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adverse reactions
ADVERSE REACTIONS Lisinopril has been found to be generally well tolerated in controlled clinical trials involving 1,969 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 lisinopril, 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 lisinopril or lisinopril plus hydrochlorothiazide in controlled clinical trials, and more frequently with lisinopril and/or lisinopril plus hydrochlorothiazide than placebo, comparative incidence data are listed in the table below: PERCENT OF PATIENTS IN CONTROLLED STUDIES Lisinopril (n = 1349) Incidence (discontinuation) Lisinopril/Hydrochlorothiazide (n = 629) Incidence (discontinuation) Placebo (n = 207) Incidence (discontinuation) Body As A Whole Fatigue2.5 (0.3)4 (0.5)1 (0)Asthenia1.3 (0.5)2.1 (0.2)1 (0)Orthostatic effects1.2 (0)3.5 (0.2)1 (0) Cardiovascular Hypotension1.2 (0.5)1.6 (0.5)0.5 (0.5) Digestive Diarrhea2.7 (0.2)2.7 (0.3)2.4 (0)Nausea2 (0.4)2.5 (0.2)2.4 (0)Vomiting1.1 (0.2)1.4 (0.1)0.5 (0)Dyspepsia0.9 (0)1.9 (0)0 (0) Musculoskeletal Muscle cramps0.5 (0)2.9 (0.8)0.5 (0) Nervous/Psychiatric Headache5.7 (0.2)4.5 (0.5)1.9 (0)Dizziness5.4 (0.4)9.2 (1)1.9 (0)Paresthesia0.8 (0.1)2.1 (0.2)0 (0)Decreased libido0.4 (0.1)1.3 (0.1)0 (0)Vertigo0.2 (0.1)1.1 (0.2)0 (0) Respiratory Cough3.5 (0.7)4.6 (0.8)1 (0)Upper respiratoryinfection2.1 (0.1)2.7 (0.1)0 (0)Common cold1.1 (0.1)1.3 (0.1)0 (0)Nasal congestion0.4 (0.1)1.3 (0.1)0 (0)Influenza0.3 (0.1)1.1 (0.1)0 (0) Skin Rash1.3 (0.4)1.6 (0.2)0.5 (0.5) Urogenital Impotence1 (0.4)1.6 (0.5)0 (0) Chest pain and back pain were also seen, but were more common on placebo than lisinopril. Heart Failure In patients with heart failure treated with lisinopril for up to four years, discontinuation of therapy due to clinical adverse experiences occurred in 11% of patients. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril 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 lisinopril or placebo for up to 12 weeks in controlled clinical trials, and more frequently on lisinopril than placebo. CONTROLLED TRIALS Lisinopril (n = 407) Incidence (discontinuation) 12 weeks Placebo (n = 155) Incidence(discontinuation) 12 weeks Body As A Whole Chest pain3.4 (0.2)1.3 (0)Abdominal pain2.2 (0.7)1.9 (0) Cardiovascular Hypotension4.4 (1.7)0.6 (0.6) Digestive Diarrhea3.7 (0.5)1.9 (0) Nervous/Psychiatric Dizziness11.8 (1.2)4.5 (1.3)Headache4.4 (0.2)3.9 (0) Respiratory Upper respiratoryInfection1.5 (0)1.3 (0) Skin Rash1.7 (0.5)0.6 (0.6) Also observed at > 1% with lisinopril but more frequent or as frequent on placebo than lisinopril 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 lisinopril. 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 to 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: * *NPN = non-protein nitrogen % of Patients Events High Dose (n = 1568) Low Dose (n = 1596) Dizziness Hypotension Creatinine increased Hyperkalemia NPN* *increased Syncope18.9 10.8 9.9 6.4 9.2 712.1 6.7 7 3.5 6.5 5.1 Acute Myocardial Infarction In the GISSI-3 trial, in patients treated with lisinopril for six weeks following acute myocardial infarction, discontinuation of therapy occurred in 17.6% of patients. Patients treated with lisinopril had a significantly higher incidence of hypotension and renal dysfunction compared with patients not taking lisinopril. In the GISSI-3 trial, hypotension (9.7%), renal dysfunction (2%), 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 lisinopril, discontinuation due to renal dysfunction was 4.2%. Other clinical adverse experiences occurring in 0.3% to 1% of patients with hypertension or heart failure treated with lisinopril 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 embolsim and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibillation, 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 antidiurectic 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 postmarketing experience (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, nervousness and mood alterations (including depressive symptoms). 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, flusing, diaphoresis, cutaneous pseudolymphoma, psoriasis. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson syndrome; causual 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 PRECAUTIONSand 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 lisinopril 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 lisinopril should be discontinued and appropriate therapy instituted immediately (see WARNINGS). In rare cases, intestinal angioedema has been reported in postmarketing 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 lisinopril for six weeks after acute myocardial infarction, hypotension (systolic blood pressure100 mmHg) resulted in discontinuation of therapy in 9.7% of the patients (see WARNINGS). Cough 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 p> 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 essential hypertension treated with lisinopril 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) occured frequently in patients treated with lisinopril 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 casual 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% 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 faulure trials, 3.4% of patiens discontinued therapy due to laboratory adverse experience; 1.8% due to elevations in blood ura nitrogen and/or creatinine and 0.6 due to elevations in serum potassium. In the myocardial infarction trial, 2% of patients receiving lisinopril discontinued thereapy 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% of patients discontinued therapy due to other laboratory adverse experiences: 0.1% with hyperkalemia and less than 0.1% with hepatic enzyme alterations.