ESTRIOL: 124 Adverse Event Reports & Safety Profile
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Route: CUTANEOUS · Manufacturer: Beijing JUNGE Technology Co., Ltd. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20000916 · Latest Report: 20241225
What Are the Most Common ESTRIOL Side Effects?
All ESTRIOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Blister | 22 | 17.7% | 0 | 0 |
| Conjunctivitis | 22 | 17.7% | 0 | 0 |
| Erythema | 22 | 17.7% | 0 | 0 |
| Mouth ulceration | 22 | 17.7% | 0 | 0 |
| Toxic epidermal necrolysis | 22 | 17.7% | 0 | 0 |
| Genital erosion | 16 | 12.9% | 0 | 0 |
| Mucosal erosion | 16 | 12.9% | 0 | 0 |
| Fatigue | 14 | 11.3% | 4 | 1 |
| Nausea | 12 | 9.7% | 0 | 7 |
| Headache | 10 | 8.1% | 0 | 2 |
| Vomiting | 9 | 7.3% | 0 | 5 |
| Dizziness | 8 | 6.5% | 0 | 6 |
| Arthralgia | 7 | 5.7% | 0 | 0 |
| Off label use | 7 | 5.7% | 0 | 1 |
| Pyrexia | 7 | 5.7% | 3 | 1 |
| Somnolence | 7 | 5.7% | 4 | 0 |
| Hyponatraemia | 6 | 4.8% | 0 | 6 |
| Lethargy | 6 | 4.8% | 3 | 1 |
| Pallor | 6 | 4.8% | 4 | 0 |
| Product use issue | 6 | 4.8% | 0 | 0 |
Who Reports ESTRIOL Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 64.9 years. Most reports from: DE. View detailed demographics →
Is ESTRIOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 21 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2013 | 2 | 0 | 1 |
| 2014 | 7 | 0 | 2 |
| 2015 | 8 | 0 | 0 |
| 2016 | 10 | 0 | 6 |
| 2017 | 9 | 0 | 2 |
| 2018 | 3 | 0 | 3 |
| 2019 | 6 | 0 | 0 |
| 2020 | 6 | 2 | 1 |
| 2021 | 2 | 0 | 1 |
| 2022 | 2 | 0 | 0 |
| 2024 | 9 | 0 | 1 |
What Is ESTRIOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Vulvovaginal disorder | 20 |
| Atrophic vulvovaginitis | 6 |
| Hormone replacement therapy | 5 |
ESTRIOL vs Alternatives: Which Is Safer?
Official FDA Label for ESTRIOL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
USES: This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes. DIRECTIONS: Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.
Dosage & Administration
Directions Cleanse hands and the external vulvar area with a mild, soap-free cleanser and pat dry. Apply a pea-sized amount (approx. 0.3 g) to the fingertip. Gently apply and massage into the dry areas of the vulva in a circular motion until fully absorbed. After an initial treatment of 2-3 weeks, reduce frequency to a maintenance level (e.g., twice a week).
Warnings
Warnings For external use only. Do not use If you are pregnant or breast-feeding. On minors under 18 years of age. If you have a known sensitivity to estrogen or a hormone-related condition (e.g., breast cancer, endometriosis). On open wounds, swollen areas, rashes, or active infections. When using this product Avoid contact with eyes. Stop use and ask a doctor if A burning sensation, itching, or redness occurs and persists. Condition worsens or symptoms last more than 7 days.
Precautions
1.
For Extemal Use
Only. 2.
Avoid Direct
Contact with Eyes. 3. If the product gets into your eyes, rinse immediately with plenty of water. 4. Ensure skin is not broken or severely irritated before use. 5. If any discomfort dor alergicreaction occurs, discontinue useimmediately and consult a doctor. 6.
Keep
Out of Reach of Children.
Active Ingredient
DRUG FACTS Active Ingredients Micronizrd Estriol USP (Wild Yam) .5%
Inactive Ingredients
Inactive ingredients AQUA, BUTYLENE GLYCOL, GLYCERIN, VITIS VINIFERA (GRAPE) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, COCO-GLUCOSIDE, TOCOPHEROL, ASIATICOSIDE, SOY ISOFLAVONES, DIOSCOREA OPPOSITIFOLIA (WILD YAM) ROOT, POLYGONUM CUSPIDATUM ROOT, PUERARIA MONTANA VAR. LOBATA ROOT, HYALURONIC ACID, SODIUM HYALURONATE, SODIUM BENZOATE, POTASSIUM SORBATE, CIMICIFUGA RACEMOSA ROOT, PUNICA GRANATUM FRUIT JUICE, TRIFOLIUM PRATENSE (CLOVER) FLOWER, CAMELLIA SINENSIS LEAF EXTRACT, PANAX GINSENG ROOT, AVENA SATIVA (OAT) KERNEL OIL, PALMITOYL PENTAPEPTIDE-4, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7, CITRUS BIOFLAVONOIDS, GLABRIDIN, GINKGO BILOBA LEAF, MYRICETIN, CRITHMUM MARITIMUM, ERYNGIUM MARITIMUM ROOT