Reported Reactions

Adverse event reports that FDA received

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Arrhythmia 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 . 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 46,691 adverse event reports that record the MedDRA preferred term Arrhythmia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,045 reports in the 12 months to June 2026 and 2,056 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 356 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, 2,045 (0.2%) record this term. Reports for male patients were 40.5% of the reports that record this term and 34.6% 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 147 drug pages with 100 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 Arrhythmia name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic163
Acetaminophen195
Aclasta122
ActemraInterleukin-6 receptor antagonist117
AlprazolamBenzodiazepine115
Amiodarone256
Amitriptyline145
AmlodipineCalcium channel blocker341
ApixabanFactor Xa inhibitor337
AripiprazoleAtypical antipsychotic108
AspirinNonsteroidal anti-inflammatory drug211
Atenololbeta-Adrenergic blocker150
Atorvastatin282
Avandamet140
Avandia916
AvastinVascular endothelial growth factor inhibitor121
Avelox102
AvonexInterferon beta133
BevacizumabVascular endothelial growth factor inhibitor104
Bextra216
Bisoprololbeta-Adrenergic blocker409
Bisoprolol fumaratebeta-Adrenergic blocker113
BupropionAminoketone155
CapecitabineNucleoside metabolic inhibitor151
CarboplatinPlatinum-based drug177
Carvedilolalpha-Adrenergic blocker149
CelebrexNonsteroidal anti-inflammatory drug237
CiprofloxacinFluoroquinolone antibacterial325
CisplatinPlatinum-based drug139
CitalopramSerotonin reuptake inhibitor214
ClarithromycinMacrolide antimicrobial114
ClonazepamBenzodiazepine156
ClopidogrelP2Y12 platelet inhibitor107
ClozapineAtypical antipsychotic212
ClozarilAtypical antipsychotic113
Cordarone109
CosentyxInterleukin-17A antagonist150
CrestorHMG-CoA reductase inhibitor164
CyclophosphamideAlkylating drug404
Cymbalta138
Darvocet494
Darvon489
DexamethasoneCorticosteroid315
DiazepamBenzodiazepine139
DigoxinCardiac glycoside470
DiovanAngiotensin 2 receptor blocker369
Diovan HCTAngiotensin 2 receptor blocker118
DoxorubicinAnthracycline topoisomerase inhibitor242
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor114
EliquisFactor Xa inhibitor415
EnbrelTumor necrosis factor blocker429
EntrestoAngiotensin 2 receptor blocker750
EscitalopramSerotonin reuptake inhibitor171
EtoposideTopoisomerase inhibitor126
Euthyrox105
ExelonCholinesterase inhibitor129
ExforgeAngiotensin 2 receptor blocker112
FentanylOpioid agonist115
Flecainide134
FluorouracilNucleoside metabolic inhibitor196
FluoxetineSerotonin reuptake inhibitor147
ForteoParathyroid hormone analog378
FosamaxBisphosphonate169
FurosemideLoop diuretic282
GabapentinAnti-epileptic agent126
GilenyaSphingosine 1-phosphate receptor modulator241
HerceptinHER2/neu receptor antagonist108
Humira723
HydrochlorothiazideThiazide diuretic108
IbuprofenNonsteroidal anti-inflammatory drug208
ImbruvicaKinase inhibitor376
InfliximabTumor necrosis factor blocker108
KisqaliKinase inhibitor199
LamotrigineAnti-epileptic agent114
LetrozoleAromatase inhibitor105
LevofloxacinFluoroquinolone antibacterial182
LipitorHMG-CoA reductase inhibitor205
LisinoprilAngiotensin converting enzyme inhibitor127
LorazepamBenzodiazepine160
Lyrica267
MetforminBiguanide210
MethotrexateFolate analog metabolic inhibitor346
Metoprololbeta-Adrenergic blocker381
Metoprolol succinatebeta-Adrenergic blocker239
Mirtazapine155
MultaqAntiarrhythmic120
Mycophenolate mofetilAntimetabolite immunosuppressant134
NexiumProton pump inhibitor151
Novothyrox352
OlanzapineAtypical antipsychotic353
OmeprazoleProton pump inhibitor266
OndansetronSerotonin-3 receptor antagonist104
OpsumitEndothelin receptor antagonist178
OxaliplatinPlatinum-based drug170
OxyContinOpioid agonist125
PaclitaxelMicrotubule inhibitor143
PantoprazoleProton pump inhibitor226
PlavixP2Y12 platelet inhibitor143
PradaxaDirect thrombin inhibitor182
PrednisoloneCorticosteroid255
PrednisoneCorticosteroid421
Pregabalin157
ProliaRANK ligand inhibitor182
Propacet 100298
PropofolGeneral anesthetic129
Propoxyphene Hcl292
Propoxyphene Hcl and Acetaminophen382
Propoxyphene Napsylate W/Acetaminophen321
QuetiapineAtypical antipsychotic329
Quetiapine fumarateAtypical antipsychotic121
RamiprilAngiotensin converting enzyme inhibitor323
RebifInterferon beta106
RemicadeTumor necrosis factor blocker210
RemodulinProstacycline vasodilator107
RepathaPCSK9 inhibitor114
RevlimidThalidomide analog501
RisperdalAtypical antipsychotic171
RisperidoneAtypical antipsychotic162
RituximabCD20-directed cytolytic antibody494
RivaroxabanFactor Xa inhibitor106
RosuvastatinHMG-CoA reductase inhibitor164
Sandostatin LAR Depot109
SeroquelAtypical antipsychotic182
SertralineSerotonin reuptake inhibitor149
SimponiTumor necrosis factor blocker106
SimvastatinHMG-CoA reductase inhibitor158
SpironolactoneAldosterone antagonist181
SymbicortCorticosteroid131
Synthroidl-Thyroxine111
TasignaKinase inhibitor144
TikosynAntiarrhythmic185
Tiotropium bromideAnticholinergic108
TorsemideLoop diuretic112
TracleerEndothelin receptor antagonist157
Tramadol121
ValsartanAngiotensin 2 receptor blocker195
VedolizumabIntegrin receptor antagonist104
VelcadeProteasome inhibitor137
VenlafaxineSerotonin and norepinephrine reuptake inhibitor128
Vincristine241
Vioxx1,579
XareltoFactor Xa inhibitor274
XeljanzJanus kinase inhibitor158
XolairAnti-IgE168
XyremCentral nervous system depressant106
Zometa144
ZyprexaAtypical antipsychotic126

