Drug Safety Information for AFINITOR (Everolimus)

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

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

Safety-related Labeling Changes for AFINITOR DISPERZ (EVEROLIMUS) Rx Drug: FDA Link

Required post-approval safety study:

To submit the clinical study report and datasets for the final analysis of overall survival (OS) for Trial CRAD001T2302, entitled ""A randomized, double-blind, multicenter, phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin - RADIANT-4,"" and to include the final OS data in the product label. Due Date: 2022-12-31

Original FDA Drug Approval Date for AFINITOR: 2009-03-30

Adverse Drug Reactions for AFINITOR* (Everolimus)

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 AFINITOR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	1852
2	Neoplasm malignant	1544
3	Dyspnoea	1123
4	Pyrexia	1004
5	Diarrhoea	899
6	Stomatitis	834
7	Fatigue	827
8	Cough	647
9	Anaemia	633
10	Nausea	630
11	Pneumonia	565
12	Vomiting	555
13	Asthenia	494
14	Blood creatinine increased	488
15	Decreased appetite	477
16	Oedema peripheral	472
17	Rash	463
18	Pneumonitis	444
19	Malaise	417
20	Neoplasm progression	414

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

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

	Reason	# of FDA Reports
1	Metastatic renal cell carcinoma	4840
2	Breast cancer	4746
3	Renal transplant	4516
4	Renal cell carcinoma	4444
5	Breast cancer metastatic	4432
6	Pancreatic neuroendocrine tumour	2424
7	Heart transplant	1994
8	Renal cancer	1661
9	Product used for unknown indication	1322
10	Neuroendocrine tumour	1318

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

Types of Adverse Events for AFINITOR

Total Reports Filed with FDA: 58374

Number of FDA Adverse Event Reports by Patient Age for AFINITOR

Total Reports Filed with FDA: 58374*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Everolimus (Certican, Rad 001, Rad001, Zortress, Afinitor disperz, Afinitor)

Charts are based on 58374 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.

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.