Drug Safety Information for TENORETIC 100 (Atenolol; chlorthalidone)

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

Adverse Drug Reactions for TENORETIC 100* (Atenolol; chlorthalidone)

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 TENORETIC 100
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea77
2Dizziness*56
3Drug ineffective*56
4Fatigue*54
5Pain in extremity52
6Hypertension*52
7Vomiting52
8Hypokalaemia51
9Headache48
10Dyspnoea46
11Diarrhoea45
12Pain43
13Asthenia42
14Blood pressure increased42
15Depression40
16Fall39
17Hyponatraemia38
18Malaise*36
19Dehydration34
20Chest pain34

* This side effect also appears in "Top 10 Side Effects of TENORETIC 100 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TENORETIC 100
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension*1329
2Product used for unknown indication424
3Blood pressure*114
4Essential hypertension66
5Blood pressure abnormal64
6Mitral valve prolapse47
7Blood pressure increased47
8Insomnia28
9Antiplatelet therapy19
10Stent placement19

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


Types of Adverse Events for TENORETIC 100

Total Reports Filed with FDA: 5405


Number of FDA Adverse Event Reports by Patient Age for TENORETIC 100

Total Reports Filed with FDA: 5405*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Atenolol; chlorthalidone (Tenoretic, Tenoretic 50, Tenoretic 100)

Charts are based on 5405 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 TENORETIC 100 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.