Lotensin Side Effects

Generic Name: benazepril

Note: This page contains information about the side effects of benazepril. Some of the dosage forms included on this document may not apply to the brand name Lotensin.

Not all side effects for Lotensin 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 benazepril: oral tablet

In addition to its needed effects, some unwanted effects may be caused by benazepril (the active ingredient contained in Lotensin). 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 benazepril:

Less common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • unusual tiredness or weakness
Incidence not known
  • Arm, back, or jaw pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain or discomfort
  • diarrhea
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • fever
  • general feeling of tiredness or weakness
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • rapid breathing
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • tingling of the hands or feet
  • unusual weight gain or loss
  • wheezing

Some of the side effects that can occur with 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:

More common
  • Headache
Less common
  • Cough
  • dizziness
  • sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to benazepril: oral tablet

General

Benazepril has generally been well-tolerated. In large analyses, 20% to 52% of patients experienced an adverse drug event associated with benazepril (the active ingredient contained in Lotensin) but most were mild to moderate and did not require cessation of therapy.[Ref]

Nervous system

Nervous system side effects have included headache (5% to 13%), fatigue (5%), and dizziness (5%). Somnolence or vertigo has been reported in 1% of patients.[Ref]

Respiratory

Respiratory side effects have included eosinophilic pneumonitis which has been reported with other ACE inhibitors.

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

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has been shown with the most data showing some benefit. Other agents studied have included baclofen, theophylline, sulindac, and benzonatate.[Ref]

Respiratory side effects have been unusually reported. An increase in cough or rhinitis has been reported in 2% to 3% of patients. Up to 7% of patients experienced an upper respiratory tract infection during benazepril therapy.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, pancreatitis, constipation, gastritis, vomiting, and melena.[Ref]

A 70 year old man with non-insulin dependent diabetes developed epigastric pain with cramping 30 minutes after taking a single dose of 5 mg benazepril. The same response occurred the following day after the next dose. After the third dose, the man presented to the emergency room with severe epigastric pain, nausea, and vomiting. Serum amylase was 234 units/L and serum lipase was 755 units/L. The signs and symptoms of pancreatitis resolved over the next several days once the drug was discontinued.[Ref]

Cardiovascular

Cardiovascular effects have included postural hypotension or dizziness in 1% of patients. Angioneurotic edema has been reported rarely.[Ref]

Angiotensin converting enzyme (ACE) inhibitors, in general, have been more likely to cause hypotension in sodium depleted or dehydrated patients.

Postural hypotension or dizziness has been more likely to occur with concomitant diuretic therapy.[Ref]

Renal

Renal insufficiency has been more likely to occur in patients with renal artery stenosis, hypovolemia, and sodium depletion.[Ref]

Renal side effects have included renal insufficiency (increase in serum creatinine by 150% above pretreatment value) in 2% of patients.[Ref]

Metabolic

Metabolic side effects including hyperkalemia have been reported.[Ref]

Hyperkalemia is due to inhibition of aldosterone by benazepril.[Ref]

Hypersensitivity

Hypersensitivity side effects including angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. Intestinal angioedema, including small bowel angioedema, has been reported in patients treated with ACE inhibitors, including benazepril (the active ingredient contained in Lotensin) Dermatitis, rash, flushing, and pruritus have been reported. Anaphylactoid reactions have been reported during postmarketing experience.[Ref]

Patients with intestinal angioedema generally presented 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 resolved after stopping the ACE inhibitor.

Hypersensitivity reactions to ACE inhibitors have been life threatening.[Ref]

Hematologic

Hematologic side effects have been rarely reported and have included thrombocytopenia and hemolytic anemia. Agranulocytosis and neutropenia have been reported during postmarketing experience.[Ref]

In two studies, 1 of 2,014 and 1 of 1,357 patients developed decreased hemoglobin during benazepril therapy. Neither patient required stopping the drug.[Ref]

Genitourinary

Genitourinary side effects including frequent urination have been reported during postmarketing experience.[Ref]

Dermatologic

Dermatological side effects have included Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.[Ref]

Psychiatric

Psychiatric side effects have included anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.

Other

Other side effects have included fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, and sweating.

References

1. "Multum Information Services, Inc. Expert Review Panel"

2. Antonios TFT, Macgregor GA "Angiotensin converting enzyme inhibitors in hypertension: potential problems." J Hypertens 13 Suppl (1995): s11-6

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

4. 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

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

6. Alderman CP "Adverse effects of the angiotensin-converting enzyme inhibitors." Ann Pharmacother 30 (1996): 55-61

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. Luque CA, Ortiz MV "Treatment of ACE inhibitor-induced cough." Pharmacotherapy 19 (1999): 804-10

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

10. Semple PF "Putative mechanisms of cough after treatment with angiotensin converting enzyme inhibitors." J Hypertens 13 Suppl (1995): s17-21

11. Muchnick JS, Mehta JL "Angiotensin-converting enzyme inhibitor-induced pancreatitis." Clin Cardiol 22 (1999): 50-1

12. O'Mara NB, O'Mara EM Jr "Delayed onset of andioedema with angiotensin-converting enzyme inhibitors: case report and review of the literature." Pharmacotherapy 16 (1996): 675-9

13. Herings RMC, Deboer A, Stricker BHC, Leufkens HGM, Porsius A "Hypoglycaemia associated with use of inhibitors of angiotensin converting enzyme." Lancet 345 (1995): 1195-8

14. "Product Information. Lotensin (benazepril)." Ciba Pharmaceuticals, Summit, NJ.

15. Tramonti G, Donadio C, Confessore N, Bianchi C "Antihypertensive activity and renal effects of benazepril in humans." Kidney Int (suppl 5) (1996): s107-8

16. 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

17. Gunkel AR, Thurner KH, Kanonier G, Sprinzl GM, Thumfart WF "Angioneurotic edema as a reaction to angiotensin-converting enzyme inhibitors." Am J Otolaryngol 17 (1996): 87-91

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