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Lotensin HCT (Benazepril Hydrochloride / Hydrochlorothiazide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Lotensin HCT has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year.

The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with Lotensin HCT and in 4% of patients treated with placebo.

The most common reasons for discontinuation of therapy with Lotensin HCT in U.S. studies were cough (1.0%; see PRECAUTIONS), “dizziness” (1.0%), headache (0.6%), and fatigue (0.6%). 

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 HCT are shown in the table below.

Reactions Possibly or Probably Drug Related
Patients in U.S. Placebo-Controlled Studies
LOTENSIN HCT
N = 665
Placebo
N = 235
N % N %
“Dizziness” 41 6.3 8 3.4
Fatigue 34 5.2 6 2.6
Postural Dizziness 23 3.5 1 0.4
Headache 20 3.1 10 4.3
Cough 14 2.1 3 1.3
Hypertonia 10 1.5 3 1.3
Vertigo 10 1.5 2 0.9
Nausea 9 1.4 2 0.9
Impotence 8 1.2 0 0.0
Somnolence 8 1.2 1 0.4

Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in 0.3% to 1.0% of patients treated with Lotensin HCT were the following:

Cardiovascular:  Palpitations, flushing.

Gastrointestinal:  Vomiting, diarrhea, dyspepsia, anorexia, and constipation.

Neurologic and Psychiatric:  Insomnia, nervousness, paresthesia, libido decrease, dry mouth, taste perversion, and tinnitus.

Dermatologic:  Rash and sweating.

Other:  Urinary frequency, arthralgia, myalgia, asthenia, and pain (including chest pain and abdominal pain).  

Other adverse experiences reported in 0.3% or more of Lotensin HCT patients in U.S. controlled clinical trials, and rarer events seen in post-marketing experience, were the following; asterisked entries occurred in more than 1% of patients (in some, a causal relationship to Lotensin HCT is uncertain):

Cardiovascular:  Syncope, peripheral vascular disorder, and tachycardia.

Body as a Whole:  Infection, back pain*, flu syndrome*, fever, chills, and neck pain.

Dermatologic: Photosensitivity and pruritus. 

Gastrointestinal:  Gastroenteritis, flatulence, and tooth disorder. 

Neurologic and Psychiatric:  Hypesthesia, abnormal vision, abnormal dreams, and retinal disorder.

Respiratory:  Upper respiratory infection*, epistaxis, bronchitis, rhinitis*, sinusitis*, and voice alteration.

Other:  Conjunctivitis, arthritis, urinary tract infection, alopecia, and urinary frequency*.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of either benazapril or hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:

Benazepril Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombocytopenia, eosinophilic pneumonitis

Hydrochlorothiazide

Digestive: Pancreatitis, small bowel angioedema, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and anorexia.

Neurologic:  Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.

Musculoskeletal:  Muscle spasm.

Hematologic:  Aplastic anemia, agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Metabolic:  Hyperglycemia, glycosuria, and hyperuricemia, pyrexia, asthenia, parathyroid gland changes with hypercalcemia and hypophosphatemia.

Hypersensitivity:  Anaphylactoid reactions, necrotizing angiitis, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity.

Skin: Erythema multiforme including Stevens-Johnson syndrome, and exfoliative dermatitis including toxic epidermal necrolysis.

Clinical Laboratory Test Findings

Serum Electrolytes:  See PRECAUTIONS.

Creatinine and BUN:  Minor reversible increases in serum creatinine and BUN were observed in patients with essential hypertension treated with Lotensin HCT. Such increases occurred most frequently in patients with renal artery stenosis (see PRECAUTIONS).

Drug label data at the top of this Page last updated: 2012-04-15

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