Metoprolol Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Metoprolol: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.
- What Metoprolol Is Prescribed For, and Where Metoprolol Side Effects Come From
- Warnings on the Metoprolol Label
- Warnings Beyond the Common Metoprolol Side Effects
- Metoprolol Side Effects Listed on the FDA Label
- Reported Metoprolol Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Metoprolol Recall History
- Is Metoprolol the Subject of Litigation?
- If You Are Worried About Metoprolol Side Effects
- Frequently Asked Questions
- Official Sources
- Related Guides
Before you read on. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.
What Metoprolol Is Prescribed For, and Where Metoprolol Side Effects Come From
According to the FDA label, etoprolol succinate extended-release tablets, are a beta-adrenergic blocker 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, to reduce the risk of cardiovascular mortality and heartfailure hospitalizations in patients with heart failure ( 1.3 ) 1.1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. […]
Two separate official sources describe metoprolol side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.
| Active ingredient | Metoprolol Succinate |
| Brand names on this label | METOPROLOL SUCCINATE |
| How it is given | oral |
| Boxed warning | See the label for this product |
| Recall records | 23 |
| Label last updated | 2022-11-01 |
Warnings on the Metoprolol Label
The FDA prescribing label carries the full set of warnings and precautions for Metoprolol. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.
You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.
Warnings Beyond the Common Metoprolol Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Metoprolol it covers: abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) Bronchospastic Disease: Avoid beta blockers. ( 5.3 ) Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. ( 5.4 ) PheochromocytomaInitiate therapy with an alpha blocker. ( 5.5 ) Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery.
Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5. 6 , 6.1 ) Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia. ( 5. 7 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.8 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. ( 5. 9 ) Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine metoprolol side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.
Metoprolol Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: he 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 Hetero Labs Limited at 1-866-495-1995 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. […]
Trial data is the most reliable source for how common metoprolol side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.
Reported Metoprolol Side Effects in the FDA Database
Reported metoprolol side effects — and what these numbers do not mean
The FDA’s adverse event database holds 347,921 reports mentioning Metoprolol, of which 238,988 were classified as serious.
Read those numbers carefully. An adverse event report means somebody told the FDA that something happened to a person taking this medicine. It is not a finding that the medicine caused it. Reports are submitted voluntarily by patients, families, doctors and manufacturers; nobody verifies them; and the same event can be reported more than once.
Report volume tracks how many people take a drug, how new it is, and how much attention it is getting. A widely prescribed medicine will always show more reports than a rarely used one, and reports rise sharply when a drug is in the news or in litigation. A large number here does not mean a drug is dangerous, and a small number does not mean it is safe.
| Most frequently reported | Reports |
|---|---|
| Fatigue | 22,947 |
| Dyspnoea | 19,850 |
| Diarrhoea | 19,495 |
| Nausea | 19,310 |
| Dizziness | 16,393 |
| Death | 13,943 |
| Asthenia | 13,259 |
| Headache | 13,052 |
Source: FDA Adverse Event Reporting System (FAERS), retrieved July 2026. Non-clinical reporting categories such as “off label use” have been excluded from the list above because they describe how a drug was used, not something that happened to a patient.
Who the Label Says Should Take Extra Care
Contraindications. The label states that Metoprolol should not be used in certain situations: etoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, 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. Known hypersensitivity to product components. ( 4 ) Severe bradycardia : Greater than first degree heart block, or sick sinus syndrome without a pacemaker. […]
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Interactions with other medicines. Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. ( 7.1 ) CYP2D6 Inhibitors are likely to increase metoprolol concentration. ( 7.2 ) Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. ( 7.3 ) 7.1 Catecholamine Depleting Drugs Catecholamine depleting drugs (eg., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. […]
Older adults. 8.5 Geriatric Use Clinical studies of metoprolol succinate extended-release tablets in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. […]
Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.
Metoprolol Recall History
The FDA enforcement database records 23 recall entries involving Metoprolol products (22 Class II, 1 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.
The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.
| Date | Class | Recalling firm | Reason |
|---|---|---|---|
| 2026-05-20 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications |
| 2026-03-11 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 2026-03-11 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 2026-03-11 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| 2026-03-11 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.
Is Metoprolol the Subject of Litigation?
We are not tracking consolidated federal litigation over Metoprolol. It is a widely prescribed medicine, and the information on this page is drawn from the FDA label and public safety data rather than from any legal claim.
If You Are Worried About Metoprolol Side Effects
Concern about metoprolol side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.
Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its metoprolol side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.
You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.
Frequently Asked Questions
What are the most commonly reported metoprolol side effects?
In FDA reports, the most frequently mentioned are fatigue, dyspnoea, diarrhoea. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.
Has Metoprolol been recalled?
There are 23 recall records for Metoprolol products, the most recent dated 2026-05-20. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.
Does Metoprolol have a boxed warning?
A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.
Do the FDA report numbers tell me how common these metoprolol side effects are?
No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.
Where can I check metoprolol side effects for the exact product I have?
DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.
Official Sources
- DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
- FDA Adverse Event Reporting System dashboard — the public report data summarised above
- FDA recalls and safety alerts — current recall notices
- FDA MedWatch — how to report a side effect yourself
Related Guides
Medical and legal disclaimer. This page summarises publicly available FDA data about Metoprolol and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Metoprolol caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.
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FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.