Drug Safety Information for BETAPACE AF (Sotalol hydrochloride)

Safety-related Labeling Changes for SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for BETAPACE AF* (Sotalol 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 BETAPACE AF
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Atrial fibrillation644
2Dyspnoea449
3Nausea382
4Dizziness*377
5Fatigue*338
6Asthenia306
7Diarrhoea*290
8Hypotension288
9Drug interaction286
10Drug ineffective264
11Fall244
12Bradycardia241
13Vomiting222
14Malaise207
15Headache*198
16Chest pain193
17Arrhythmia191
18Pain191
19Oedema peripheral185
20Electrocardiogram qt prolonged179

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

Top 10 Reasons for Taking BETAPACE AF
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Atrial fibrillation*2889
2Product used for unknown indication2678
3Arrhythmia1214
4Hypertension845
5Cardiac disorder546
6Ventricular tachycardia*200
7Heart rate irregular193
8Atrial flutter182
9Supraventricular tachycardia*167
10Tachycardia102

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


Types of Adverse Events for BETAPACE AF

Total Reports Filed with FDA: 32147


Number of FDA Adverse Event Reports by Patient Age for BETAPACE AF

Total Reports Filed with FDA: 32147*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sotalol hydrochloride (Darob, Beta-cardone, Sorine, Sotalol, Sotacor, Betapace, Betapace af, Sotylize)

Charts are based on 32147 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 BETAPACE AF Reviews and Review Summary .

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.

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