Drugs › beta-Adrenergic blocker
Brand name · Metoprolol tartrate
Lopressor: adverse event reports filed with FDA
1,418 reports list it as a suspect or interacting product, 2004–2026. Class: beta-Adrenergic blocker.
- 1,418
- reports as suspect product
- 0% of all reports · about 63 a year
- 207
- reports, 12 months to June 2026
- 13 in the 12 months before
- 71.9%
- marked serious by the reporter
- 78.7% across the class
- 6.8%
- record death among outcomes, as reported
- 96 reports · not verified by FDA
1,418 adverse event reports received by FDA list the brand name Lopressor (metoprolol tartrate) as a suspect or interacting product, from January 2004 to June 2026. A further 19,003 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 207 reports listed it, up 1492% from 13 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 63 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the beta-Adrenergic blocker class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded dizziness (9.5%), drug ineffective (8.7%) and dyspnoea (8.3%). A report can list several reactions, so shares add to more than 100%; 439 different terms appear across these reports. Dizziness is recorded in 9.5% of these reports, a larger share than in the median beta-Adrenergic blocker drug (4.8%).
71.9% of the reports are marked serious by the reporter (78.7% across the class); 6.8% record death among the outcomes and 38.2% record hospitalisation, as reported. 46.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (19.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lopressor reports recording the termmedian drug in beta-adrenergic blocker
- Dizzinesslight-headedness or unsteadiness9.5%135
- Drug ineffectivethe medicine did not work as expected8.7%123
- Dyspnoeashortness of breath8.3%118
- Hypotensionlow blood pressure7.8%111
- Fatiguetiredness7.5%107
- Hypertensionhigh blood pressure7.3%104
- Nauseafeeling sick5.6%79
- Drug hypersensitivityan allergic-type reaction to a medicine5.4%77
- Malaisegeneral feeling of being unwell5.3%75
- Bradycardiaslow heart rate5.2%74
- Headachehead pain5%71
- Astheniaweakness or lack of energy4.9%69
- Syncopefainting4.7%66
- Coughcough4.5%64
- Atrial fibrillationan irregular heart rhythm4%57
- Blood pressure increaseda raised blood pressure reading3.9%55
- Palpitationsawareness of the heartbeat3.7%52
- Diarrhoealoose or frequent stools3.6%51
- Heart rate decreased3.3%47
- Chest painchest pain3.2%46
- Rashskin rash3.1%44
- Arthralgiajoint pain2.8%39
- Falla fall2.7%38
- Drug interactionan interaction between medicines2.5%35
- Painpain, site not specified2.5%35
- Abdominal pain upperupper stomach pain2.3%32
- Heart rate increaseda fast heart rate reading2.3%32
- Renal impairmentreduced kidney function2.3%32
- Acute kidney injurysudden loss of kidney function2.2%31
- Weight decreasedweight loss2.2%31
Top 30 of 439 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 22 drugs in the beta-adrenergic blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 148,208 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 70.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypertension | 267 | 18.8% |
| Atrial fibrillation | 32 | 2.3% |
| Blood pressure abnormal | 17 | 1.2% |
| Blood pressure | 8 | 0.6% |
| Heart rate increased | 6 | 0.4% |
| Migraine | 6 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,418 reports.
In context
| Measure | Lopressor | beta-Adrenergic blocker | All reports |
|---|---|---|---|
| Reports as suspect product | 1,418 | 148,208 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 207 | — | 1,332,454 |
| Marked serious | 71.9% | 78.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 68 | 131 | 91 |
| Hospitalisation recorded, per 1,000 reports | 382 | 387 | 213 |
| Consumer-filed share | 46.8% | 26.8% | 45.8% |
| Top term, share of reports | Dizziness 9.5% | median 4.8% | 2.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the beta-adrenergic blocker class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Metoprolol | generic | 27,410 | 1,520 | 88.2% |
| Bisoprolol | brand | 22,881 | 1,454 | 99.1% |
| Atenolol | generic | 17,022 | 444 | 84.9% |
| Propranolol | generic | 13,733 | 1,177 | 87.1% |
| Metoprolol succinate | generic | 10,416 | 664 | 65.4% |
| Metoprolol tartrate | generic | 9,103 | 557 | 72.4% |
| Bisoprolol fumarate | generic | 8,292 | 546 | 98.2% |
| Propranolol hydrochloride | generic | 6,102 | 484 | 71.9% |
| Timolol | generic | 4,818 | 97 | 20.7% |
| Hemangeol | brand | 4,383 | 441 | 5.4% |
| Nebivolol | generic | 4,211 | 386 | 93.9% |
| Toprol Xl | brand | 3,341 | 35 | 44.5% |
| Labetalol | generic | 2,960 | 192 | 88.7% |
| Bystolic | brand | 2,841 | 21 | 31.1% |
| Timolol maleate | generic | 2,743 | 120 | 29.9% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lopressor reports
How many adverse event reports has FDA received for Lopressor?
1,418 reports list Lopressor as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 207 of them arrived in the latest 12 months. Another 19,003 list it only as a concomitant medication.
What reactions are recorded in Lopressor reports?
dizziness (9.5%), drug ineffective (8.7%), dyspnoea (8.3%), hypotension (7.8%) and fatigue (7.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lopressor was responsible.
How serious are the reports?
71.9% are marked serious by the reporter. Among the outcomes recorded, 6.8% of reports include death and 38.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (46.8%), other health professional (19.2%) and physician (18.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lopressor rising?
207 reports in the 12 months to June 2026, up 1492% from 13 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lopressor was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lopressor?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lopressor as a suspect or interacting product; reports listing it only as a concomitant medication (19,003) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.