Reported Reactions

Adverse event reports that FDA received

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Bradycardia adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
slow heart rate

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 52,223 adverse event reports that record the MedDRA preferred term Bradycardia. In plain words, the term means: slow heart rate. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,302 reports in the 12 months to June 2026 and 2,243 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 316 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 2,302 (0.2%) record this term. Reports for patients 75 and over were 23.8% of the reports that record this term and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Plain meaning

Slow heart rate. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 71 drug pages with 250 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports with the term Bradycardia name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen473
AldactoneAldosterone antagonist314
AlemtuzumabCD52-directed cytolytic antibody260
AlprazolamBenzodiazepine438
Amiodarone891
AmlodipineCalcium channel blocker1,548
Amlodipine besylateDihydropyridine calcium channel blocker321
AspirinNonsteroidal anti-inflammatory drug385
Atenololbeta-Adrenergic blocker1,499
Atorvastatin340
Baclofengamma-Aminobutyric acid-ergic agonist438
Bisoprololbeta-Adrenergic blocker2,078
Bisoprolol fumaratebeta-Adrenergic blocker633
BupropionAminoketone289
Carvedilolalpha-Adrenergic blocker986
CitalopramSerotonin reuptake inhibitor347
ClonazepamBenzodiazepine456
ClonidineCentral alpha-2 adrenergic agonist482
Cordarone519
CyclophosphamideAlkylating drug316
DexamethasoneCorticosteroid483
DiazepamBenzodiazepine419
DigoxinCardiac glycoside1,785
Diltiazem661
Diltiazem hydrochlorideCalcium channel blocker260
Donepezil550
EntrestoAngiotensin 2 receptor blocker286
EpinephrineCatecholamine316
EscitalopramSerotonin reuptake inhibitor310
FentanylOpioid agonist610
Flecainide265
FluoxetineSerotonin reuptake inhibitor351
FurosemideLoop diuretic1,014
GabapentinAnti-epileptic agent409
GilenyaSphingosine 1-phosphate receptor modulator1,073
HydrochlorothiazideThiazide diuretic317
IbuprofenNonsteroidal anti-inflammatory drug346
LanoxinCardiac glycoside250
LasixLoop diuretic263
Levetiracetam325
LidocaineAmide local anesthetic340
LisinoprilAngiotensin converting enzyme inhibitor454
LorazepamBenzodiazepine504
Lyrica293
MetforminBiguanide634
MethotrexateFolate analog metabolic inhibitor257
Metoprololbeta-Adrenergic blocker1,758
Metoprolol succinatebeta-Adrenergic blocker402
Metoprolol tartratebeta-Adrenergic blocker628
MorphineOpioid agonist279
Nebivololbeta-Adrenergic blocker310
NifedipineDihydropyridine calcium channel blocker256
OlanzapineAtypical antipsychotic380
PantoprazoleProton pump inhibitor291
Paracetamol300
Pregabalin342
PropofolGeneral anesthetic618
Propranololbeta-Adrenergic blocker883
Propranolol hydrochloridebeta-Adrenergic blocker330
QuetiapineAtypical antipsychotic395
RamiprilAngiotensin converting enzyme inhibitor887
RemdesivirSARS-CoV-2 nucleotide analog RNA polymerase inhibitor445
RevlimidThalidomide analog272
RisperidoneAtypical antipsychotic324
RituximabCD20-directed cytolytic antibody301
SertralineSerotonin reuptake inhibitor294
SpironolactoneAldosterone antagonist499
ValsartanAngiotensin 2 receptor blocker250
VenlafaxineSerotonin and norepinephrine reuptake inhibitor285
Verapamil601
Vioxx323

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 52 pharmacologic classes with 250 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Bradycardia name, in order of name
ClassReports with this term
Aldosterone antagonist996
Alkylating drug434
alpha-Adrenergic blocker1,469
Amide local anesthetic769
Aminoketone410
Angiotensin 2 receptor blocker1,871
Angiotensin converting enzyme inhibitor1,635
Anti-epileptic agent1,319
Antiarrhythmic1,004
Anticholinergic344
Atypical antipsychotic2,312
Azole antifungal256
Benzodiazepine2,729
beta-Adrenergic blocker9,179
Biguanide1,006
Calcineurin inhibitor immunosuppressant291
Calcium channel blocker2,222
Cardiac glycoside2,035
Catecholamine575
CD20-directed cytolytic antibody541
CD52-directed cytolytic antibody404
Central alpha-2 adrenergic agonist1,372
Cholinesterase inhibitor668
Corticosteroid1,554
Dihydropyridine calcium channel blocker681
Endothelin receptor antagonist262
Factor Xa inhibitor820
Fluoroquinolone antibacterial290
Folate analog metabolic inhibitor301
gamma-Aminobutyric acid-ergic agonist523
General anesthetic1,079
Histamine-1 receptor antagonist326
HMG-CoA reductase inhibitor799
Insulin analog393
Kinase inhibitor933
Loop diuretic1,527
Mood stabilizer560
Nondepolarizing neuromuscular blocker328
Nonsteroidal anti-inflammatory drug1,173
Nucleoside metabolic inhibitor516
Opioid agonist2,037
Osmotic laxative362
P2Y12 platelet inhibitor542
Platinum-based drug482
Proton pump inhibitor885
SARS-CoV-2 nucleotide analog RNA polymerase inhibitor635
Serotonin and norepinephrine reuptake inhibitor610
Serotonin reuptake inhibitor2,150
Sphingosine 1-phosphate receptor modulator1,226
Thalidomide analog424
Thiazide diuretic347
Tumor necrosis factor blocker521

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Bradycardia, by month, five years to June 2026
025050020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Bradycardia
AgeReportsShareShare as a bar
Under 21,1632.2%
2 to 111,1072.1%
12 to 171,2982.5%
18 to 447,02613.5%
45 to 6410,32019.8%
65 to 747,78914.9%
75 and over12,43823.8%
Age not given11,08221.2%
Sex of the patient in the reports that record Bradycardia
SexReportsShareShare as a bar
Female23,36944.7%
Male23,28144.6%
Unknown or not given5,57310.7%

Age and sex are as the report gives them. 38.2% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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Reported Reactions. Bradycardia: adverse event reports that record this term. https://reportedreactions.com/reaction/bradycardia/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Bradycardia mean in an adverse event report?

In plain words: slow heart rate. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .