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Lotensin

Last reviewed on RxList: 2/10/2015
Lotensin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/12/2016

Lotensin (benazepril hydrochloride) is an angiotensin-converting enzyme (ACE) inhibitor used to treat patients with high blood pressure (hypertension). Lotensin is available in generic form. Common side effects of Lotensin are:

  • dizziness,
  • cough,
  • headache,
  • nausea,
  • vomiting,
  • constipation,
  • drowsiness,
  • dizziness,
  • lightheadedness,
  • tired feeling,
  • anxiety,
  • sleep problems (insomnia),
  • flushing (warmth, redness, or tingly feeling),
  • itching, or
  • skin rash.

Serious side effects of Lotensin include:

  • fainting,
  • changes in urine output,
  • blistering red skin rash,
  • unusual tiredness,
  • easy bruising or bleeding, or
  • serious flu-like symptoms.

Lotensin is supplied as tablets containing strengths of 5, 10, 20, and 40 mg of benazepril hydrochloride for oral administration. The usual starting dose is 10 mg per day. Lotensin may interact with salt substitutes or potassium supplements, other blood pressure medications, gold injections, insulin or oral diabetes medications, lithium, or diuretics (water pills). Tell your doctor all medications and supplements you use. Lotensin should not be used in pregnant females as it may damage the fetus. The drug has been found in breast milk so use in breastfeeding women must be weighed against the possible harm to the infant. Lotensin is not recommended for children under 6 years old. However, doses of Lotensin between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure. Consequently, the recommended starting dose of Lotensin in children 6 years and older is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg have not been studied in children 6 years and older.

Our Lotensin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lotensin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may be more likely to have an allergic reaction to benazepril if you are African-American.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urinating;
  • swelling or rapid weight gain;
  • fever, chills, body aches, flu symptoms;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • jaundice (yellowing of the skin or eyes);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • cough;
  • headache;
  • dizziness, drowsiness, tired feeling;
  • anxiety, sleep problems (insomnia);
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, constipation; or
  • mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lotensin (Benazepril)

Lotensin Professional Information

SIDE EFFECTS

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
Somnolence 15 1.6 2 0.4
Postural Dizziness 14 1.5 1 0.2

Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients or with less than 1% difference in incidence between benazepril or placebo treatment), 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 and 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.

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

Pediatric Patients: The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.

Clinical Laboratory Test Findings

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): Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes (see WARNINGS) have been reported, as have scattered incidents of hyponatremia, electrocardiographic changes, eosinophilia, and proteinuria.

Read the entire FDA prescribing information for Lotensin (Benazepril)

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