Boxed Warning Section
Ischemic Heart Disease:
Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol therapy abruptly even in patients treated only for hypertension.
Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration.
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patients clinical condition allows (see
DOSAGE AND ADMINISTRATION,
WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION).
Published Studies Related to Metoprolol
Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS ? A randomized controlled trial. [2011.12]
Abstract Aim. To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in hypertension...
Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure-a randomized study. [2011.10.15]
ABSTRACT: BACKGROUND: Carvedilol has been shown to be superior to metoprolol tartrate to improve clinical outcomes in patients with heart failure (HF), yet the mechanisms responsible for these differences remain unclear. We examined if there were differences in endothelial function, insulin stimulated endothelial function, 24 hour ambulatory blood pressure and heart rate during treatment with carvedilol, metoprolol tartrate and metoprolol succinate in patients with HF... CONCLUSION: Endothelial function remained unchanged when switching the beta blocker treatment from carvedilol to either metoprolol tartrate or metoprolol succinate in this study, where blood pressure and heart rate also remained unchanged in patients with mild HF. TRIAL REGISTRATION: Current Controlled Trials NCT00497003.
beta-Blockers in patients with intermittent claudication and arterial hypertension: results from the nebivolol or metoprolol in arterial occlusive disease trial. [2011.08]
The use of beta-receptor blockers in peripheral arterial disease is controversial for their impact on vasomotor tone... In the direct comparison, there was no significant difference between nebivolol and metoprolol.
Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. [2011.06]
The aim of this study was to investigate the effects of the vasodilating beta-blocker nebivolol and the cardioselective beta-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness... This proof-of-principle study provides evidence to suggest that beta-blockers with vasodilating properties may offer advantages over conventional beta-blockers in antihypertensive therapy; however, this remains to be tested in a larger trial.
The effect of nebivolol versus metoprolol succinate extended release on asymmetric dimethylarginine in hypertension. [2011.05]
This study sought to determine if metoprolol succinate ER (MET), and nebivolol (NEB), a beta1-AR with increased bioavailability of nitric oxide (NO), would have differing effects on plasma asymmetric dimethylarginine concentration in hypertensives. It was hypothesized that NEB, a beta1-AR antagonist and beta3-AR agonist with NO-releasing properties, and MET, only a beta1-AR antagonist, would have different effects on plasma asymmetric dimethylarginine (ADMA) concentration...
Clinical Trials Related to Metoprolol
Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life [Completed]
Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is
a recognized and common side effect of beta-blockers that can have significant effects on
quality of life. Worse, many people taking a beta-blocker for years are not even aware of
the reduction of energy with which they are living.
A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of
hypertension, appears to be far less associated with fatigue than are most currently
available beta-blockers. The purpose of this study is to compare nebivolol with the current
best-selling beta-blocker, metoprolol, and determine whether there is a significant
difference in side effects including fatigue, reduced exertion tolerance, and reduced
quality of life.
In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4
weeks at a lower dose, and 4 weeks ata higher dose. All dosages are FDA-approved for
treatment of hypertension. Subjects and investigators will not know which drug is being
administered until completion of the study. Subjects will undergo a treadmill stress test
and will complete fatigue and quality of life questionnaires after each 4 weeks of
treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be
performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible
measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then
be compared. If nebivolol is found to cause significantly less fatigue, it would be of
substantial importance to the many millions of people who are on life-long beta-blocker
therapy, and are living with reduced energy.
Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function [Recruiting]
Beta-blockers (BB) are an important treatment for high blood pressure and heart disease.
However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits
successful use of this class of medications. Sexual side effects often result in drug
discontinuation, compromising therapy goals. The investigators are conducting the study to
determine if nebivolol, a newer beta blocker that is selective for receptors in the heart
and causes vasodilation in the body causes fewer sexual side effects, or even improves
sexual function, compared with metoprolol succinate.
Open-Labeled PK-PD Studies of Metoprolol ER [Not yet recruiting]
Recently, the quality of generic metoprolol extended-release (ER) (Toprol XL,
Activas,Wockhardt) products has been called into question with reports of inconsistent
effects when switching from the brand name product to a generic formulation. Problems with
how the body processes these drugs could have serious and widespread consequences given the
high frequency of metoprolol ER use in the management of various cardiovascular disorders,
including high blood pressure, coronary heart disease, heart failure, and cardiac
arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead
to variability in the way the body breaks down the drug (pharmacokinetics) and clinical
response to generic versus name brand metoprolol ER formulation. Investigators will study
the brand name and generic metoprolol ER formulations in subjects with high blood pressure
to compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses
of each product.
The study objective is to provide information on how the body breaks down generic and brand
name metoprolol ER products (pharmacokinetics) and how the body responds to generic and
brand name metoprolol ER products (pharmacodynamics) to better understand if generic
metoprolol ER products are as good as the brand name product.
Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults [Completed]
The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg
twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in
The secondary objective is to assess the safety and tolerability of a single oral dose of
metoprolol 50 mg when administered alone and in combination with repeated oral doses of
eliglustat 150 mg BID in healthy adults.
Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects [Recruiting]
Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and
probably is responsible for CDN $250 million in health care spending each year. It is
associated with decreased quality of life, trauma, loss of employment, and limitations in
daily activities. The most common cause is vasovagal syncope.
This occurs in people of all ages, and is a lifelong predilection. While the median number
of faints in the population is 2, those who come to the investigators care have a median
10-15 lifetime spells, and have an increased frequency in the year before presentation.
Vasovagal syncope is due to abrupt hypotension and transient bradycardia, which cause
cerebral hypoperfusion. The pathophysiology may be either failure of venous return or
progressive vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic
stimulation might be involved early in the reflex cascade. There is no known medical
treatment for frequent fainting. The investigators performed the pivotal CIHR-funded
randomized trials that showed that neither permanent pacing, beta blockers, nor
fludrocortisone help the majority of patients.
However 3 observational studies suggested that beta blockers prevent syncope in older
subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, - stratified
analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis
showed a benefit from metoprolol in these patients, with a hazard ratio of 0. 52 (CI 0. 27 to
1. 01), and an age-specific response to beta blockers (p = 0. 007). These results suggest the
need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope
in older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and
neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92%
agreed to participate in such a trial. Separately, this study emerged as the first choice
for syncope randomized trials after consultation with Canadian and international experts.
Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate
to severely frequent vasovagal syncope will better suppress syncope recurrences than
Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled,
randomized clinical trial.
Patients will be enrolled during a recruitment period of 4 years and followed for a fixed
period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of
vasovagal syncope based on a quantitative diagnostic score. They will be randomized to
receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will
be made according to treating physician discretion to optimize tolerance and compliance
while maximizing dose. The primary outcome measure will be the time to the first recurrence
of syncope (after a 2 week dose titration wash-in period) over the 1-year observation
period. The primary analysis will be performed on an intention-to-treat basis. Secondary
analyses will include an on-treatment analysis, as well as analyses comparing syncope and
presyncope frequency, number needed to treat, quality of life, impact of syncope on daily
living, and cost from the perspective of the publicly funded health care system. The
investigators will enroll 248 patients to have an 85% power to detect a reduction (p<0. 05)
in the primary outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative
risk reduction. This sample size also allows for a 11% rate of subject dropout with loss to
follow-up before a syncopal event. The University of Calgary Syncope Clinic has a
well-functioning clinical trial apparatus that successfully completed the randomized,
multicenter Prevention of Syncope Trials (POST1: metoprolol for vasovagal syncope; POST2:
fludrocortisone for vasovagal syncope) and SIRCAT (Statin-Induced Reduction of
Cardiomyopathy Trial). Enrolment is underway in the CIHR-funded POST3 (pacing versus loop
recorders in syncope patients with bifascicular block) and POST4 (midodrine for vasovagal
syncope). Study centres that were highly productive in POST1-4 have agreed to participate.
The investigators therefore will have ample syncope enrolling centres.
Relevance: This study will provide evidence to inform the use of metoprolol in the treatment
of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the
lack of any other conventional medical therapy the investigators expect it to have rapid
impact on care.
Reports of Suspected Metoprolol Side Effects
Completed Suicide (26),
Cardiogenic Shock (22),
Cardiac Arrest (14),
Intentional Overdose (11),
Hypoglycaemia (8), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 5 ratings/reviews, Metoprolol has an overall score of 8.40. The effectiveness score is 8.40 and the side effect score is 8.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Metoprolol review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || tachycardia|
|Dosage & duration:|| || 50mg taken once per day for the period of on-going since 2006|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I have very few racing heart episodes since I have been on this medication.|
|Side effects:|| || The side effect has been a slight decrease in my metabolism. I gained 5 pounds within 3 weeks of starting the medication. But, the benefit greatly outweighs this minor side effect. A purposeful increase in daily exercise has helped to prevent further weight gain.|
|Comments:|| || I take one 50 mg pill once per day with food or milk.|
Metoprolol review by 56 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || hypertension|
|Dosage & duration:|| || 100 mg taken 1 x daily for the period of 3 years|
|Other conditions:|| || none|
|Other drugs taken:|| || Lotrel|
|Benefits:|| || My blood pressure readings have improved.|
|Side effects:|| || There were no side effects. I have tolerated the drug very well. |
|Comments:|| || I have taken this drug daily for three years for hypertension in combination with Lotrel. My blood pressure readings have dropped from 160/120 to 120/80. The drug has been effective and well-tolerated.|
Metoprolol review by 36 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || high blood pressure|
|Dosage & duration:|| || 50 MG taken once daily for the period of 1 year and counting|
|Other conditions:|| || diabetes sarcoidosis|
|Other drugs taken:|| || none|
|Benefits:|| || no headaches (had salt sensitive migraines)|
|Side effects:|| || dizzy, vomiting. my bp is sometimes too low especially after exercise but I am not having headaches as long or often|
|Comments:|| || once daily, bp check every 3 months, bp checks at home, watch diet (no added salt), lose weight. I have to go to dr. every so often for liver/kidney/glucose check too. |
Page last updated: 2011-12-09