"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Osphena Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Osphena (ospemifene) is a non-estrogen drug prescribed for painful intercourse (dyspareunia), which is a symptom of vulvar and vagina muscular wasting (vaginal atrophy), due to menopause. Side effects from the use of Osphena include hot flush, vaginal discharge, muscle spasms, and excessive sweating.
The dose of Osphena is a 60 mg tablet, taken once daily with food. Osphena may interact with fluconazole (Diflucan), rifampin (Rifadin), and estrogens. Women who are pregnant and women who may become pregnant should not use Osphena. Osphena may cause fetal harm when given to a pregnant woman. Consult your doctor before breastfeeding.
Our Osphena (ospemifene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Osphena FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
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 nine phase 2/3 trials (N=1892) with doses ranging from 5 to 90 mg per day. The duration of treatment in these studies ranged from 6 weeks to 15 months. Most women (N=1370) had a treatment period of at least 12 weeks, 409 had at least 52 weeks (1 year) of exposure.
The incidence rates of thromboembolic and hemorrhagic stroke were 0.72 per thousand women (1 reported case of thromboembolic stroke) and 1.45 per thousand women (2 reported cases of hemorrhagic stroke), respectively in OSPHENA 60 mg treatment group and 1.04 and 0 per thousand women, respectively in placebo. The incidence of deep vein thrombosis (DVT) was 1.45 per thousand women in OSPHENA 60 mg treatment group (2 reported cases of DVT) and 1.04 (1 case of DVT) in placebo.
Table 1 lists adverse reactions occurring more frequently in the OSPHENA 60 mg treatment group than in placebo and at a frequency ≥1%.
Table 1: Adverse Reactions Reported More Common in the
OSPHENA Treatment Group (60 mg Once Daily) and at Frequency ≥1.0% in the
Double-Blind, Controlled Clinical Trials with OSPHENA vs. Placebo
|Ospemifene 60 mg
|Reproductive System and Breast Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Skin and Subcutaneous Tissue Disorders|
The following adverse reactions have been identified during post-approval use of ospemifene. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: allergic conditions including hypersensitivity, angioedema
Read the entire FDA prescribing information for Osphena (Ospemifene Tablets)
Additional Osphena Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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