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Lotensin (Benazepril Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 comparable 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%) (see PRECAUTIONS, Cough).

The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Lotensin are shown below.

PATIENTS IN U.S. PLACEBO-CONTROLLED STUDIES
LOTENSIN
(N=964)
PLACEBO
(N=496)
N % N %
Headache 60 6.2 21 4.2
Dizziness 35 3.6 12 2.4
Fatigue 23 2.4 11 2.2
Somnolence 15 1.6 2 0.4
Postural Dizziness 14 1.5 1 0.2
Nausea 13 1.3 5 1.0
Cough 12 1.2 5 1.0

Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Cardiovascular: Symptomatic hypotension was seen in 0.3% of patients, postural hypotension in 0.4%, and syncope in 0.1%; these reactions led to discontinuation of therapy in 4 patients who had received benazepril monotherapy and in 9 patients who had received benazepril with hydrochlorothiazide (see PRECAUTIONS and WARNINGS). Other reports included angina pectoris, palpitations, and peripheral edema.

Renal: Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Lotensin, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine.

Angioedema: Angioedema has been reported in patients receiving ACE inhibitors. During clinical trials in hypertensive patients with benazepril, 0.5% of patients experienced edema of the lips or face without other manifestations of angioedema. Angioedema associated with laryngeal edema and/or shock may be fatal. If angioedema of the face, extremities, lips, tongue, or glottis and/or larynx occurs, treatment with Lotensin should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

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

Gastrointestinal: Pancreatitis, constipation, gastritis, vomiting, and melena.

Hematologic: Thrombocytopenia and hemolytic anemia.

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

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

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.

Pediatric Patients: The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients. Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development.

The long-term effects of benazepril on growth and development have not been studied.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen: Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Lotensin, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis (see PRECAUTIONS, General).

Potassium: Since benazepril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient’s serum potassium should be monitored frequently (see PRECAUTIONS).

Hemoglobin: Decreases in hemoglobin (a low value and a decrease of 5 g/dL) were rare, occurring in only 1 of 2,014 patients receiving Lotensin alone and in 1 of 1,357 patients receiving Lotensin plus a diuretic. No U.S. patients discontinued treatment because of decreases in hemoglobin.

Other (causal relationships unknown): Clinically important changes in standard laboratory tests were rarely associated with Lotensin administration. Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes (see WARNINGS) have been reported, as have scattered incidents of hyponatremia, electrocardiographic changes, leukopenia, eosinophilia, and proteinuria. In U.S. trials, less than 0.5% of patients discontinued treatment because of laboratory abnormalities.



REPORTS OF SUSPECTED LOTENSIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lotensin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lotensin side effects / adverse reactions in 47 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2011-11-25

Patient: 47 year old female

Reactions: Blood Bilirubin Increased, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Blood Bilirubin Unconjugated Increased, Aspartate Aminotransferase Increased, Bilirubin Conjugated Increased, Hepatitis

Suspect drug(s):
Lotensin
    Dosage: 5 mg, qd

Lotensin
    Dosage: 10 mg, qd
    Indication: Hypertension



Possible Lotensin side effects / adverse reactions in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14

Patient: 76 year old female

Reactions: Suicidal Ideation

Adverse event resulted in: death

Suspect drug(s):
Lotensin

Quetiapine

Metoprolol Tartrate

Colchicine

Valproic Acid

Isradipine

Clonazepam



Possible Lotensin side effects / adverse reactions in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14

Patient: 76 year old female

Reactions: Suicidal Ideation

Adverse event resulted in: death

Suspect drug(s):
Metoprolol Tartrate

Clonazepam

Quetiapine

Lotensin

Colchicine

Isradipine

Valproic Acid



See index of all Lotensin side effect reports >>

Drug label data at the top of this Page last updated: 2012-03-01

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