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Zestril

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Zestril

Zestril

Zestril Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Zestril (lisinopril) is a drug of the angiotensin-converting enzyme (ACE)-inhibitor class and is used to treat high blood pressure (hypertension), congestive heart failure, and to improve survival after a heart attack. Side effects can include cough, dizziness, nausea, vomiting, and mild skin rash. Other side effects may occur. Zestril is taken orally in tablet form.

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. It is not known whether this drug is excreted in human milk.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zestril in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • urinating more or less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • chest pain; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • cough;
  • dizziness, drowsiness, headache;
  • depressed mood;
  • nausea, vomiting, diarrhea, upset stomach; 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 Zestril (Lisinopril) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zestril Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, tiredness, or headache may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle weakness, signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zestril (Lisinopril)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zestril FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ZESTRIL has been found to be generally well tolerated in controlled clinical trials involving 1969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient.

Hypertension

In clinical trials in patients with hypertension treated with ZESTRIL, discontinuation of therapy due to clinical adverse experiences occurred in 5.7% of patients. The overall frequency of adverse experiences could not be related to total daily dosage within the recommended therapeutic dosage range.

For adverse experiences occurring in greater than 1% of patients with hypertension treated with ZESTRIL or ZESTRIL plus hydrochlorothiazide in controlled clinical trials, and more frequently with ZESTRIL and/or ZESTRIL plus hydrochlorothiazide than placebo, comparative incidence data are listed in the table below:

PERCENT OF PATIENTS IN CONTROLLED STUDIES

  ZESTRIL
(n=1349)
Incidence (discontinuation)
ZESTRIL/ Hydrochlorothiazide
(n=629)
Incidence (discontinuation)
PLACEBO
(n=207)
Incidence (discontinuation)
Body as amm  
  Fatigue 2.5 (0.3) 4.0 (0.5) 1.0 (0.0)
  Asthenia 1.3 (0.5) 2.1 (0.2) 1.0 (0.0)
  Orthostatic Effects 1.2 (0.0) 3.5 (0.2) 1.0 (0.0)
Cardiovascular
  Nasal Congestion 0.4 (0.1) 1.3 (0.1) 0.0 (0.0)
  Influenza 0.3 (0.1) 1.1 (0.1) 0.0 (0.0)
Skin
  Rash 1.3 (0.4) 1.6 (0.2) 0.5 (0.5)
Urogenital
  Impotence 1.0 (0.4) 1.6 (0.5) 0.0 (0.0)

Chest pain and back pain were also seen, but were more common on placebo than ZESTRIL.

Heart Failure

In patients with heart failure treated with ZESTRIL for up to four years, discontinuation of therapy due to clinical adverse experiences occurred in 11.0% of patients. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with ZESTRIL for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.

The following table lists those adverse experiences which occurred in greater than 1% of patients with heart failure treated with ZESTRIL or placebo for up to 12 weeks in controlled clinical trials, and more frequently on ZESTRIL than placebo.

Controlled Trials

  ZESTRIL
(n=407)
Incidence (discontinuation) 12 weeks
Placebo
(n=155)
Incidence (discontinuation) 12 weeks
Body as a Whole
  Chest Pain 3.4 (0.2) 1.3 (0.0)
  Abdominal Pain 2.2 (0.7) 1.9 (0.0)
Cardiovascular
  Hypotension 4.4 (1.7) 0.6 (0.6)
Digestive
  Diarrhea 3.7 (0.5) 1.9 (0.0)
Nervous/Psychiatric
  Dizziness 11.8 (1.2) 4.5 (1.3)
  Headache 4.4 (0.2) 3.9 (0.0)
Respiratory
  Upper Respiratory Infection 1.5 (0.0) 1.3 (0.0)
Skin
  Rash 1.7 (0.5) 0.6 (0.6)

Also observed at > 1% with ZESTRIL but more frequent or as frequent on placebo than ZESTRIL in controlled trials were asthenia, angina pectoris, nausea, dyspnea, cough, and pruritus.

Worsening of heart failure, anorexia, increased salivation, muscle cramps, back pain, myalgia, depression, chest sound abnormalities, and pulmonary edema were also seen in controlled clinical trials, but were more common on placebo than ZESTRIL.

In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse events were not different between the low and high groups, either in total number of discontinuation (17-18%) or in rare specific events ( < 1%). The following adverse events, mostly related to ACE inhibition, were reported more commonly in the high dose group:

% of patients Events High Dose
(N=1568)
Low Dose
(N=1596)
Dizziness 18.9 12.1
Hypotension 10.8 6.7
Creatinine increased 9.9 7.0
Hyperkalemia 6.4 3.5
NPN1 increased 9.2 6.5
Syncope 7.0 5.1
1 NPN = non-protein nitrogen

Acute Myocardial Infarction

In the GISSI-3 trial, in patients treated with ZESTRIL for six weeks following acute myocardial infarction, discontinuation of therapy occurred in 17.6% of patients.

Patients treated with ZESTRIL had a significantly higher incidence of hypotension and renal dysfunction compared with patients not taking ZESTRIL.

In the GISSI-3 trial, hypotension (9.7%), renal dysfunction (2.0%), cough (0.5%), post infarction angina (0.3%), skin rash and generalized edema (0.01%), and angioedema (0.01%) resulted in withdrawal of treatment. In elderly patients treated with ZESTRIL, discontinuation due to renal dysfunction was 4.2%.

Other clinical adverse experiences occurring in 0.3% to 1.0% of patients with hypertension or heart failure treated with ZESTRIL in controlled clinical trials and rarer, serious, possibly drug-related events reported in uncontrolled studies or marketing experience are listed below, and within each category are in order of decreasing severity:

Body as a Whole: Anaphylactoid reactions (See WARNINGS, Anaphylactoid and Possibly Related Reactions), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise.

Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients (See WARNINGS, Hypotension); pulmonary embolism and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia and premature ventricular contractions), palpitations, transient ischemic attacks, paroxysmal nocturnal dyspnea, orthostatic hypotension, decreased blood pressure, peripheral edema, vasculitis.

Digestive: Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (See WARNINGS, Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth.

Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.

Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion.

Metabolic: Weight loss, dehydration, fluid overload, gout, weight gain.

Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported in post-marketing experience (See DRUG INTERACTIONS).

Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, lumbago.

Nervous System/Psychiatric: Stroke, ataxia, memory impairment, tremor, peripheral neuropathy (e.g., dysesthesia), spasm, paresthesia, confusion, insomnia, somnolence, hypersomnia, irritability, nervousness ,mood alterations (including depressive symptoms) and hallucinations.

Respiratory System: Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, bronchitis, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea.

Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, psoriasis. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson Syndrome; causal relationship has not been established.

Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance.

Urogenital System: Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction (See PRECAUTIONS and DOSAGE AND ADMINISTRATION), pyelonephritis, dysuria, urinary tract infection, breast pain.

Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia and leukocytosis. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.

Angioedema: Angioedema has been reported in patients receiving ZESTRIL with an incidence higher in Black than in non-Black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with ZESTRIL should be discontinued and appropriate therapy instituted immediately (See WARNINGS).

In rare cases, intestinal angioedema has been reported in post marketing experience.

Hypotension: In hypertensive patients, hypotension occurred in 1.2% and syncope occurred in 0.1% of patients with an incidence higher in Black than in non-Black patients. Hypotension or syncope was a cause of discontinuation of therapy in 0.5% of hypertensive patients. In patients with heart failure, hypotension occurred in 5.3% and syncope occurred in 1.8% of patients. These adverse experiences were possibly dose-related (see above data from ATLAS Trial) and caused discontinuation of therapy in 1.8% of these patients in the symptomatic trials. In patients treated with ZESTRIL for six weeks after acute myocardial infarction, hypotension (systolic blood pressure ≤ 100 mmHg) resulted in discontinuation of therapy in 9.7% of the patients (See WARNINGS).

Cough: See PRECAUTIONS, Cough

Pediatric Patients: No relevant differences between the adverse experience profile for pediatric patients and that previously reported for adult patients were identified.

Clinical Laboratory Test Findings

Serum Electrolytes: Hyperkalemia (See PRECAUTIONS), hyponatremia.

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2.0% of patients with essential hypertension treated with ZESTRIL alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis (See PRECAUTIONS). Reversible minor increases in blood urea nitrogen and serum creatinine were observed in approximately 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with ZESTRIL but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia. Hemolytic anemia has been reported; a causal relationship to lisinopril cannot be excluded.

Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred (See WARNINGS, Hepatic Failure).

In hypertensive patients, 2.0% discontinued therapy due to laboratory adverse experiences, principally elevations in blood urea nitrogen (0.6%), serum creatinine (0.5%) and serum potassium (0.4%).

In the heart failure trials, 3.4% of patients discontinued therapy due to laboratory adverse experiences; 1.8% due to elevations in blood urea nitrogen and/or creatinine and 0.6% due to elevations in serum potassium.

In the myocardial infarction trial, 2.0% of patients receiving ZESTRIL discontinued therapy due to renal dysfunction (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration); less than 1.0% of patients discontinued therapy due to other laboratory adverse experiences: 0.1% with hyperkalemia and less than 0.1% with hepatic enzyme alterations.

Read the entire FDA prescribing information for Zestril (Lisinopril) »

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Zestril - User Reviews

Zestril User Reviews

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Here is a collection of user reviews for the medication Zestril sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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