Short answer: In the label's 12-week placebo-controlled trial, the most common Elestrin side effects were breast tenderness (6.6% on 0.87 g/day and 7.7% on 1.7 g/day vs 3.6% on placebo), metrorrhagia or bleeding between periods (4.4% and 9.2% vs 2.2%), nasopharyngitis and upper respiratory infection. Elestrin carries the estrogen boxed warning on endometrial cancer, stroke, blood clots, probable dementia and breast cancer.
What Elestrin is approved for: Elestrin is an estradiol gel rubbed into the upper arm. It is approved to treat moderate to severe hot flashes (vasomotor symptoms) due to menopause (section 1.1). The label says a woman with a uterus generally also needs a progestin to reduce the risk of endometrial cancer (section 2).
Source
ELESTRIN (estradiol gel) 0.06%, prescribing information, Patient Information and Instructions for Use. Viatris Specialty (Meda Pharmaceuticals). DailyMed, version published August 25, 2025. DailyMed setid eff2dea1-f117-11e3-ac10-0800200c9a66
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
Estrogen-alone therapy: a woman with a uterus who uses estrogen without a progestin has a higher risk of endometrial cancer, and unexplained or repeated abnormal bleeding is checked. In the Women's Health Initiative (WHI), daily oral conjugated estrogens (CE) 0.625 mg alone raised the risk of stroke and deep vein thrombosis over 7.1 years, and the WHI Memory Study found a higher risk of probable dementia in women 65 and older. Estrogen plus progestin therapy: CE plus medroxyprogesterone acetate (MPA) 2.5 mg raised the risk of DVT, pulmonary embolism, stroke, heart attack, invasive breast cancer and probable dementia. Neither is to be used to prevent heart disease or dementia. Only those oral doses were studied, so the label says the relevance to other doses, routes or products is not known and the risks cannot be definitively excluded. Estrogens are prescribed at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Elestrin.
| Adverse reaction | Placebo (n=137) | Elestrin 0.87 g/day (n=136) | Elestrin 1.7 g/day (n=142) |
|---|---|---|---|
| Breast tenderness | 5 (3.6) | 9 (6.6) | 11 (7.7) |
| Metrorrhagia | 3 (2.2) | 6 (4.4) | 13 (9.2) |
| Nasopharyngitis | 10 (7.3) | 14 (10.3) | 12 (8.5) |
| Upper respiratory tract infection | 5 (3.6) | 8 (5.9) | 5 (3.5) |
12-week placebo-controlled trial in postmenopausal women with frequent moderate to severe hot flashes. 0.87 g of gel is one pump (0.52 mg estradiol); 1.7 g holds 1.04 mg estradiol. Cells are number of women (percent).
Daily hot flashes fell by 8.5 a day on 0.87 g and 10.0 on 1.7 g by week 12, vs 5.4 on placebo, from a baseline of about 13 a day (Table 3). The 1.7 g dose separated from placebo at week 4; the 0.87 g dose at week 5.
Applying sunscreen 10 minutes before Elestrin raised estradiol exposure by about 55 percent; sunscreen on the same site for 7 days raised it about 2-fold. Sunscreen 25 minutes after Elestrin made no significant change.
In a transfer study, men who had 5 minutes of arm-to-arm contact 2 or 8 hours after a woman applied Elestrin showed no significant change in estradiol levels.
WHI CE alone vs placebo, per 10,000 women-years: stroke 45 vs 33; VTE 30 vs 22; DVT 23 vs 15. CE plus MPA vs placebo: stroke 33 vs 25; DVT 26 vs 13; pulmonary embolism 18 vs 8.
Reported after approval include bleeding pattern changes, spotting, breast tenderness and enlargement, blood clots, heart attack, stroke, raised blood pressure, nausea, gallbladder disease, melasma, scalp hair loss, migraine, mood changes, weight change, edema and allergic reactions.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Women with undiagnosed abnormal genital bleeding, current or past breast cancer, estrogen-dependent cancer, active or past DVT, pulmonary embolism, stroke or heart attack, a known anaphylactic reaction, angioedema or hypersensitivity with Elestrin, liver impairment or disease, or protein C, protein S or antithrombin deficiency or other clotting disorders.
Blood clots, stroke and heart attack. Estrogen alone raised the risk of stroke and DVT; estrogen plus progestin raised the risk of pulmonary embolism, DVT, stroke and heart attack. Treatment is stopped right away if one occurs or is suspected, and if feasible 4 to 6 weeks before surgery linked to clots.
Endometrial, breast and ovarian cancer. Estrogen without a progestin raises endometrial cancer risk in women with a uterus. CE plus MPA raised invasive breast cancer risk in the WHI, and hormone therapy has been linked to more abnormal mammograms and to ovarian cancer.
Probable dementia. In women 65 to 79, probable dementia was more common on CE alone and on CE plus MPA than on placebo. Whether this applies to younger women is unknown.
Gallbladder, calcium, vision and blood pressure. Estrogens are linked to a 2- to 4-fold rise in gallbladder disease needing surgery (5.4), severe high calcium in breast cancer spread to bone (5.5), retinal blood clots (5.6), rare blood pressure rises (5.8) and high triglycerides with pancreatitis (5.9).
Thyroid, fluid and other conditions. Women on thyroid hormone may need higher doses. Estrogens can cause fluid retention, low calcium in hypoparathyroidism, and worsen endometriosis, hereditary angioedema, asthma, diabetes, epilepsy, migraine, porphyria, lupus and liver hemangiomas (sections 5.11 to 5.16).
Sunscreen and fire. Sunscreen raises estradiol absorption, so it is not put on the gel site until at least 25 minutes after Elestrin, and not on that site for 7 or more days in a row (5.18). The gel contains alcohol and is flammable until dry (5.19). Sun sensitivity at the site has not been studied (5.17).
From the Patient Information that comes with Elestrin:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.