Drug Safety Information for TOPROL-XL (Metoprolol succinate)

Safety-related Labeling Changes for TOPROL-XL (METOPROLOL SUCCINATE) Rx Drug: FDA Link

Adverse Drug Reactions for TOPROL-XL* (Metoprolol succinate)

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 TOPROL-XL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea3144
2Dyspnoea*2862
3Myocardial infarction2846
4Dizziness*2680
5Fatigue*2648
6Drug ineffective2442
7Diarrhoea2265
8Pain2248
9Headache*2058
10Asthenia2025
11Hypertension2011
12Chest pain1802
13Cardiac failure congestive1735
14Vomiting1698
15Anxiety*1633
16Fall1549
17Malaise1519
18Cerebrovascular accident1510
19Oedema peripheral1424
20Pain in extremity1416

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

Top 10 Reasons for Taking TOPROL-XL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension*27509
2Product used for unknown indication16389
3Blood pressure*3689
4Cardiac disorder2772
5Atrial fibrillation*1528
6Blood pressure abnormal1410
7Arrhythmia795
8Heart rate increased711
9Blood pressure increased608
10Heart rate irregular528

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


Types of Adverse Events for TOPROL-XL

Total Reports Filed with FDA: 239673


Number of FDA Adverse Event Reports by Patient Age for TOPROL-XL

Total Reports Filed with FDA: 239673*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metoprolol succinate (Toprol, Toprolxl, Metoprolol succinate, Toprol-xl)

Charts are based on 239673 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 TOPROL-XL 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.