Cardiotoxicity 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 8,740 adverse event reports that record the MedDRA preferred term Cardiotoxicity. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 785 reports in the 12 months to June 2026 and 852 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 734 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, 785 (0.1%) record this term. Reports for female patients were 41.5% of the reports that record this term and 52.7% 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 136 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 Cardiotoxicity name as a suspect product, in order of name
Drug	Class	Reports with this term
5-fluorouracil		45
Acetaminophen		49
Adriamycin		86
Amitriptyline		61
Amlodipine	Calcium channel blocker	172
Aspirin	Nonsteroidal anti-inflammatory drug	33
Atenolol	beta-Adrenergic blocker	51
Atezolizumab	Programmed death Receptor-1 blocking antibody	27
Avastin	Vascular endothelial growth factor inhibitor	44
Baclofen	gamma-Aminobutyric acid-ergic agonist	31
Bevacizumab	Vascular endothelial growth factor inhibitor	141
Bisoprolol	beta-Adrenergic blocker	32
Bleomycin	Cytoprotective agent	70
Bortezomib	Proteasome inhibitor	78
Bupivacaine hydrochloride	Amide local anesthetic	38
Bupropion	Aminoketone	115
Bupropion hydrochloride	Aminoketone	85
Busulfan	Alkylating drug	47
Calquence	Kinase inhibitor	35
Capecitabine	Nucleoside metabolic inhibitor	336
Carboplatin	Platinum-based drug	290
Carfilzomib	Proteasome inhibitor	57
Carmustine	Alkylating drug	29
Carvedilol	alpha-Adrenergic blocker	38
Cisplatin	Platinum-based drug	204
Citalopram	Serotonin reuptake inhibitor	69
Citalopram hydrobromide	Serotonin reuptake inhibitor	30
Clonazepam	Benzodiazepine	36
Clozapine	Atypical antipsychotic	67
Cyclophosphamide	Alkylating drug	1,024
Cytarabine	Nucleoside metabolic inhibitor	258
Dacarbazine	Alkylating drug	67
Dasatinib	Kinase inhibitor	26
Daunorubicin		87
Dexamethasone	Corticosteroid	241
Diazepam	Benzodiazepine	59
Diltiazem		39
Docetaxel	Microtubule inhibitor	313
Doxil	Anthracycline topoisomerase inhibitor	53
Doxorubicin	Anthracycline topoisomerase inhibitor	851
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	529
Endoxan		28
Enhertu		25
Epinephrine	Catecholamine	60
Epirubicin		174
Epirubicin hydrochloride	Anthracycline topoisomerase inhibitor	62
Escitalopram	Serotonin reuptake inhibitor	29
Etoposide	Topoisomerase inhibitor	385
Filgrastim	Leukocyte growth factor	39
Flecainide		44
Fluconazole	Azole antifungal	25
Fludarabine	Nucleoside metabolic inhibitor	49
Fludarabine phosphate	Nucleoside metabolic inhibitor	25
Fluorouracil	Nucleoside metabolic inhibitor	488
Fluoxetine	Serotonin reuptake inhibitor	55
Furosemide	Loop diuretic	26
Gemcitabine	Nucleoside metabolic inhibitor	94
Herceptin	HER2/neu receptor antagonist	291
Hydroxychloroquine	Antimalarial	174
Hydroxychloroquine sulfate	Antimalarial	28
Ibrutinib (form s4)	Kinase inhibitor	43
Ifex	Alkylating drug	47
Ifosfamide	Alkylating drug	116
Imatinib	Kinase inhibitor	64
Imbruvica	Kinase inhibitor	80
Insulin glargine	Insulin analog	38
Irinotecan		49
Itraconazole	Azole antifungal	62
Kadcyla		51
Keytruda	Programmed death Receptor-1 blocking antibody	52
Kyprolis	Proteasome inhibitor	41
Lacosamide		60
Lamotrigine	Anti-epileptic agent	53
Lapatinib	Kinase inhibitor	44
Lenalidomide	Thalidomide analog	72
Letrozole	Aromatase inhibitor	49
Leucovorin		63
Leucovorin calcium	Folate analog	35
Levetiracetam		63
Lidocaine	Amide local anesthetic	71
Lisinopril	Angiotensin converting enzyme inhibitor	38
Loperamide		89
Loperamide hydrochloride	Opioid agonist	45
Lorazepam	Benzodiazepine	47
Melphalan	Alkylating drug	54
Metformin	Biguanide	27
Methadone	Opioid agonist	25
Methotrexate	Folate analog metabolic inhibitor	254
Methotrexate sodium	Folate analog metabolic inhibitor	38
Methylprednisolone	Corticosteroid	34
Metoprolol	beta-Adrenergic blocker	59
Mirtazapine		42
Mitoxantrone	Topoisomerase inhibitor	42
Mycophenolate mofetil	Antimetabolite immunosuppressant	46
Nivolumab	Programmed death Receptor-1 blocking antibody	38
Olanzapine	Atypical antipsychotic	66
Ondansetron	Serotonin-3 receptor antagonist	41
Osimertinib	Kinase inhibitor	32
Oxaliplatin	Platinum-based drug	278
Oxazepam	Benzodiazepine	25
Paclitaxel	Microtubule inhibitor	285
Pembrolizumab	Programmed death Receptor-1 blocking antibody	104
Pemetrexed	Folate analog metabolic inhibitor	29
Perindopril		33
Perjeta	HER2/neu receptor antagonist	144
Pertuzumab	HER2/neu receptor antagonist	165
Prednisolone	Corticosteroid	95
Prednisone	Corticosteroid	342
Pregabalin		37
Procytox		60
Propofol	General anesthetic	26
Propranolol	beta-Adrenergic blocker	39
Propranolol hydrochloride	beta-Adrenergic blocker	28
Quetiapine	Atypical antipsychotic	87
Risperidone	Atypical antipsychotic	25
Rituximab	CD20-directed cytolytic antibody	437
Sorafenib	Kinase inhibitor	36
Sutent	Kinase inhibitor	26
Tacrolimus	Calcineurin inhibitor immunosuppressant	45
Tagrisso	Kinase inhibitor	38
Taxol		32
Taxotere		28
Tocilizumab	Interleukin-6 receptor antagonist	273
Tramadol		25
Trastuzumab	HER2/neu receptor antagonist	901
Velcade	Proteasome inhibitor	58
Venetoclax	BCL-2 inhibitor	35
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	143
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	49
Verapamil		64
Vinblastine		52
Vincristine		424
Vincristine sulfate	Vinca alkaloid	68
Vinorelbine	Vinca alkaloid	38
Xeloda	Nucleoside metabolic inhibitor	82
Zopiclone		26

