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Prinivil

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Prinivil

Prinivil Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Prinivil (lisinopril) is a synthetic peptide derivative, is a long-acting angiotensin converting enzyme (ACE) inhibitor, used to treat hypertension, heart failure, and supportive treatment in patients that suffer a myocardial infarction (heart attack). Lisinopril is the generic name for the drug. Lisinopril is also found in combination with other drugs such as hydrochlorothiazide for hypertension treatment. Common side effects of Prinivil are headache, fatigue, diarrhea, and cough.

Prinivil is available in 5, 10 and 20 mg tablets for oral use. Hypertensive patients usually start with 10 mg once a day and are often increased to 20 mg. Patients with renal failure or are on diuretics start at lower doses such as 2.5 to 5 mg. Heart attack and heart failure patients also start out with low doses of 5 mg one per day. Prinivil is not recommended for use in children <6 years old or those that have a glomerular filtration rate <30 mL per min; pediatric doses are determined by weight. Prinivil and other ACE inhibitors should not be used in pregnant patients due to the possibility of fetal injury or death. Patients that become pregnant should immediately contact their doctors and stop Prinivil. Black patients have a higher incidence of head and neck angioedema (swelling under the skin).

Our Prinivil 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.

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.

Prinivil 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 less than usual or not at all;
  • swelling, rapid weight gain;
  • fever, chills, body aches, flu symptoms;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • psoriasis (raised, silvery flaking of the skin);
  • chest pain; or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

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 Prinivil (Lisinopril) »

What is Patient Information Overview?

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

Prinivil 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, 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.

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 Prinivil (Lisinopril)»

What is Prescribing information?

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

Prinivil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

PRINIVIL 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 PRINIVIL, discontinuation of therapy due to clinical adverse experiences occurred in 5.7 percent 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 one percent of patients with hypertension treated with PRINIVIL or PRINIVIL plus hydrochlorothiazide in controlled clinical trials and more frequently with PRINIVIL and/or PRINIVIL plus hydrochlorothiazide than placebo, comparative incidence data are listed in table 1 below:

Table 1 : Percent of Patients in Controlled Studies

  PRINIVIL
(n=1349) Incidence (discontinuatio n)
PRINIVIL/ Hydrochlorothiazi de
(n=629) Incidence (discontinuation)
Placebo
(n=207) Incidence (discontinuatio n)
Body As A Whole
  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
  Hypotension 1.2 (0.5) 1.6 (0.5) 0.5 (0.5)
Digestive
  Diarrhea 2.7 (0.2) 2.7 (0.3) 2.4 (0.0)
  Nausea 2.0 (0.4) 2.5 (0.2) 2.4 (0.0)
  Vomiting 1.1 (0.2) 1.4 (0.1) 0.5 (0.0)
  Dyspepsia 0.9 (0.0) 1.9 (0.0) 0.0 (0.0)
Musculoskeletal
  Muscle Cramps 0.5 (0.0) 2.9 (0.8) 0.5 (0.0)
Nervous/Psychiatric
  Headache 5.7 (0.2) 4.5 (0.5) 1.9 (0.0)
  Dizziness 5.4 (0.4) 9.2 (1.0) 1.9 (0.0)
  Paresthesia 0.8 (0.1) 2.1 (0.2) 0.0 (0.0)
  Decreased Libido 0.4 (0.1) 1.3 (0.1) 0.0 (0.0)
  Vertigo 0.2 (0.1) 1.1 (0.2) 0.0 (0.0)
Respiratory
  Cough 3.5 (0.7) 4.6 (0.8) 1.0 (0.0)
Upper Respiratory
  Infection 2.1 (0.1) 2.7 (0.1) 0.0 (0.0)
  Common Cold 1.1 (0.1) 1.3 (0.1) 0.0 (0.0)
  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 PRINIVIL.

Heart Failure

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

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

Table 2 : Controlled Trials

  PRINIVIL
(n=407) Incidence (discontinuation)
Placebo
(n=155) Incidence (discontinuation)
12 weeks 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 PRINIVIL but more frequent or as frequent on placebo than PRINIVIL 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 PRINIVIL.

Acute Myocardial Infarction

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

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

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

Other clinical adverse experiences occurring in 0.3 to 1.0 percent of patients with hypertension or heart failure treated with PRINIVIL in controlled 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, syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolic: Weight loss, dehydration, fluid overload, gout, weight gain. Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported (see PRECAUTIONS: 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, and nervousness.

Respiratory System: Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, asthma, pleural effusion, pneumonia, 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. Other severe skin reactions (including toxic epidermal necrolysis, Stevens-Johnson syndrome and cutaneous pseudolymphoma) have been reported rarely; causal relationship has not been established.

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

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 PRINIVIL (0.1%) 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 PRINIVIL should be discontinued and appropriate therapy instituted immediately. In rare cases, intestinal angioedema has been reported with angiotensin converting enzyme inhibitors including lisinopril. (See WARNINGS.)

Hypotension: In hypertensive patients, hypotension occurred in 1.2 percent and syncope occurred in 0.1 percent of patients. Hypotension or syncope was a cause for discontinuation of therapy in 0.5 percent of hypertensive patients. In patients with heart failure, hypotension occurred in 5.3 percent and syncope occurred in 1.8 percent of patients. These adverse experiences were causes for discontinuation of therapy in 1.8 percent of these patients. In patients treated with PRINIVIL for six weeks after acute myocardial infarction, hypotension (systolic blood pressure ≤ 100 mmHg) resulted in discontinuation of therapy in 9.7 percent of the patients. (See WARNINGS.)

Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

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 percent of patients with essential hypertension treated with PRINIVIL 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 percent 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 percent and 1.3 vol percent, respectively) occurred frequently in patients treated with PRINIVIL but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1 percent 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 percent discontinued therapy due to laboratory adverse experiences, principally elevations in blood urea nitrogen (0.6 percent), serum creatinine (0.5 percent) and serum potassium (0.4 percent). In the heart failure trials, 3.4 percent of patients discontinued therapy due to laboratory adverse experiences, 1.8 percent due to elevations in blood urea nitrogen and/or creatinine and 0.6 percent due to elevations in serum potassium. In the myocardial infarction trial, 2.0 percent of patients receiving PRINIVIL 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 percent of patients discontinued therapy due to other laboratory adverse experiences: 0.1 percent with hyperkalemia and less than 0.1 percent with hepatic enzyme alterations.

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

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Prinivil - User Reviews

Prinivil User Reviews

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

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