Drug Safety Information for TENORMIN (Atenolol)

Safety-related Labeling Changes for TENORMIN (ATENOLOL) Rx Drug: FDA Link

Safety-related Labeling Changes for TENORETIC 100 (ATENOLOL; CHLORTHALIDONE) Rx Drug: FDA Link

Safety-related Labeling Changes for TENORETIC 50 (ATENOLOL; CHLORTHALIDONE) Rx Drug: FDA Link

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

Adverse Drug Reactions for TENORMIN* (Atenolol)

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 TENORMIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea3857
2Dizziness*3346
3Drug ineffective3257
4Dyspnoea3250
5Fatigue*3021
6Diarrhoea2922
7Headache*2698
8Pain2669
9Asthenia2598
10Vomiting2299
11Hypertension2240
12Fall2204
13Chest pain2005
14Malaise1911
15Myocardial infarction1907
16Hypotension1875
17Arthralgia1848
18Pain in extremity1813
19Oedema peripheral1785
20Anxiety1700

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

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

Reason # of FDA Reports
1Hypertension*48053
2Product used for unknown indication23014
3Blood pressure*5358
4Cardiac disorder2525
5Blood pressure abnormal1727
6Atrial fibrillation*1350
7Blood pressure increased1208
8Heart rate increased1052
9Arrhythmia966
10Tachycardia*894

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


Types of Adverse Events for TENORMIN

Total Reports Filed with FDA: 307571


Number of FDA Adverse Event Reports by Patient Age for TENORMIN

Total Reports Filed with FDA: 307571*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Atenolol (Tenormin, Tenormine, Atenix, Atenolol)

Charts are based on 307571 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 TENORMIN 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.