Medical Editor: John P. Cunha, DO, FACOEP
What Is Osphena?
Osphena (ospemifene) is an estrogen agonist/antagonist prescribed for painful intercourse (dyspareunia), which is a symptom of vulvar and vagina muscular wasting (vaginal atrophy), due to menopause.
What Are Side Effects of Osphena?
Side effects from the use of Osphena include:
- hot flashes,
- vaginal discharge,
- muscle spasms,
- increased or excessive sweating, and
- rash, itching, or hives.
Dosage for Osphena
The dose of Osphena is a 60 mg tablet, taken once daily with food.
What Drugs, Substances, or Supplements Interact with Osphena?
Osphena may interact with fluconazole (Diflucan), rifampin (Rifadin), and estrogens.
Osphena During Pregnancy or Breastfeeding
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.
Additional Information
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.
QUESTION
If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer3 pharmacies near 98837 have coupons for Osphena (Brand Names:Osphena for 30 Tablets)
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
- signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg; or
- any unusual vaginal bleeding.
Common side effects may include:
- vaginal discharge or heavy bleeding;
- hot flashes;
- headache;
- increased sweating, night sweats; or
- muscle spasm.
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.
SLIDESHOW
What Is Osteoporosis? Treatment, Symptoms, Medication See SlideshowSIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOX 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 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.
The incidence rates of thromboembolic and hemorrhagic stroke were 1.13 per thousand women years (1 reported case of thromboembolic stroke) and 3.39 per thousand women years (3 reported cases of hemorrhagic stroke), respectively in OSPHENA 60 mg treatment group and 3.15 (1 case of thromboembolic stroke) and 0 per thousand women years, respectively in placebo. There were 2 reported cases of DVT among the 1459 women in the OSPHENA 60 mg treatment group and 1 case of DVT among the 1136 women in the placebo group.
Table 1 lists adverse reactions occurring more frequently in the OSPHENA 60 mg treatment group than in placebo and at a frequency ≥1% in the 12-week, double-blind, placebo-controlled clinical trials. Table 2 lists adverse reactions occurring more frequently in the OSPHENA 60 mg treatment group than in placebo and at a frequency ≥1% in all clinical trials up to 52-weeks.
Table 1: Adverse Reactions Reported More Commonly in the OSPHENA Treatment Group (60 mg Once Daily) and at Frequency ≥1.0% in the 12 Week Double-Blind, Controlled Clinical Trials with OSPHENA vs. Placebo
| Ospemifene 60 mg (N=1459) % |
Placebo (N=1136) % |
|
| Vascular Disorders | ||
| Hot flush | 6.5 | 2.6 |
| Reproductive System and Breast Disorders | ||
| Vaginal discharge | 3.8 | 0.4 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Muscle spasms | 1.8 | 0.6 |
| Skin and Subcutaneous Tissue Disorders | ||
| Hyperhidrosis | 1.1 | 0.2 |
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)
| Ospemifene 60 mg All Trials (N=847) % |
Placebo (N=165) % |
|
| Nervous System Disorders | ||
| Headaches | 2.8 | 2.4 |
| Vascular Disorders | ||
| Hot flush | 12.2 | 4.2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Muscle spasms | 4.5 | 2.4 |
| Skin and Subcutaneous Tissue Disorders | ||
| Hyperhidrosis | 2.5 | 1.8 |
| Night sweats | 1.2 | 0.0 |
| Reproductive System and Breast Disorders | ||
| Vaginal discharge | 6.0 | 0.6 |
| Vaginal hemorrhage | 1.3 | 0.0 |
Postmarketing Experience
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.
Neoplasms Benign, Malignant and Unspecified (incl. cysts and polyps): endometrial hyperplasia, endometrial cancer
Immune System Disorders: allergic conditions including hypersensitivity, angioedema
Nervous System Disorders: headache
Vascular Disorders: deep vein thrombosis, thrombosis, pulmonary embolism
Skin and Subcutaneous Tissue Disorders: rash, rash erythematous, rash generalized, pruritus, urticaria
Read the entire FDA prescribing information for Osphena (Ospemifene Tablets)
© Osphena Patient Information is supplied by Cerner Multum, Inc. and Osphena Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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