Cardiac operation 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 8,383 adverse event reports that record the MedDRA preferred term Cardiac operation. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 643 reports in the 12 months to June 2026 and 607 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 848 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, 643 (under 0.1%) record this term. Reports for male patients were 48.3% 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 139 drug pages with 10 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 Cardiac operation name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	10
Adempas	Soluble guanylate cyclase stimulator	37
Advair Diskus	Corticosteroid	68
Advair Hfa	Corticosteroid	58
Albuterol sulfate	beta2-Adrenergic agonist	30
Alendronate sodium	Bisphosphonate	12
Ambrisentan	Endothelin receptor antagonist	153
Amlodipine	Calcium channel blocker	11
Anoro Ellipta	Anticholinergic	21
Aranesp	Erythropoiesis-stimulating agent	26
Aspirin	Nonsteroidal anti-inflammatory drug	11
Avandamet		39
Avandia		283
Avonex	Interferon beta	89
Benlysta	B lymphocyte stimulator-specific inhibitor	17
Bosentan	Endothelin receptor antagonist	11
Breo Ellipta	Corticosteroid	31
Byetta	GLP-1 receptor agonist	15
Celebrex	Nonsteroidal anti-inflammatory drug	28
Certolizumab pegol	Tumor necrosis factor blocker	25
Cimzia	Tumor necrosis factor blocker	11
Coreg	alpha-Adrenergic blocker	15
Cosentyx	Interleukin-17A antagonist	26
Coumadin		15
Creon		38
Crestor	HMG-CoA reductase inhibitor	55
Cymbalta		12
Dilaudid	Opioid agonist	19
Diovan	Angiotensin 2 receptor blocker	21
Diovan HCT	Angiotensin 2 receptor blocker	14
Dupixent	Interleukin-4 receptor alpha antagonist	176
Eliquis	Factor Xa inhibitor	38
Enbrel	Tumor necrosis factor blocker	271
Eylea	Vascular endothelial growth factor inhibitor	13
Fentanyl	Opioid agonist	11
Fluticasone propionate and salmeterol	Corticosteroid	19
Forteo	Parathyroid hormone analog	54
Fosamax	Bisphosphonate	17
Hizentra	Human immunoglobulin G	19
Humalog	Insulin analog	80
Humalog Mix 75/25		11
Humira		342
Humulin 70/30	Insulin	23
Humulin N	Insulin	32
Humulin R	Insulin	25
Hydrocodone bitartrate and acetaminophen	Opioid agonist	29
Ibrance	Kinase inhibitor	23
Imbruvica	Kinase inhibitor	120
Insulin glargine	Insulin analog	27
Insulin human	Insulin	14
Janumet	Biguanide	12
Januvia	Dipeptidyl peptidase 4 inhibitor	19
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	113
Kevzara	Interleukin-6 receptor antagonist	16
Lantus	Insulin analog	129
Lantus Solostar	Insulin analog	103
Lenalidomide	Thalidomide analog	13
Letairis	Endothelin receptor antagonist	67
Levemir	Insulin analog	37
Lipitor	HMG-CoA reductase inhibitor	104
Lupron Depot		10
Lyrica		14
Macitentan	Endothelin receptor antagonist	23
Mepolizumab	Interleukin-5 antagonist	25
Morphine sulfate	Opioid agonist	19
MS Contin	Opioid agonist	15
Neurontin		15
Nexium	Proton pump inhibitor	43
Niaspan		10
Northera		14
Norvasc	Calcium channel blocker	17
Novolog	Insulin analog	58
Novorapid		14
Nucala	Interleukin-5 antagonist	19
Nuplazid	Atypical antipsychotic	17
Ofev	Kinase inhibitor	34
Opsumit	Endothelin receptor antagonist	141
Orencia	Selective T cell costimulation modulator	12
Orgovyx	Gonadotropin releasing hormone receptor antagonist	25
Otezla	Phosphodiesterase 4 inhibitor	43
Oxycodone and acetaminophen	Opioid agonist	23
Oxycodone hydrochloride	Opioid agonist	48
OxyContin	Opioid agonist	63
Ozempic	GLP-1 receptor agonist	61
Percocet	Opioid agonist	15
Plavix	P2Y12 platelet inhibitor	31
Pradaxa	Direct thrombin inhibitor	43
Praluent	PCSK9 inhibitor	40
Prograf	Calcineurin inhibitor immunosuppressant	14
Prolia	RANK ligand inhibitor	72
Ranolazine		187
Remicade	Tumor necrosis factor blocker	67
Remodulin	Prostacycline vasodilator	23
Repatha	PCSK9 inhibitor	280
Revatio	Phosphodiesterase 5 inhibitor	11
Rinvoq	Janus kinase inhibitor	119
Rivaroxaban	Factor Xa inhibitor	19
Rosiglitazone maleate		27
Sensipar	Calcium-sensing receptor agonist	32
Seroquel	Atypical antipsychotic	14
Sildenafil	Phosphodiesterase 5 inhibitor	40
Simponi	Tumor necrosis factor blocker	33
Skyrizi	Interleukin-23 antagonist	283
Solostar		15
Spravato		13
Stelara	Interleukin-12 antagonist	24
Synagis	Respiratory syncytial virus Anti-F protein monoclonal antibody	97
Synthroid	l-Thyroxine	34
Tadalafil	Phosphodiesterase 5 inhibitor	11
Taltz	Interleukin-17A antagonist	27
Tavneos	Complement 5a receptor antagonist	16
Tecfidera		28
Tiotropium bromide	Anticholinergic	24
Tolvaptan	Vasopressin V2 receptor antagonist	16
Toprol-Xl		17
Tracleer	Endothelin receptor antagonist	221
Tramadol		15
Trelegy Ellipta	Anticholinergic	54
Tremfya	Interleukin-23 antagonist	16
Tresiba	Insulin analog	23
Tysabri	Integrin receptor antagonist	25
Uptravi	Prostacyclin receptor agonist	34
Vedolizumab	Integrin receptor antagonist	20
Veletri	Prostacycline vasodilator	17
Veltassa		42
Venclexta	BCL-2 inhibitor	23
Ventavis		21
Ventolin Hfa	beta2-Adrenergic agonist	43
Viagra	Phosphodiesterase 5 inhibitor	25
Victoza	GLP-1 receptor agonist	24
Vioxx		26
Vyndamax		22
Wegovy	GLP-1 receptor agonist	20
Xarelto	Factor Xa inhibitor	120
Xeljanz	Janus kinase inhibitor	98
Xtandi	Androgen receptor inhibitor	15
Xyrem	Central nervous system depressant	22
Zelnorm		11
Zyprexa	Atypical antipsychotic	19

