OSPEMIFENE: 2,047 Adverse Event Reports & Safety Profile
Boost Your Natural Energy & Metabolism
Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.
Drug Class: Estrogen Agonist/Antagonist [EPC] · Route: ORAL · Manufacturer: Duchesnay USA, Inc. · FDA Application: 203505 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Jul 9, 2028 · First Report: 2006 · Latest Report: 20241208
What Are the Most Common OSPEMIFENE Side Effects?
All OSPEMIFENE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 387 | 18.9% | 0 | 11 |
| Hot flush | 319 | 15.6% | 0 | 0 |
| Headache | 171 | 8.4% | 0 | 4 |
| Muscle spasms | 164 | 8.0% | 0 | 1 |
| No adverse event | 160 | 7.8% | 0 | 0 |
| Vaginal haemorrhage | 127 | 6.2% | 0 | 2 |
| Vaginal discharge | 112 | 5.5% | 0 | 0 |
| Labelled drug-drug interaction medication error | 104 | 5.1% | 0 | 2 |
| Hyperhidrosis | 95 | 4.6% | 0 | 0 |
| Nausea | 79 | 3.9% | 0 | 3 |
| Drug ineffective | 69 | 3.4% | 0 | 2 |
| Therapeutic response unexpected | 68 | 3.3% | 0 | 0 |
| Pain in extremity | 63 | 3.1% | 0 | 2 |
| Weight increased | 63 | 3.1% | 0 | 0 |
| Rash | 62 | 3.0% | 0 | 0 |
| Dizziness | 52 | 2.5% | 0 | 1 |
| Fatigue | 51 | 2.5% | 0 | 1 |
| Drug prescribing error | 47 | 2.3% | 0 | 0 |
| Pruritus | 44 | 2.2% | 0 | 2 |
| Alopecia | 43 | 2.1% | 0 | 0 |
Who Reports OSPEMIFENE Side Effects? Age & Gender Data
Gender: 99.8% female, 0.2% male. Average age: 61.7 years. Most reports from: US. View detailed demographics →
Is OSPEMIFENE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2013 | 22 | 0 | 0 |
| 2014 | 234 | 0 | 10 |
| 2015 | 283 | 0 | 8 |
| 2016 | 298 | 0 | 8 |
| 2017 | 242 | 0 | 10 |
| 2018 | 156 | 0 | 5 |
| 2019 | 42 | 0 | 4 |
| 2020 | 5 | 0 | 1 |
| 2021 | 10 | 0 | 2 |
| 2022 | 6 | 1 | 1 |
| 2023 | 6 | 0 | 0 |
| 2024 | 4 | 0 | 0 |
What Is OSPEMIFENE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 946 |
| Dyspareunia | 601 |
| Off label use | 346 |
| Vulvovaginal dryness | 282 |
| Atrophic vulvovaginitis | 169 |
| Atrophy | 20 |
| Urinary tract infection | 18 |
| Vulvovaginal pain | 15 |
| Vulvovaginal burning sensation | 14 |
| Vulvovaginal discomfort | 13 |
OSPEMIFENE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Estrogen Agonist/Antagonist [EPC]
Official FDA Label for OSPEMIFENE
Official prescribing information from the FDA-approved drug label.
Drug Description
OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1.
Figure
1: Chemical Structure The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24 H 23 ClO 2 , which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.
Figure
1</