Prinivil

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Prinivil (lisinopril) 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). Prinivil is available in generic form. Lisinopril is also found in combination with other drugs such as hydrochlorothiazide for hypertension treatment. Common side effects of Prinivil include:

• Cough,
• Headache,
• Dizziness,
• Depressed mood,
• Drowsiness,
• Nausea,
• Upset stomach,
• Vomiting,
• Diarrhea, and
• Mild itching or skin rash.

Prinivil is available in doses of 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 may interact with other blood pressure medications, gold injections, lithium, potassium supplements, salt substitutes that contain potassium, oral insulin or diabetes medications, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), or diuretics (water pills). Tell your doctor all medications and supplements you use. 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.

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 Tablets for Oral Administration)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

The following adverse reactions (events 2% greater on PRINIVIL than on placebo) were observed with PRINIVIL vs placebo: headache (5.7% vs 1.9%), dizziness (5.4% vs 1.9%), cough (3.5% vs 1.0%).

Heart Failure

In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with PRINIVIL for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.

The following adverse reactions (events 2% greater on PRINIVIL than on placebo) were observed with PRINIVIL vs placebo: hypotension (4.4% vs 0.6%), chest pain (3.4% vs 1.3%).

In the ATLAS trial [see Clinical Studies] in heart failure patients, withdrawals for adverse reactions were similar in the low- and high-dose groups. The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group:

Table 1: Dose-related Adverse Drug Reactions : ATLAS trial

Acute Myocardial Infarction

Patients in the GISSI-3 study, treated with PRINIVIL, had a higher incidence of hypotension (9.0% vs 3.7%) and renal dysfunction (2.4% vs 1.1%) compared with patients not taking PRINIVIL.

Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with PRINIVIL in controlled clinical trials and do not appear in other sections of labeling are listed below:

Body as a whole: Fatigue, asthenia, orthostatic effects.

Digestive: Pancreatitis, constipation, flatulence, dry mouth, diarrhea.

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

Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion.

Metabolic: Gout

Skin: Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens - Johnson syndrome, and pruritus.

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

Urogenital: Impotence

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

Clinical Laboratory Test Findings

Serum Potassium: In clinical trials hyperkalemia (serum potassium > 5.7 mEq/L) occurred in 2.2% and 4.8% of PRINIVIL-treated patients with hypertension and heart failure, respectively [see WARNINGS AND PRECAUTIONS].

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with PRINIVIL alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis [see WARNINGS AND PRECAUTIONS]. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Patients with acute myocardial infarction in the GISSI-3 trial treated with PRINIVIL had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction in-hospital and at 6 weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration).

Hemoglobin and Hematocrit: Small decreases in hemoglobin (mean 0.4 mg/dL) and hematocrit (mean 1.3%) occurred frequently in patients treated with PRINIVIL but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, fewer than 0.1% of patients discontinued therapy for anemia.

Liver Enzymes

Rarely, elevations of liver enzymes and/or serum bilirubin have occurred [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of lisinopril that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Other Reactions Include

Metabolism and Nutrition Disorders

Hyponatremia [see WARNINGS AND PRECAUTIONS], cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin [see DRUG INTERACTIONS]

Nervous System and Psychiatric Disorders

Mood alterations (including depressive symptoms), mental confusion

Read the entire FDA prescribing information for Prinivil (Lisinopril Tablets for Oral Administration)

Read the Prinivil User Reviews »

© Prinivil Patient Information is supplied by Cerner Multum, Inc. and Prinivil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.