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 48 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 Arrhythmia name, in order of name
ClassReports with this term
Aldosterone antagonist310
Alkylating drug527
alpha-Adrenergic blocker311
Aminoketone256
Angiotensin 2 receptor blocker2,053
Angiotensin converting enzyme inhibitor556
Anthracycline topoisomerase inhibitor411
Anti-epileptic agent640
Antiarrhythmic681
Anticholinergic293
Atypical antipsychotic2,352
Benzodiazepine966
beta-Adrenergic blocker1,619
Biguanide327
Bisphosphonate330
Calcium channel blocker452
Cardiac glycoside490
CD20-directed cytolytic antibody731
Central nervous system stimulant303
Corticosteroid1,631
Endothelin receptor antagonist531
Factor Xa inhibitor1,153
Fluoroquinolone antibacterial581
Folate analog metabolic inhibitor454
GLP-1 receptor agonist340
Histamine-1 receptor antagonist321
HMG-CoA reductase inhibitor844
Insulin analog320
Interferon beta263
Janus kinase inhibitor323
Kinase inhibitor1,855
Loop diuretic477
Nonsteroidal anti-inflammatory drug926
Nucleoside metabolic inhibitor577
Opioid agonist969
P2Y12 platelet inhibitor426
Parathyroid hormone analog424
Platinum-based drug486
Programmed death Receptor-1 blocking antibody400
Prostacycline vasodilator256
Proteasome inhibitor364
Proton pump inhibitor963
Serotonin and norepinephrine reuptake inhibitor359
Serotonin reuptake inhibitor1,156
Sphingosine 1-phosphate receptor modulator283
Thalidomide analog709
Tumor necrosis factor blocker1,086
Vascular endothelial growth factor inhibitor311

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

Reports by month

Reports that record Arrhythmia, 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 Arrhythmia
AgeReportsShareShare as a bar
Under 21930.4%
2 to 114080.9%
12 to 175801.2%
18 to 445,07710.9%
45 to 649,77420.9%
65 to 746,93314.8%
75 and over6,72714.4%
Age not given16,99936.4%
Sex of the patient in the reports that record Arrhythmia
SexReportsShareShare as a bar
Female22,85949%
Male18,90840.5%
Unknown or not given4,92410.5%

Age and sex are as the report gives them. 37.2% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Arrhythmia: adverse event reports that record this term. https://reportedreactions.com/reaction/arrhythmia/ 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 Arrhythmia 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 .

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 .