Drug Safety Information for PROPAFENONE Hydrochloride (Propafenone hydrochloride)

Safety-related Labeling Changes for RYTHMOL (PROPAFENONE HYDROCHLORIDE) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for PROPAFENONE Hydrochloride* (Propafenone hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PROPAFENONE Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Atrial fibrillation374
2Dizziness*237
3Drug ineffective*198
4Dyspnoea*186
5Nausea185
6Asthenia183
7Hypotension170
8Fatigue*170
9Fall143
10Diarrhoea124
11Product quality issue113
12Vomiting112
13Bradycardia108
14Drug interaction108
15Palpitations107
16Chest pain101
17Arrhythmia101
18Headache*98
19Malaise96
20Heart rate increased87

* This side effect also appears in "Top 10 Side Effects of PROPAFENONE Hydrochloride " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PROPAFENONE Hydrochloride
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Atrial fibrillation*2942
2Product used for unknown indication1597
3Arrhythmia1003
4Cardiac disorder225
5Heart rate irregular173
6Tachycardia142
7Atrial flutter126
8Supraventricular tachycardia*114
9Hypertension76
10Suicide attempt74

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PROPAFENONE Hydrochloride

Total Reports Filed with FDA: 14976


Number of FDA Adverse Event Reports by Patient Age for PROPAFENONE Hydrochloride

Total Reports Filed with FDA: 14976*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Propafenone hydrochloride (Propafenone hcl, Rythmol sr, Rythmol)

Charts are based on 14976 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PROPAFENONE Hydrochloride Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.