Drug Safety Information for FASLODEX (Fulvestrant)

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

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

Adverse Drug Reactions for FASLODEX* (Fulvestrant)

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 FASLODEX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Fatigue	240
2	Nausea	238
3	Neoplasm malignant	229
4	Pain*	229
5	Dyspnoea	229
6	Osteonecrosis	227
7	Osteonecrosis of jaw	200
8	Arthralgia	195
9	Metastases to bone	191
10	Back pain	180
11	Death	169
12	Disease progression	159
13	Asthenia	152
14	Pain in extremity	143
15	Metastases to liver	141
16	Bone pain	137
17	Diarrhoea	136
18	Bone disorder	135
19	Vomiting*	135
20	Headache*	134

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

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

	Reason	# of FDA Reports
1	Breast cancer*	3223
2	Breast cancer metastatic*	2153
3	Product used for unknown indication	755
4	Breast cancer female	343
5	Breast cancer recurrent	156
6	Breast cancer stage iv	140
7	Lung neoplasm malignant	111
8	Neoplasm malignant	92
9	Metastases to bone	78
10	Non-small cell lung cancer	41

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

Types of Adverse Events for FASLODEX

Total Reports Filed with FDA: 23556

Number of FDA Adverse Event Reports by Patient Age for FASLODEX

Total Reports Filed with FDA: 23556*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fulvestrant (Faslodex)

Charts are based on 23556 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.