Lisinopril and Hydrochlorothiazide Side Effects
Please note - some side effects for Lisinopril and Hydrochlorothiazide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Lisinopril and Hydrochlorothiazide Side Effects - for the Professional
Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide has been evaluated for safety in 930 patients, including 100 patients treated for 50 weeks or more.
In clinical trials with Lisinopril and Hydrochlorothiazide no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.
The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of Lisinopril and Hydrochlorothiazide were: dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%) and orthostatic effects (3.2%), all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature, but see WARNINGS regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4% of patients principally because of dizziness, cough, fatigue and muscle cramps.
Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below.
|Percent of Patients in Controlled Studies|
|Lisinopril and Hydrochlorothiazide (n = 930) Incidence (discontinuation)||
Placebo (n = 207) Incidence
|Orthostatic effects||3.2 (0.1)||1|
|Upper respiratory infection||2.2 (0)||0|
|Muscle cramps||2 (0.4)||0.5|
Clinical adverse experiences occurring in 0.3% to 1% of patients in controlled trials and rarer, serious, possibly drug-related events reported in marketing experience are listed below:
Body as a Whole
Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection
Palpitation, orthostatic hypotension
Gastrointestinal cramps, dry mouth, constipation, heartburn
Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain
Decreased libido, vertigo, depression, somnolence
Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort
Flushing, pruritus, skin inflammation, diaphoresis, cutaneous pseudolymphoma
Blurred vision, tinnitus, otalgia
Urinary tract infection
Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported.
In rare cases, intestinal angioedema has been reported in postmarketing experience.
In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (1.4%), orthostatic hypotension (0.5%), other orthostatic effects (3.2%). In addition, syncope occurred in 0.8% of patients.
Clinical Laboratory Test Findings
Minor reversible increases in blood urea nitrogen and serum creatinine were observed in patients with essential hypertension treated with Lisinopril and Hydrochlorothiazide. More marked increases have also been reported and were more likely to occur in patients with renal artery stenosis.
Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.5 g% and 1.5 vol%, respectively) occurred frequently in hypertensive patients treated with Lisinopril and Hydrochlorothiazide but were rarely of clinical importance unless another cause of anemia coexisted. In clinical trials, 0.4% of patients discontinued therapy due to anemia.
In clinical trials, adverse reactions which occurred with lisinopril were also seen with Lisinopril and Hydrochlorothiazide. In addition, and since lisinopril has been marketed, the following adverse reactions have been reported with lisinopril and should be considered potential adverse reactions for Lisinopril and Hydrochlorothiazide:
Anaphylactoid reactions, malaise, edema, facial edema, pain, pelvic pain, flank pain, chills
Cardiac arrest, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high-risk patients, pulmonary embolism and infarction, worsening of heart failure, arrhythmias (including tachycardia, ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia, and premature ventricular contractions), angina pectoris, transient ischemic attacks, paroxysmal nocturnal dyspnea, decreased blood pressure, peripheral edema, vasculitis
Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice), gastritis, anorexia, flatulence, increased salivation
Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia, and thrombocytopenia have been reported in which a causal relationship to lisinopril cannot be excluded
Ataxia, memory impairment, tremor, insomnia, stroke, nervousness, confusion, peripheral neuropathy (e.g., paresthesia, dysesthesia), spasm, hypersomnia, irritability; mood alterations (including depressive symptoms)
Malignant lung neoplasms, hemoptysis, pulmonary edema, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngitis, rhinitis, rhinorrhea, chest sound abnormalities
Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, rare cases of other severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome (causal relationship has not been established)
Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction, pyelonephritis, dysuria, breast pain
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.
Anorexia, gastric irritation, cramping, jaundice (intrahepatic cholestatic jaundice), pancreatitis, sialoadenitis, constipation
Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia
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