Drug Safety Information for EVISTA (Raloxifene hydrochloride)

Safety-related Labeling Changes for EVISTA (RALOXIFENE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for EVISTA* (Raloxifene hydrochloride)

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 EVISTA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea638
2Fall614
3Drug ineffective522
4Dizziness483
5Pain*437
6Pain in extremity*424
7Arthralgia*409
8Fatigue404
9Dyspnoea400
10Headache*393
11Muscle spasms*384
12Asthenia372
13Diarrhoea354
14Back pain334
15Oedema peripheral304
16Vomiting296
17Breast cancer293
18Feeling abnormal266
19Insomnia*254
20Cerebrovascular accident248

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

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

Reason # of FDA Reports
1Osteoporosis*13498
2Product used for unknown indication2233
3Osteopenia*1479
4Osteoporosis postmenopausal724
5Osteoporosis prophylaxis646
6Bone disorder575
7Prophylaxis464
8Hormone replacement therapy326
9Hormone level abnormal191
10Bone density decreased168

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


Types of Adverse Events for EVISTA

Total Reports Filed with FDA: 48003


Number of FDA Adverse Event Reports by Patient Age for EVISTA

Total Reports Filed with FDA: 48003*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Raloxifene hydrochloride (Raloxifene hcl, Raloxifene, Evista)

Charts are based on 48003 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 EVISTA 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.