Drug Safety Information for METOPROLOL TARTRATE (Metoprolol tartrate)

Safety-related Labeling Changes for LOPRESSOR (METOPROLOL TARTRATE) Rx Drug: FDA Link

Adverse Drug Reactions for METOPROLOL TARTRATE* (Metoprolol tartrate)

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 METOPROLOL TARTRATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea*5151
2Nausea5022
3Myocardial infarction4788
4Fatigue*4318
5Dizziness*4267
6Drug ineffective4065
7Diarrhoea4048
8Pain3705
9Asthenia3633
10Vomiting2981
11Cardiac failure congestive2945
12Headache2935
13Chest pain2901
14Hypotension2897
15Fall2858
16Atrial fibrillation2685
17Pneumonia2640
18Hypertension2598
19Pain in extremity2333
20Death2318

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

Top 10 Reasons for Taking METOPROLOL TARTRATE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication51238
2Hypertension*51227
3Blood pressure7080
4Cardiac disorder5530
5Atrial fibrillation*4256
6Blood pressure abnormal3272
7Blood pressure increased1233
8Coronary artery disease1193
9Heart rate increased1089
10Arrhythmia1024

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


Types of Adverse Events for METOPROLOL TARTRATE

Total Reports Filed with FDA: 411264


Number of FDA Adverse Event Reports by Patient Age for METOPROLOL TARTRATE

Total Reports Filed with FDA: 411264*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metoprolol tartrate (Metoprolol, Lopressor)

Charts are based on 411264 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 METOPROLOL TARTRATE 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.