Sinus bradycardia adverse event reports that record this term

Kind of term: MedDRA preferred term

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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 9,468 adverse event reports that record the MedDRA preferred term Sinus bradycardia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 458 reports in the 12 months to June 2026 and 517 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 1,029 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, 458 (under 0.1%) record this term. Reports for patients 75 and over were 20.6% 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.

Data version

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

Drugs in these reports

The table has the 143 drug pages with 25 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Sinus bradycardia name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	27
Acetaminophen		57
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	33
Alemtuzumab	CD52-directed cytolytic antibody	40
Alendronate sodium	Bisphosphonate	29
Allopurinol	Xanthine oxidase inhibitor	34
Alprazolam	Benzodiazepine	98
Amiodarone		149
Amiodarone hcl		59
Amiodarone hydrochloride	Antiarrhythmic	41
Amlodipine	Calcium channel blocker	281
Amlodipine besylate	Dihydropyridine calcium channel blocker	44
Apixaban	Factor Xa inhibitor	37
Aredia		44
Aricept	Cholinesterase inhibitor	43
Aripiprazole	Atypical antipsychotic	56
Aspirin	Nonsteroidal anti-inflammatory drug	64
Atenolol	beta-Adrenergic blocker	329
Atorvastatin		32
Avandia		43
Azithromycin	Macrolide antimicrobial	29
Baclofen	gamma-Aminobutyric acid-ergic agonist	101
Bevacizumab	Vascular endothelial growth factor inhibitor	34
Bisoprolol	beta-Adrenergic blocker	382
Bisoprolol fumarate	beta-Adrenergic blocker	154
Bromazepam		36
Bupropion	Aminoketone	27
Candesartan	Angiotensin 2 receptor blocker	34
Carbamazepine	Mood stabilizer	47
Carboplatin	Platinum-based drug	31
Carvedilol	alpha-Adrenergic blocker	188
Cisplatin	Platinum-based drug	47
Citalopram hydrobromide	Serotonin reuptake inhibitor	34
Clonazepam	Benzodiazepine	64
Clonidine	Central alpha-2 adrenergic agonist	134
Cocaine		32
Cordarone		130
Crizotinib	Kinase inhibitor	32
Cyclophosphamide	Alkylating drug	59
Cytarabine	Nucleoside metabolic inhibitor	41
Desloratadine	Histamine-1 receptor antagonist	31
Dexamethasone	Corticosteroid	119
Dexmedetomidine hydrochloride	Central alpha-2 adrenergic agonist	25
Diazepam	Benzodiazepine	102
Digoxin	Cardiac glycoside	307
Diltiazem		108
Diltiazem hcl		26
Diltiazem hydrochloride	Calcium channel blocker	41
Diphenhydramine	Histamine-1 receptor antagonist	25
Donepezil		151
Donepezil hydrochloride	Cholinesterase inhibitor	25
Doxazosin	alpha-Adrenergic blocker	33
Eliquis	Factor Xa inhibitor	45
Entresto	Angiotensin 2 receptor blocker	39
Epinephrine	Catecholamine	27
Escitalopram	Serotonin reuptake inhibitor	101
Etoposide	Topoisomerase inhibitor	37
Exelon	Cholinesterase inhibitor	26
Fentanyl	Opioid agonist	102
Flecainide		68
Fluorouracil	Nucleoside metabolic inhibitor	43
Fluoxetine	Serotonin reuptake inhibitor	131
Fosamax	Bisphosphonate	74
Furosemide	Loop diuretic	132
Gabapentin	Anti-epileptic agent	27
Gilenya	Sphingosine 1-phosphate receptor modulator	337
Guanfacine	Central alpha-2 adrenergic agonist	51
Haloperidol	Typical antipsychotic	46
Hydralazine		29
Hydrochlorothiazide	Thiazide diuretic	95
Hydroxychloroquine	Antimalarial	25
Ibuprofen	Nonsteroidal anti-inflammatory drug	49
Irbesartan	Angiotensin 2 receptor blocker	57
Ivabradine	Hyperpolarization-activated cyclic nucleotide-gated channel blocker	44
Kisqali	Kinase inhibitor	41
Lacosamide		72
Lamotrigine	Anti-epileptic agent	37
Lanoxin	Cardiac glycoside	26
Lasix	Loop diuretic	39
Lemtrada	CD52-directed cytolytic antibody	32
Levetiracetam		55
Lidocaine	Amide local anesthetic	60
Lisinopril	Angiotensin converting enzyme inhibitor	42
Lithium	Mood stabilizer	26
Lithium carbonate	Mood stabilizer	62
Lorazepam	Benzodiazepine	47
Lyrica		49
Melatonin		25
Metformin	Biguanide	74
Methadone	Opioid agonist	40
Methylprednisolone	Corticosteroid	74
Metoclopramide	Dopamine-2 receptor antagonist	32
Metoprolol	beta-Adrenergic blocker	264
Metoprolol succinate	beta-Adrenergic blocker	103
Metoprolol tartrate	beta-Adrenergic blocker	98
Midazolam	Benzodiazepine	28
Mirtazapine		53
Morphine	Opioid agonist	25
Nebivolol	beta-Adrenergic blocker	45
Nifedipine	Dihydropyridine calcium channel blocker	27
Nitroglycerin	Nitrate vasodilator	26
Olanzapine	Atypical antipsychotic	131
Omeprazole	Proton pump inhibitor	35
Ondansetron	Serotonin-3 receptor antagonist	49
Oxazepam	Benzodiazepine	31
Perindopril		33
Prazosin	alpha-Adrenergic blocker	29
Prednisolone	Corticosteroid	49
Prednisone	Corticosteroid	44
Pregabalin		78
Propafenone	Antiarrhythmic	40
Propofol	General anesthetic	71
Propranolol	beta-Adrenergic blocker	138
Propranolol hydrochloride	beta-Adrenergic blocker	56
Quetiapine	Atypical antipsychotic	121
Ramipril	Angiotensin converting enzyme inhibitor	107
Ranitidine	Histamine-2 receptor antagonist	34
Remdesivir	SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	64
Revlimid	Thalidomide analog	47
Risperdal	Atypical antipsychotic	66
Risperidone	Atypical antipsychotic	129
Rituximab	CD20-directed cytolytic antibody	76
Sacubitril valsartan		25
Sertraline	Serotonin reuptake inhibitor	74
Simvastatin	HMG-CoA reductase inhibitor	35
Sotalol	Antiarrhythmic	48
Spironolactone	Aldosterone antagonist	83
Tacrolimus	Calcineurin inhibitor immunosuppressant	28
Tenormin	beta-Adrenergic blocker	32
Thalomid		25
Tramadol		27
Trazodone		29
Valproate sodium	Anti-epileptic agent	33
Valsartan	Angiotensin 2 receptor blocker	36
Veklury	SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	63
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	47
Verapamil		105
Vimpat		31
Vioxx		231
Zoloft	Serotonin reuptake inhibitor	28
Zolpidem	gamma-Aminobutyric acid A receptor positive modulator	32
Zometa		69
Zopiclone		27