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 25 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 Cardiac operation name, in order of name
Class	Reports with this term
alpha-Adrenergic blocker	30
Angiotensin 2 receptor blocker	49
Anticholinergic	109
Atypical antipsychotic	75
BCL-2 inhibitor	25
beta2-Adrenergic agonist	75
Bisphosphonate	29
Calcineurin inhibitor immunosuppressant	27
Calcium channel blocker	30
Calcium-sensing receptor agonist	32
Central nervous system depressant	30
Corticosteroid	198
Dipeptidyl peptidase 4 inhibitor	32
Direct thrombin inhibitor	43
Endothelin receptor antagonist	616
Erythropoiesis-stimulating agent	28
Factor Xa inhibitor	182
GLP-1 receptor agonist	124
Gonadotropin releasing hormone receptor antagonist	25
HMG-CoA reductase inhibitor	167
Insulin	97
Insulin analog	478
Integrin receptor antagonist	45
Interferon beta	97
Interleukin-12 antagonist	26
Interleukin-17A antagonist	53
Interleukin-23 antagonist	299
Interleukin-4 receptor alpha antagonist	178
Interleukin-5 antagonist	44
Janus kinase inhibitor	224
Kinase inhibitor	216
l-Thyroxine	34
Nonsteroidal anti-inflammatory drug	45
Opioid agonist	282
P2Y12 platelet inhibitor	43
Parathyroid hormone analog	54
PCSK9 inhibitor	324
Phosphodiesterase 4 inhibitor	43
Phosphodiesterase 5 inhibitor	99
Prostacyclin receptor agonist	36
Prostacycline vasodilator	44
Proton pump inhibitor	45
RANK ligand inhibitor	72
Respiratory syncytial virus Anti-F protein monoclonal antibody	97
Sodium-Glucose cotransporter 2 inhibitor	125
Soluble guanylate cyclase stimulator	37
Tumor necrosis factor blocker	423

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

Reports by month

Reports that record Cardiac operation, 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 Cardiac operation
Age	Reports	Share
Under 2	142	1.7%
2 to 11	109	1.3%
12 to 17	38	0.5%
18 to 44	305	3.6%
45 to 64	1,754	20.9%
65 to 74	1,500	17.9%
75 and over	1,046	12.5%
Age not given	3,489	41.6%

Sex of the patient in the reports that record Cardiac operation
Sex	Reports	Share
Female	3,749	44.7%
Male	4,050	48.3%
Unknown or not given	584	7%

Age and sex are as the report gives them. 83% 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. Cardiac operation: adverse event reports that record this term. https://reportedreactions.com/reaction/cardiac-operation/ 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 Cardiac operation 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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