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 56 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 Cardiotoxicity name, in order of name
Class	Reports with this term
Alkylating drug	1,435
alpha-Adrenergic blocker	46
Amide local anesthetic	148
Aminoketone	221
Angiotensin 2 receptor blocker	43
Angiotensin converting enzyme inhibitor	72
Anthracycline topoisomerase inhibitor	1,511
Anti-epileptic agent	119
Antiarrhythmic	28
Antimalarial	208
Antimetabolite immunosuppressant	54
Aromatase inhibitor	73
Atypical antipsychotic	293
Azole antifungal	107
BCL-2 inhibitor	37
Benzodiazepine	244
beta-Adrenergic blocker	259
Biguanide	35
Calcineurin inhibitor immunosuppressant	75
Calcium channel blocker	174
Catecholamine	79
CD20-directed cytolytic antibody	447
Corticosteroid	746
Cytochrome P450 17A1 inhibitor	25
Cytoprotective agent	88
Dihydropyridine calcium channel blocker	40
Folate analog	47
Folate analog metabolic inhibitor	330
gamma-Aminobutyric acid-ergic agonist	31
General anesthetic	26
HER2/neu receptor antagonist	1,501
Histamine-1 receptor antagonist	27
Insulin analog	44
Interleukin-6 receptor antagonist	273
Kinase inhibitor	721
Leukocyte growth factor	43
Loop diuretic	26
Microtubule inhibitor	604
Mood stabilizer	64
Nonsteroidal anti-inflammatory drug	59
Nucleoside metabolic inhibitor	1,399
Opioid agonist	133
Osmotic laxative	29
P2Y12 platelet inhibitor	28
Platinum-based drug	772
Programmed death Ligand-1 blocker	25
Programmed death Receptor-1 blocking antibody	238
Proteasome inhibitor	246
Serotonin and norepinephrine reuptake inhibitor	220
Serotonin reuptake inhibitor	248
Serotonin-3 receptor antagonist	41
Thalidomide analog	104
Topoisomerase inhibitor	460
Tricyclic antidepressant	31
Vascular endothelial growth factor inhibitor	185
Vinca alkaloid	110

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

Reports by month

Reports that record Cardiotoxicity, 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 Cardiotoxicity
Age	Reports	Share
Under 2	58	0.7%
2 to 11	282	3.2%
12 to 17	224	2.6%
18 to 44	1,371	15.7%
45 to 64	1,808	20.7%
65 to 74	897	10.3%
75 and over	441	5%
Age not given	3,659	41.9%

Sex of the patient in the reports that record Cardiotoxicity
Sex	Reports	Share
Female	3,626	41.5%
Male	2,410	27.6%
Unknown or not given	2,704	30.9%

Age and sex are as the report gives them. 29.1% 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. Cardiotoxicity: adverse event reports that record this term. https://reportedreactions.com/reaction/cardiotoxicity/ 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 Cardiotoxicity 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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