This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: 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 TOPROL-XL, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients 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 TOPROL-XL therapy abruptly even in patients treated only for hypertension (5.1). WARNING: ISCHEMIC HEART DISEASE See full prescribing information for complete boxed warning. Following abrupt cessation of therapy with beta-blocking agents, exacerbations of angina pectoris and myocardial infarction have occurred. Warn patients against interruption...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
TOPROL-XL, metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) • Angina Pectoris. (1.2) • Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3) 1.1 Hypertension TOPROL-XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advic...
is contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. • Known hypersensitivity to product components. (4) • Severe bradycardia. (4) • Heart block greater than first degree. (4) • Cardiogenic shock. (4) • Decompensated cardiac failure. (4) • Sick sinus syndrome without a pacemaker. (4)
• Heart Failure: Worsening cardiac failure may occur. (5.2) • Bronchospastic Disease: Avoid beta blockers. (5.3) • Pheochromocytoma: If required, first initiate therapy with an alpha blocker. (5.4) • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery because it has been associated with bradycardia, hypotension, stroke and death. Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5.5 , 6.1 ) • Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia. (5.6) • Patients with Hepatic Impairment: (5.7) • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. (5.8) • Anaphylactic Reactions: Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (5.9) • Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (5.10) • Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomit...
The following adverse reactions are described elsewhere in labeling: • Worsening angina or myocardial infarction [see Warnings and Precautions (5) ]. • Worsening heart failure [see Warnings and Precautions (5) ]. • Worsening AV block [see Contraindications (4) ]. Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aralez Pharmaceuticals US Inc. at 1-866-207-6592 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension and Angina: Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea...
Source: FDA SPL label for TOPROL XL (Aphena Pharma Solutions - Tennessee, LLC), effective 20180220. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 30,026 | 27,436 | 23,457 | 21,358 | 20,411 | 19,770 | 20,397 | 10,238 |
1,037 reports blaming this drug for every million Medicare prescriptions filled, which is 0.4× the typical drug on this site. (50,010 reports in 2024–2026, against 48,208,301 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 05/2024 | Class II | Rubicon Research Private Limited | Presence of Foreign Substance: metal in tablet |
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 12/2021 | Class II | Rubicon Research Private Limited | Complaint received of foreign matter (metal) embedded in tablet. |
| 09/2021 | Class II | Aurobindo Pharma USA Inc. | Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. |
| 10/2018 | Class III | Baxter Healthcare Corporation | Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. |
| 04/2018 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets. |
| 05/2014 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. |
| 12/2013 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specification; 12-Month stability interval. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Metoprolol Succinate | 32,213,092 | $14 |
| Metoprolol Tartrate | 15,912,137 | $7 |
| Kapspargo Sprinkle | 44,309 | $60 |
| Toprol XL | 37,862 | $132 |
| Lopressor | 901 | $344 |
2 drugs in the same class grade a letter or more higher than metoprolol on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.