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 | |
---|---|---|
1 | Nausea | 77 |
2 | Dizziness* | 56 |
3 | Drug ineffective* | 56 |
4 | Fatigue* | 54 |
5 | Pain in extremity | 52 |
6 | Hypertension* | 52 |
7 | Vomiting | 52 |
8 | Hypokalaemia | 51 |
9 | Headache | 48 |
10 | Dyspnoea | 46 |
11 | Diarrhoea | 45 |
12 | Pain | 43 |
13 | Asthenia | 42 |
14 | Blood pressure increased | 42 |
15 | Depression | 40 |
16 | Fall | 39 |
17 | Hyponatraemia | 38 |
18 | Malaise* | 36 |
19 | Dehydration | 34 |
20 | Chest pain | 34 |
* 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 | |
---|---|---|
1 | Hypertension* | 1329 |
2 | Product used for unknown indication | 424 |
3 | Blood pressure* | 114 |
4 | Essential hypertension | 66 |
5 | Blood pressure abnormal | 64 |
6 | Mitral valve prolapse | 47 |
7 | Blood pressure increased | 47 |
8 | Insomnia | 28 |
9 | Antiplatelet therapy | 19 |
10 | Stent placement | 19 |
*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.