Drug Safety Information for BYDUREON (Exenatide synthetic)
FDA Safety-related Labeling Changes for BYETTA (EXENATIDE SYNTHETIC) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for BYETTA (EXENATIDE SYNTHETIC) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for BYDUREON (EXENATIDE SYNTHETIC) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for BYDUREON (EXENATIDE SYNTHETIC) Rx Drug: Safety Information Link
Required post-approval safety study:
A medullary thyroid carcinoma case series registry of at least 15 years duration to systematically monitor the annual incidence of medullary thyroid carcinoma in the United States and to identify any increase related to the introduction of BYDUREON (exenatide for injectable suspension) into the marketplace. This study will also establish a registry of incident cases of medullary thyroid carcinoma and characterize their medical histories related to diabetes and use of BYDUREON (exenatide for injectable suspension). Due Date: 2028-09-30
Original FDA Drug Approval Date for BYDUREON: 2012-01-27
Adverse Drug Reactions for BYDUREON* (Exenatide synthetic)
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 BYDUREON
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Blood glucose increased | 15533 |
2 | Weight decreased* | 12526 |
3 | Nausea* | 12440 |
4 | Decreased appetite* | 6704 |
5 | Blood glucose decreased | 5513 |
6 | Vomiting* | 4482 |
7 | Diarrhoea* | 2898 |
8 | Dizziness* | 2693 |
9 | Injection site pain | 2500 |
10 | Injection site haemorrhage | 2285 |
11 | Drug ineffective | 2222 |
12 | Pancreatitis | 2182 |
13 | Injection site haematoma | 2156 |
14 | Headache* | 2148 |
15 | Fatigue | 1758 |
16 | Feeling abnormal | 1601 |
17 | Asthenia | 1564 |
18 | Drug effect decreased | 1548 |
19 | Malaise* | 1517 |
20 | Tremor | 1508 |
* This side effect also appears in "Top 10 Side Effects of BYDUREON " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking BYDUREON
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Type 2 diabetes mellitus | 132432 |
2 | Diabetes mellitus* | 10814 |
3 | Product used for unknown indication | 7468 |
4 | Insulin-requiring type 2 diabetes mellitus | 2534 |
5 | Type 1 diabetes mellitus* | 1142 |
6 | Weight decreased* | 1020 |
7 | Glucose tolerance impaired | 889 |
8 | Insulin resistance* | 479 |
9 | Weight control | 404 |
10 | Obesity | 222 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for BYDUREON
Total Reports Filed with FDA: 187477
Number of FDA Adverse Event Reports by Patient Age for BYDUREON
Total Reports Filed with FDA: 187477*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Exenatide synthetic (Byetta, Bydureon)
Charts are based on 187477 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 BYDUREON 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.