Side Effects of Lotensin (benazepril)

Lotensin (benazepril) is an angiotensin converting enzyme (ACE) inhibitor used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent

• strokes,
• heart attacks, and
• kidney problems. 

Lotensin works by relaxing blood vessels so that blood can flow more easily. Lotensin may also be used to treat heart failure or to help protect the kidneys from harm due to diabetes. 

Common side effects of Lotensin include:

• dizziness,
• lightheadedness,
• drowsiness, and headache as your body adjusts to the medication; and
• dry cough.

Serious side effects of Lotensin include:

• fainting,
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat),
• signs of infection (such as fever, chills, persistent sore throat),
• change in the amount of urine,
• serious (possibly fatal) liver problems (symptoms include yellowing eyes/skin, dark urine, severe stomach/abdominal pain, and persistent nausea/vomiting),  
• a very serious allergic reaction (rash, itching/swelling (especially of the face/tongue/throat, severe dizziness, and trouble breathing).

Drug interactions of Lotensin include aliskiren, lithium, and drugs that may increase the level of potassium in the blood (such as angiotensin receptor blockers/ARBs, and birth control pills containing drospirenone). 

Cough-and-cold products, diet aids, and nonsteroidal anti-inflammatory drugs (NSAIDs) may contain ingredients that could increase blood pressure or worsen heart failure when taken with Lotensin. 

Lotensin is not recommended for use during pregnancy; it may harm a fetus. Consult your doctor for more details. Lotensin passes into breast milk. Consult your doctor before breastfeeding.

Benazepril is generally well tolerated and side effects are usually mild and transient.

Side effects include:

• Abdominal pain
• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Headache
• Loss of taste
• Loss of appetite
• Nausea and vomiting
• Easy bruising or bleeding
• Chest pain
• Chills
• Difficulty breathing
• Severe dizziness
• Fainting
• Fever
• Numbness or tingling in the hands or feet
• Rash
• Impotence
• A sore or swollen throat

A dry, persistent cough has been reported with the use of benazepril and other ACE inhibitors. Coughing resolves after discontinuing the medication.

In rare instances, liver dysfunction and skin yellowing (jaundice) have been reported with ACE inhibitors.

Benazepril should not be taken by people with a known allergy to ACE inhibitors.

Swelling of the facial tissues and even the upper airways has been reported with ACE inhibitors on very rare occasions, and can lead to serious breathing difficulties.

In rare instances, low white blood cell counts have been reported with the use of one ACE inhibitor. Low white blood cells increase the patient's risk of infections.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Lotensin has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in Lotensin and placebo patients.

The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg.

Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with Lotensin and in 3% of patients treated with placebo.

The most common reasons for discontinuation were

• headache (0.6%) and
• cough (0.5%).

Adverse reactions seen in at least 1% greater frequency in patients treated with Lotensin than placebo were

• headache (6% vs. 4%),
• dizziness (4% vs. 2%),
• somnolence (2% vs. 0%) and
• postural dizziness (2% vs. 0%).

Adverse reactions reported in controlled clinical trials (less than 1% more on benazepril than on placebo), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Dermatologic: Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.

Gastrointestinal: Nausea, pancreatitis, constipation, gastritis, vomiting, and melena.

Hematologic: Thrombocytopenia and hemolytic anemia.

Neurologic/Psychiatric: Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.

Other: Fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, sweating.

Laboratory Abnormalities

Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes have been reported, as have incidents of hyponatremia, electrocardiographic changes, eosinophilia, and proteinuria.

Diuretics

Hypotension

Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Lotensin. The possibility of hypotensive effects with Lotensin can be minimized by either discontinuing or decreasing the dose of diuretic prior to initiation of treatment with Lotensin.

Hyperkalemia

Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently. Lotensin attenuates potassium loss caused by thiazide-type diuretics.

Antidiabetics

Concomitant administration of Lotensin and antidiabetic medicines (insulins, oral hypoglycemic agents) may increase the risk of hypoglycemia.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including benazepril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving benazepril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including benazepril, may be attenuated by NSAIDs.

Dual Blockade Of The Renin-Angiotensin System (RAS)

Dual Blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Lotensin and other agents that affect the RAS.

Do not coadminister aliskiren with Lotensin in patients with diabetes. Avoid use of aliskiren with Lotensin in patients with renal impairment (GFR < 60 mL/min).

Mammalian Target Of Rapamycin (MTOR) Inhibitors

Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. Monitor for signs of angioedema.

Lithium

Lithium toxicity has been reported in patients receiving lithium concomitantly with Lotensin. Lithium toxicity was usually reversible upon discontinuation of lithium or Lotensin. Monitor serum lithium levels during concurrent use.

Neprilysin Inhibitor

Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.