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| __NOTOC__
| | #REDIRECT [[Lisinopril#Adverse Reactions]] |
| {{Lisinopril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Adverse Reactions==
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| Lisinopril have 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.
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| ====Hypertension====
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| 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.
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| 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:
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| [[Chest pain]] and back pain were also seen, but were more common on placebo than lisinopril.
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| ====Heart Failure====
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| In patients with [[heart failure]] treated with lisinopril 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 lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
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| 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.
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| 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]].
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| 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.
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| ====Acute Myocardial Infarction====
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| 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.
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| Patients treated with lisinopril had a significantly higher incidence of [[hypotension]] and [[renal dysfunction]] compared with patients not taking lisinopril.
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| 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 lisinopril, discontinuation due to renal dysfunction was 4.2%.
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| Other clinical adverse experiences occurring in 0.3% to 1.0% 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:
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| ====Body as a Whole====
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| Anaphylactoid reactions , [[syncope]], [[orthostatic effects]], chest discomfort, pain, [[pelvic pain]], [[flank pain]], edema, [[facial edema]], virus infection, [[fever]], [[chills]], [[malaise]].
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| ====Cardiovascular====
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| [[Cardiac arrest]]; [[myocardial infarction]] or [[cerebrovascular accident]] possibly secondary to excessive [[hypotension]] in high risk patients; [[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]].
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| ====Digestive====
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| [[Pancreatitis]], [[hepatitis]] (hepatocellular or [[cholestatic jaundice]]) , [[vomiting]], [[gastritis]], [[dyspepsia]], [[heartburn]], [[gastrointestinal cramps]], [[constipation]], [[flatulence]], dry mouth.
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| ====Hematologic====
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| Rare cases of [[bone marrow depression]], [[hemolytic anemia]], [[leukopenia]]/[[neutropenia]], and [[thrombocytopenia]].
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| ====Endocrine====
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| [[Diabetes mellitus]].
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| ====Metabolic====
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| [[Weight loss]], [[dehydration]], fluid overload, [[gout]], weight gain.
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| ====Musculoskeletal====
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| [[Arthritis]], [[arthralgia]], neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, [[lumbago]].
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| ====Nervous System/Psychiatric====
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| [[Stroke]], [[ataxia]], [[memory impairment]], [[tremor]], [[peripheral neuropathy]] (e.g., [[dysesthesia]]), spasm, [[paresthesia]], [[confusion]], [[insomnia]], [[somnolence]], [[hypersomnia]], irritability and [[nervousness]].
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| ====Respiratory System====
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| 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]].
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| ====Skin====
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| [[Urticaria]], [[alopecia]], [[herpes zoster]], [[photosensitivity], skin lesions, skin infections, [[pemphigus]], [[erythema], [[flushing], [[diaphoresis]]. Other severe skin reactions have been reported rarely, including [[toxic epidermal necrolysis]] and [[Stevens-Johnson syndrome]]; causal relationship has not been established.
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| ====Special Senses====
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| Visual loss, [[diplopia]], blurred vision, [[tinnitus]], [[photophobia]], taste alteration.
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| ====Urogenital System====
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| [[Acute renal failure]], [[oliguria]], [[anuria]], [[uremia], progressive [[azotemia]], renal dysfunction , pyelonephritis, dysuria, urinary tract infection, [[breast pain]].
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| ====Miscellaneous====
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| 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.
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| ====Angioedema====
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| [[Angioedema]] has been reported in patients receiving lisinopril (0.1%). 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.
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| ====Hypotension====
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| In hypertensive patients, [[hypotension]] occurred in 1.2% and syncope occurred in 0.1% of 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 causes for discontinuation of therapy in 1.8% of these patients. In patients treated with lisinopril for six weeks after [[acute myocardial infarction]], hypotension (systolic blood pressure ≤100 mmHg) resulted in discontinuation of therapy in 9.7% of the patients.
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| ====Fetal/Neonatal Morbidity and Mortality====
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| See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
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| ====Cough====
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| See PRECAUTIONS - Cough
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| ====Clinical Laboratory Test Findings====
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| Serum Electrolytes: [[Hyperkalemia]] (see PRECAUTIONS), [[hyponatremia]].
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| ====Creatinine, Blood Urea Nitrogen====
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| 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 lisinopril alone. Increases were more common in patients receiving concomitant diuretics and in patients with [[renal artery stenosis]]. 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.
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| ====Hemoglobin and Hematocrit====
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| Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred 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]].
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| ====Liver Function Tests====
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| Rarely, elevations of [[liver enzymes]] and/or [[serum bilirubin]] have occurred.
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| 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%).
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| 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 lisinopril 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LISINOPRIL (LISINOPRIL) TABLET [LEK PHARMACEUTICALS] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=27ccb2f4-abf8-4825-9b05-0bb367b4ac07 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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