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 47 pharmacologic classes with 50 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Sinus bradycardia name, in order of name
Class	Reports with this term
Aldosterone antagonist	121
Alkylating drug	67
alpha-Adrenergic blocker	277
Amide local anesthetic	73
Angiotensin 2 receptor blocker	240
Angiotensin converting enzyme inhibitor	182
Anti-epileptic agent	152
Antiarrhythmic	212
Antimalarial	63
Atypical antipsychotic	664
Azole antifungal	55
Benzodiazepine	431
beta-Adrenergic blocker	1,672
Biguanide	99
Bisphosphonate	107
Calcium channel blocker	354
Cardiac glycoside	333
Catecholamine	53
CD20-directed cytolytic antibody	88
CD52-directed cytolytic antibody	72
Central alpha-2 adrenergic agonist	285
Cholinesterase inhibitor	119
Corticosteroid	383
Dihydropyridine calcium channel blocker	97
Factor Xa inhibitor	103
gamma-Aminobutyric acid-ergic agonist	104
General anesthetic	87
Histamine-1 receptor antagonist	72
HMG-CoA reductase inhibitor	82
Kinase inhibitor	190
Loop diuretic	194
Mood stabilizer	144
Nitrate vasodilator	57
Nonsteroidal anti-inflammatory drug	168
Nucleoside metabolic inhibitor	113
Opioid agonist	248
P2Y12 platelet inhibitor	54
Platinum-based drug	101
Programmed death Receptor-1 blocking antibody	50
Proton pump inhibitor	82
SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	127
Serotonin and norepinephrine reuptake inhibitor	86
Serotonin reuptake inhibitor	482
Serotonin-3 receptor antagonist	56
Sphingosine 1-phosphate receptor modulator	345
Thalidomide analog	77
Thiazide diuretic	95

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

Reports by month

Reports that record Sinus bradycardia, by month, five years to June 2026

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 Sinus bradycardia
Age	Reports	Share
Under 2	91	1%
2 to 11	194	2%
12 to 17	292	3.1%
18 to 44	1,525	16.1%
45 to 64	2,299	24.3%
65 to 74	1,467	15.5%
75 and over	1,955	20.6%
Age not given	1,645	17.4%

Sex of the patient in the reports that record Sinus bradycardia
Sex	Reports	Share
Female	4,576	48.3%
Male	4,076	43.1%
Unknown or not given	816	8.6%

Age and sex are as the report gives them. 40.4% 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

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Sinus bradycardia: adverse event reports that record this term. https://reportedreactions.com/reaction/sinus-bradycardia/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 Sinus bradycardia mean in an adverse event report?

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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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