendersky M, Resk J, Glazer R "Treatment of patients with essential hypertension: amlodipine 5 mg/ benazepril 20 mg compared with amlodipine 5 mg, benazepril 20 mg, and placebo." Clin Ther 18 (1996): 1213-24

2. "Product Information. Lotrel (amlodipine-benazepril)." Ciba Pharmaceuticals, Summit, NJ.

3. Chahine RA, Feldman RL, Giles TD, Nicod P, Raizner AE, Weiss RJ, Vanov SK "Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group." J Am Coll Cardiol 21 (1993): 1365-70

4. Grandinetti O, Feraco E "Middle term evaluation of amlodipine vs nitrendipine: efficacy, safety and metabolic effects in elderly hypertensive patients." Clin Exp Hypertens 15 (1993): 197-210

5. Esin RA, Essien OE, Andy J "Amlodipine in the treatment of mild-to-moderate essential hypertension." Curr Ther Res Clin Exp 55 (1994): 1112-6

6. Frishman WH, Ram CVS, Mcmahon FG, Chrysant SG, Graff A, Kupiec JW, Hsu H "Comparison of amlodipine and benazepril monotherapy to amlodipine plus benazepril in patients with systemic hypertension: a randomized, double-blind, placebo-controlled, parallel-group study." J Clin Pharmacol 35 (1995): 1060-6

7. Balfour J, Goa K "Benazepril: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in hypertension and congestive heart failure." Drugs 42 (1991): 511-39

8. Haria M, Wagstaff AJ "Amlodipine. A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease." Drugs 50 (1995): 560-86

9. MacNab M, Mallows S "Safety profile of benazepril in essential hypertension." Clin Cardiol 14 Suppl I (1991): iv33-7

10. Holwerda K, Hoogma RP, Oldenbroek C, Huige RC, Wester A, Rijnierse JM "Efficacy and safety of benazepril plus hydrochlorothiazide versus benazepril alone in hypertensive patients unresponsive to benazepril monotherapy." Clin Ther 16 (1994): 942-51

11. Saruta T, Ishii M, Abe K, Iimura I "Efficacy and safety of amlodipine in hypertensive patients with renal dysfunction." Clin Cardiol 17 (1994): 317-24

12. Whalen JJ "Definition of the effective dose of the converting-enzyme inhibitor benazepril." Am Heart J 117 (1989): 728-34

13. Elliott WJ "Higher incidence of discontinuation of angiotensin converting enzyme inhibitors due to cough in black subjects." Clin Pharmacol Ther 60 (1996): 582-8

14. Ellis JS, Seymour RA, Thomason JM, Monkman SC, Idle JR "Gingival sequestration of amlodipine and amlodipine-induced gingival overgrowth." Lancet 341 (1993): 1102-3

15. Steele RM, Schuna AA, Schreiber RT "Calcium antagonist-induced gingival hyperplasia." Ann Intern Med 120 (1994): 663-4

16. Bewley AP, Feher MD, Staughton RC "Erythema multiforme following substitution of amlopidine for nifedipine." BMJ 307 (1993): 241

17. Velussi M, Brocco E, Frigato F, Zolli M, Muollo B, Maioli M, Carraro A, Tonolo G, Fresu P, Cernigoi AM, Fioretto P, Nosadini R "Effects of cilazapril and amlodipine on kidney function in hypertensive NIDDM patients." Diabetes 45 (1996): 216-22

18. Zochling J, Large G, Fassett R "Gynaecomastia and amlodipine." Med J Aust 160 (1994): 807

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)