Metoprolol succinate: adverse event reports filed with FDA

10,416

reports as suspect product

0.1% of all reports · about 463 a year

664

reports, 12 months to June 2026

761 in the 12 months before

65.4%

marked serious by the reporter

78.7% across the class

10.4%

record death among outcomes, as reported

1,081 reports · not verified by FDA

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 Metoprolol succinate reports recording the termmedian drug in beta-adrenergic blocker

1. Off label useused for a purpose or in a way not on the label8.4%870
2. Drug ineffectivethe medicine did not work as expected8%838
3. Dizzinesslight-headedness or unsteadiness7.3%760
4. Dyspnoeashortness of breath7.1%744
5. Fatiguetiredness5.8%606
6. Hypotensionlow blood pressure5.4%558
7. Hypertensionhigh blood pressure4.4%456
8. Nauseafeeling sick4.3%453
9. Blood pressure increaseda raised blood pressure reading4.3%445
10. Headachehead pain4%414
11. Bradycardiaslow heart rate3.9%402
12. Drug interactionan interaction between medicines3.9%402
13. Palpitationsawareness of the heartbeat3.8%394
14. Malaisegeneral feeling of being unwell3.6%380
15. Suspected suicide3.6%375
16. Toxicity to various agentspoisoning or toxic effect of one or more substances3.5%363
17. Astheniaweakness or lack of energy3.4%355
18. Heart rate increaseda fast heart rate reading3.2%335
19. Diarrhoealoose or frequent stools3.1%324
20. Product substitution issuea problem after switching products3.1%323
21. Chest painchest pain3%308
22. Myocardial infarctionheart attack2.9%304
23. Atrial fibrillationan irregular heart rhythm2.9%301
24. Falla fall2.9%298
25. Product use in unapproved indicationused for a purpose not on the label2.6%270
26. Syncopefainting2.4%245
27. Inappropriate schedule of product administrationthe product was taken at the wrong times2.3%244
28. Arrhythmia2.3%239
29. Product quality issuea problem with the product itself2.2%232
30. Weight decreasedweight loss2.2%230

Top 30 of 1,433 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 67.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 10,416 reports.

Drugs most often listed in the same reports

Other products listed in reports where Metoprolol succinate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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

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.

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 Metoprolol succinate as a suspect or interacting product; reports listing it only as a concomitant medication (52,657) 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.