Drug Safety Information for VIVELLE (Estradiol)

Safety-related Labeling Changes for DELESTROGEN (ESTRADIOL VALERATE) Rx Drug: FDA Link

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

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

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

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

Safety-related Labeling Changes for VIVELLE-DOT (ESTRADIOL) Rx Drug: FDA Link

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

Safety-related Labeling Changes for COMBIPATCH (ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ACTIVELLA (ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

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

Safety-related Labeling Changes for PREFEST (ESTRADIOL; NORGESTIMATE) Rx Drug: FDA Link

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

Safety-related Labeling Changes for CLIMARA PRO (ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for FEMRING (ESTRADIOL ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ESTRASORB (ESTRADIOL HEMIHYDRATE) Discontinued Drug: FDA Link

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

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

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

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

Adverse Drug Reactions for VIVELLE* (Estradiol)

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 VIVELLE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer female2620
2Breast cancer2147
3Drug ineffective1731
4Nausea1540
5Headache*1378
6Product quality issue1243
7Fatigue1155
8Hot flush*1140
9Pain*1073
10Dizziness977
11Dyspnoea832
12Diarrhoea819
13Anxiety786
14Depression*786
15Insomnia778
16Arthralgia767
17Vomiting684
18Pain in extremity680
19Rash633
20Asthenia603

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

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

Reason # of FDA Reports
1Hormone replacement therapy*15949
2Product used for unknown indication9478
3Menopause*4607
4Menopausal symptoms*3356
5Hot flush*3083
6Vulvovaginal dryness*1456
7Hysterectomy*1253
8Hormone therapy1064
9Oestrogen replacement therapy872
10Atrophic vulvovaginitis*871

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


Types of Adverse Events for VIVELLE

Total Reports Filed with FDA: 107512


Number of FDA Adverse Event Reports by Patient Age for VIVELLE

Total Reports Filed with FDA: 107512*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estradiol (Estraderm tts 25, Esclim, Vivelle dot, Gynodiol, Estra-c, Estrace vaginal, Guna-beta-estradiol, Alora, Estraderm tts 100, Innofem, Climaval, Estraderm tts, Aerodiol, Estrate, Zumenon, Minivelle, Fempatch, Sandrena, Benztrone, Elleste-solo, Estra-d, Estraderm, Climara, Elestrin, Divigel, Estrace, Vagifem, Vivelle-dot, Menostar, Estradiol, Estrogel, Estring, Evamist, Vivelle)

Charts are based on 107512 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 VIVELLE 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.