What the label lists and what reports show
Estradiol side effects
Estradiol's FDA label: “The most common adverse reactions (incidence ≥5 percent) with Yuvafem are: back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea.” FAERS holds 87,788 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is product adhesion issue (5,779 reports).
- Generic listed
- Boxed warning
Check it at the source: the estradiol FDA label on DailyMed (effective April 3, 2024, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What is the most important information I should know about Climara (an estrogen hormone)?Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Climara. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years of age and older. Do not use estrogens with progestogens to prevent heart disease, heart attacks, strokes or dementia. Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women age 65 years of age and older. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Climara will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Climara.
Source: FDA drug label (Climara), Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026 (SPL set 1e9702c4-f2d7-4ea8-b6e8-7dca31671864), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥5 percent) with Yuvafem are: back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea.
Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in…
| Reaction | Body System Adverse Reaction Placebo N = 103 n (%) | Treatment Number (%) of Women Yuvafem N = 205 n (%) |
|---|---|---|
| Back Pain | 2 (2) | 14 (7) |
| Diarrhea | 0 | 11 (5) |
| Vulvovaginal Mycotic Infection | 3 (3) | 17 (8) |
| Vulvovaginal Pruritus | 2 (2) | 16 (8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2) ] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.3) ] The most common adverse reactions (incidence ≥5 percent) with Yuvafem are: back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Yuvafem 10 mcg vaginal inserts. Adverse reactions with an incidence of ≥5 percent in the Yuvafem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.
Source: FDA drug label, Amneal Pharmaceuticals LLC, effective April 3, 2024 (SPL set 30c7f6ba-7a9e-4853-b3e4-e00a46560224), via openFDA; the full label on DailyMed
What do FAERS reports show?
87,788 reports list estradiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,562 are coded as a death and 11,970 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Estradiol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions