Pharmacologic class (EPC) · 11 drug pages

Antiarrhythmic: adverse event reports filed with FDA

30,807 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

30,807
reports across the class: 0.2% of all reports; 1,259
reports, 12 months to June 2026: 2,025 in the 12 months before; 73.5%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Antiarrhythmic is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 30,807 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

1,259 reports arrived in the 12 months to June 2026, down 38% from 2,025 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 73.5% of the class's reports are marked serious, 10.1% record death among the outcomes and 33.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are atrial fibrillation (9%), drug ineffective (8.4%) and dyspnoea (6.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
TikosynDofetilide	brand	6,193	30	57.5%	Atrial fibrillation
MultaqDronedarone	brand	5,773	289	70.9%	Atrial fibrillation
Amiodarone hydrochloride	generic	5,286	382	92.7%	Dyspnoea
SotalolSotalol hydrochloride	brand	3,168	127	91.9%	Drug ineffective
NuedextaDextromethorphan hydrobromide and quinidine sulfate	brand	2,517	155	26.1%	Product use in unapproved indication
Dofetilide	generic	1,728	34	64.4%	Drug ineffective
Sotalol hydrochloride	generic	1,641	57	87.9%	Electrocardiogram QT prolonged
Flecainide acetate	generic	1,447	78	87.6%	Toxicity to various agents
Propafenone	generic	1,266	56	92.5%	Drug interaction
Propafenone hydrochloride	generic	1,071	18	80.4%	Atrial fibrillation
Dronedarone	generic	717	33	92.6%	Drug interaction

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Atrial fibrillationan irregular heart rhythm9%2,784
Drug ineffectivethe medicine did not work as expected8.4%2,584
Dyspnoeashortness of breath6.6%2,043
Drug interactionan interaction between medicines6%1,863
Dizzinesslight-headedness or unsteadiness5.2%1,594
Off label useused for a purpose or in a way not on the label5.1%1,569
Fatiguetiredness5.1%1,557
Astheniaweakness or lack of energy4.4%1,364
Electrocardiogram QT prolongeda QT prolongation on the ECG4.3%1,326
Nauseafeeling sick3.8%1,168
Bradycardiaslow heart rate3.3%1,004
Hypotensionlow blood pressure3.2%996
Product use in unapproved indicationused for a purpose not on the label2.9%882
Toxicity to various agentspoisoning or toxic effect of one or more substances2.7%845
Condition aggravatedthe condition being treated got worse2.6%812
Coughcough2.4%747
Diarrhoealoose or frequent stools2.4%729
Deaththe patient died; cause not stated by this term2.3%717
Malaisegeneral feeling of being unwell2.3%708
Arrhythmia2.2%681
Ventricular tachycardiaa fast rhythm from the lower heart chambers2.2%678
Headachehead pain2.1%657
Cardiac arrestthe heart stopped2.1%644
Vomitingbeing sick2%631
Torsade de pointesa serious irregular heart rhythm2%625

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.1%3,100

Life-threatening7.4%2,272

Hospitalisation (initial or prolonged)33.9%10,448

Disability2.3%700

Congenital anomaly0.4%132

Other serious48.8%15,039

Not serious26.5%8,168

Patient age

Under 20.5%167

2 to 110.4%124

12 to 170.6%180

18 to 444%1,231

45 to 6414.1%4,346

65 to 7418.8%5,779

75 and over25.4%7,836

Age not given36.2%11,144

Who reported

Physician24.2%7,453

Pharmacist8.8%2,726

Other health professional26%8,016

Lawyer0.8%238

Consumer or non-health professional36.5%11,239

Not given3.7%1,135

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Antiarrhythmic reports

Which drugs are in the Antiarrhythmic class on this site?

Tikosyn, Multaq, Amiodarone hydrochloride, Sotalol, Nuedexta and Dofetilide and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

30,807 reports through June 2026, 1,259 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

atrial fibrillation (9%), drug ineffective (8.4%), dyspnoea (6.6%), drug interaction (6%) and dizziness (5.2%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.