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- Does Zestoretic (lisinopril and hydrochlorothiazide) cause side effects?
- What are the important side effects of Zestoretic (lisinopril and hydrochlorothiazide)?
- Zestoretic (lisinopril and hydrochlorothiazide) side effects list for healthcare professionals
- What drugs interact with Zestoretic (lisinopril and hydrochlorothiazide)?
Does Zestoretic (lisinopril and hydrochlorothiazide) cause side effects?
Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Lisinopril is an ACE inhibitor and works by relaxing blood vessels so that blood can flow more easily. Hydrochlorothiazide is a diuretic that causes you to make more urine, which helps the body get rid of extra salt and water.
Common side effects of Zestoretic include
Serious side effects of Zestoretic include
- high potassium blood levels (muscle weakness, slow/irregular heartbeat),
- signs of infection (fever, chills, persistent sore throat),
- change in the amount of urine (not including the normal increase in urine when first starting this drug),
- decrease in vision,
- eye pain,
- loss of too much body water (dehydration) and salt/minerals (extreme thirst,
- very dry mouth,
- muscle cramps/weakness,
- fast/slow/irregular heartbeat,
- decreased urination, and rarely,
- serious (possibly fatal) liver problems (dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin).
Drug interactions of Zestoretic include aliskiren, lithium, drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone).
Check the labels on all medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase blood pressure or worsen heart failure.
Zestoretic is not recommended for use during pregnancy due to the risk for harm to a fetus. Consult your doctor for more details.
What are the important side effects of Zestoretic (lisinopril and hydrochlorothiazide)?
Common side effects of Zestoretic include
Serious side effects of Zestoretic include
Zestoretic (lisinopril and hydrochlorothiazide) side effects list for healthcare professionals
Zestoretic has been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more.
In clinical trials with Zestoretic 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 prescribing information 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)
|Upper Respiratory Infection||2.2||(0.0)||0.0|
Clinical adverse experiences occurring in 0.3% to 1.0% of patients in controlled trials and rarer, serious, possibly drug-related events reported in marketing experience are listed below:
Cardiovascular: Palpitation, orthostatic hypotension.
Skin: Flushing, pruritus, skin inflammation, diaphoresis, cutaneous pseudolymphoma.
Urogenital: Urinary tract infection.
Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported.
In rare cases, intestinal angioedema has been reported in post marketing experience.
- hypotension (1.4%),
- orthostatic hypotension (0.5%),
- other orthostatic effects (3.2%).
- In addition syncope occurred in 0.8% of patients.
Cough: See prescribing information.
Clinical Laboratory Test Findings
See prescribing information.
Creatinine, Blood Urea Nitrogen
Minor reversible increases in blood urea nitrogen and serum creatinine were observed in patients with essential hypertension treated with Zestoretic. More marked increases have also been reported and were more likely to occur in patients with renal artery stenosis.
Serum Uric Acid, Glucose, Magnesium, Cholesterol, Triglycerides And Calcium
See prescribing information.
Hemoglobin And Hematocrit
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 Zestoretic but were rarely of clinical importance unless another cause of anemia coexisted. In clinical trials, 0.4% of patients discontinued therapy due to anemia.
Liver Function Tests
Other adverse reactions that have been reported with the individual components are listed below:
In clinical trials adverse reactions which occurred with lisinopril were also seen with Zestoretic. 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 Zestoretic:
Cardiovascular: 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;
Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion;
Nervous System/Psychiatric: Ataxia, memory impairment, tremor, insomnia, stroke, nervousness, confusion, peripheral neuropathy (e.g., paresthesia, dysesthesia), spasm, hypersomnia, irritability; mood alterations (including depressive symptoms); hallucinations;
Respiratory: 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;
Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, psoriasis, rare cases of other severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson Syndrome (causal relationship has not been established);
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.
Body as a Whole: Weakness;
Hematologic: Leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia;
Musculoskeletal: Muscle spasm;
Nervous System/Psychiatric: Restlessness;
Renal: Renal failure, renal dysfunction, interstitial nephritis;
Special Senses: Xanthopsia;
Hypersensitivity: Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions.
What drugs interact with Zestoretic (lisinopril and hydrochlorothiazide)?
Hypotension -Patients On Diuretic Therapy
Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril.
If it is necessary to continue the diuretic, initiate therapy with lisinopril at a dose of 5 mg daily, and provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour. When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed.
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, co-administration 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 aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albuminto-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 state 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, closely monitor blood pressure, renal function and electrolytes in patients on Zestoretic and other agents that affect the RAS.
Do not co-administer aliskiren with Zestoretic in patients with diabetes. Avoid use of aliskiren with Zestoretic in patients with renal impairment (GFR < 60 ml/min).
Lisinopril has been used concomitantly with nitrates and/or digoxin without evidence of clinically significant adverse interactions. No meaningful clinically important pharmacokinetic interactions occurred when lisinopril was used concomitantly with propranolol, digoxin, or hydrochlorothiazide. The presence of food in the stomach does not alter the bioavailability of lisinopril.
Agents Increasing Serum Potassium
Lisinopril attenuates potassium loss caused by thiazide-type diuretics. Use of lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated, because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.
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. It is recommended that serum lithium levels be monitored frequently if lisinopril is administered concomitantly with lithium.
mTOR (mammalian Target Of Rapamycin) Inhibitors
Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema.
When administered concurrently the following drugs may interact with thiazide diuretics.
Antidiabetic drugs (oral agents and insulin) -dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs -additive effect or potentiation.
Cholestyramine and colestipol resins -Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.
Pressor amines (e.g., norepinephrine) -possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) -possible increased responsiveness to the muscle relaxant.
Lithium -should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with Zestoretic.
Non-Steroidal Anti-inflammatory Drugs -In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Zestoretic and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of Zestoretic is obtained.
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 Zestoretic.
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Related Disease Conditions
High Blood Pressure (Hypertension)
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
High Blood Pressure Treatment (Natural Home Remedies, Diet, Medications)
High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
High Blood Pressure Symptoms
Most people with high blood pressure have no signs or symptoms, even if blood pressure readings reach dangerously high levels. In some patients, symptoms may include fatigue, headaches, dizziness, confusion, sweating, chest pain and vision problems.
What Is High Blood Pressure (Hypertension)?
High blood pressure or hypertension is when the blood pressure readings consistently range from 140 or higher for systolic or 90 or higher for diastolic. Blood pressure readings above 180/120 mmHg are dangerously high and require immediate medical attention.
Treatment & Diagnosis
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Medications & Supplements
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.