Metoprololside effects
metoprolol tartrate 12.5 MG Oral Tablet
Adverse reactions
The following adverse reactions are described elsewhere in labeling: Worsening Ischemia with Abrupt Discontinuation Worsening heart failure. Worsening atrioventricular (AV) block. Most common adverse reactions in the setting of treatment of myocardial infarction are hypotension and bradycardia. To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical
Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Myocardial Infarction In a randomized comparison of LOPRESSOR and placebo in the setting of acute MI the following adverse reactions were reported: Adverse Reaction LOPRESSOR N=698 % Placebo N=697 % Hypotension (systolic BP < 90 mm Hg) 27.4% 23.2% Bradycardia (heart rate < 40 beats/min) 15.9% 6.7% Second- or third-degree heart block 4.7% 4.7% First-degree heart block (P-R ≥ 0.26 sec) 5.3% 1.9% Heart failure 27.5% 29.6%
6.2 Post-Marketing
Experience The following adverse reactions have been reported during post-approval use of LOPRESSOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased cognitive performance.
Cardiovascular: Worsening AV block.
Hematologic: Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura.
Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm and respiratory distress.
Laboratory Findings: Increase in blood triglycerides, elevated transaminase and decrease in high-density lipoprotein (HDL)
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 26, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
LOPRESSOR is contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.
Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. Cardiogenic shock or decompensated heart failure. Known hypersensitivity to product components.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 26, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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