Drug Safety Information for VAGIFEM (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 VAGIFEM* (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 VAGIFEM
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Breast cancer female | 2620 |
2 | Breast cancer | 2147 |
3 | Drug ineffective | 1731 |
4 | Nausea | 1540 |
5 | Headache* | 1378 |
6 | Product quality issue | 1243 |
7 | Fatigue | 1155 |
8 | Hot flush* | 1140 |
9 | Pain* | 1073 |
10 | Dizziness | 977 |
11 | Dyspnoea | 832 |
12 | Diarrhoea | 819 |
13 | Anxiety | 786 |
14 | Depression* | 786 |
15 | Insomnia | 778 |
16 | Arthralgia | 767 |
17 | Vomiting | 684 |
18 | Pain in extremity | 680 |
19 | Rash | 633 |
20 | Asthenia | 603 |
* This side effect also appears in "Top 10 Side Effects of VAGIFEM " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking VAGIFEM
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Hormone replacement therapy* | 15949 |
2 | Product used for unknown indication | 9478 |
3 | Menopause* | 4607 |
4 | Menopausal symptoms* | 3356 |
5 | Hot flush* | 3083 |
6 | Vulvovaginal dryness* | 1456 |
7 | Hysterectomy* | 1253 |
8 | Hormone therapy | 1064 |
9 | Oestrogen replacement therapy | 872 |
10 | Atrophic vulvovaginitis* | 871 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for VAGIFEM
Total Reports Filed with FDA: 107512
Number of FDA Adverse Event Reports by Patient Age for VAGIFEM
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 VAGIFEM 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.