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Prinivil

Prinivil (Lisinopril Tablets for Oral Administration) side effects drug center

 

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CONSUMER

SIDE EFFECTS

 

Prinivil Side Effects Center

What Is Prinivil?

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.

What Are Side Effects of Prinivil?

Common side effects of Prinivil include:

Dosage for Prinivil

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.

What Drugs, Substances, or Supplements Interact with Prinivil?

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 During Pregnancy and Breastfeeding

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).

Additional Information

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

 

Prinivil Consumer Information

Get emergency medical help if you have 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 if you are African-American.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • fever, sore throat;
  • high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache, dizziness;
  • cough; or
  • chest pain.

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)

 

Prinivil Professional Information

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

High Dose
(n=1568)		 Low Dose
(n=1596)
Dizziness 19% 12%
Hypotension 11% 7%
Creatinine increased 10% 7%
Hyperkalemia 6% 4%
Syncope 7% 5%

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

DRUG INTERACTIONS

Diuretics

Initiation of PRINIVIL in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with PRINIVIL can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with PRINIVIL. If this is not possible, reduce the starting dose of PRINIVIL [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

PRINIVIL attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or other drugs that may increase serum potassium can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient's serum potassium frequently.

Antidiabetics

Concomitant administration of PRINIVIL and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.

Dual Blockade Of The Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.

In general, avoid combined use of RAS inhibitors. Monitor blood pressure, renal function and electrolytes in patients on PRINIVIL and other agents that affect the RAS.

Do not coadminister aliskiren with PRINIVIL in patients with diabetes. Avoid use of aliskiren with PRINIVIL in patients with renal impairment (GFR <60 ml/min).

Lithium

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including PRINIVIL.

Mammalian Target Of Rapamycin (mTOR) Inhibitors

Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema [see WARNINGS AND PRECAUTIONS].

Neprilysin Inhibitors

Patients taking a concomitant neprilysin inhibitor (e.g., sacubitril) may be at increased risk for angioedema [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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

&Copy; 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.