What the label lists and what reports show
Ospemifene side effects
Ospemifene's FDA label: “The most common adverse reactions (≥1 percent) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.” FAERS holds 2,601 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 hot flush (372 reports).
- No generic listed
- Boxed warning
Check it at the source: the ospemifene FDA label on DailyMed (effective February 14, 2025, Duchesnay USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of OSPHENA?OSPHENA may cause serious side effects, including: See " What is the most important information I should know about OSPHENA? " Serious, but less common side effects include: stroke blood clots cancer of the lining of the uterus (womb) Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: unusual vaginal bleeding changes in vision or speech sudden new severe headaches pain in your chest or legs with or without shortness of breath, weakness and fatigue Less serious, but common side effects include: hot flushes (also known as hot flashes) vaginal discharge muscle spasms headache excessive sweating (hyperhidrosis) heavy vaginal bleeding (vaginal hemorrhage) night sweats These are not all the possible side effects of OSPHENA. For more information, ask your healthcare provider or pharmacist. […]
Source: FDA drug label, Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥1 percent) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
Table 2: Adverse Reactions Reported More Commonly in the OSPHENA Treatment Group (60 mg Once Daily) and at Frequency ≥1.0% in All Clinical Trials up to 52 Weeks (Safety Population)
| Reaction | Ospemifene 60 mg All Trials (N=847) % | Placebo (N=165) % |
|---|---|---|
| Headaches | 2.8 | 2.4 |
| Hot flush | 12.2 | 4.2 |
| Muscle spasms | 4.5 | 2.4 |
| Hyperhidrosis | 2.5 | 1.8 |
| Night sweats | 1.2 | 0.0 |
| Vaginal discharge | 6.0 | 0.6 |
| Vaginal hemorrhage | 1.3 | 0.0 |
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 (5.1) ] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2) ] The most common adverse reactions (≥1 percent) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-OSPHENA (1-855-677-4362) 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. The safety of OSPHENA has been assessed in ten phase 2/3 trials (N=2209) with doses ranging from 5 to 90 mg per day. The duration of treatment in these studies ranged from 6 weeks to 15 months. The majority of women (N=1683) had treatment exposure up to 12 weeks; 847 had up to 52 weeks (1 year) of exposure. …
Source: FDA drug label, Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,601 reports list ospemifene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 118 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 21 reactions below, 10 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?
- Ospemifene: 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