1 What is Osphena?

Brand: Osphena

Generic: Ospemifene

Osphena is an estrogen receptor modulator used for the treatment of women with moderate to severe dyspareunia that is due to menopause.

Vulvar and vaginal areas can have atrophy and dryness due to low estrogen levels. This drug works like natural estrogen in the body. This drug requires a prescription.

Have a question aboutEstrogen Replacement Therapy?Ask a doctor now

2 What to Know Before Using

Before using Osphena, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. This drug is contraindicated for use in the pediatric population.

  • Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of ospemifene.
  • Fetal abnormalities have been reported in studies of pregnant women or animals.
  • This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.
  • Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Abiraterone
  • Amiodarone
  • Bupropion
  • Ceritinib
  • Clarithromycin
  • Crizotinib
  • Dabrafenib
  • Eliglustat
  • Eslicarbazepine Acetate
  • Fentanyl
  • Fluconazole
  • Fluvoxamine
  • Idelalisib
  • Ketoconazole
  • Nilotinib
  • Piperaquine
  • Regorafenib
  • Amobarbital
  • Aprobarbital
  • Bosentan
  • Butabarbital
  • Butalbital
  • Carbamazepine
  • Dexamethasone
  • Efavirenz
  • Enzalutamide
  • Etravirine
  • Fosphenytoin
  • Mephobarbital
  • Methohexital
  • Modafinil
  • Nafcillin
  • Nevirapine
  • Oxcarbazepine
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Prednisone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Secobarbital
  • St John's Wort
  • or Thiopental

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

To use Osphena properly, you must follow all instructions given by your doctor. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. You can take this drug with food. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. 

Adults with dyspareunia are given 60 milligrams once a day. Use in children is not recommended. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Osphena, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Postmenopausal women are unlikely to become pregnant. It is important to note that this drug has teratogenic potential. Inform your healthcare professional immediately if you think you have become pregnant while using the drug.

The risk of blood clots, strokes, or heart attacks can be increased by this drug. The risk is even higher if you have high blood pressure, high cholesterol, or diabetes, or are overweight or smoke tobacco.

Contact your healthcare professional immediately if you have chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move the arms, legs or facial muscle, or an inability to speak.

The risk for endometrial or uterine cancer may be increased by this drug. Check with your healthcare professional immediately if you have abnormal vaginal bleeding.

Notify any health care professional who treats you that you are using this drug. You may need to stop using this drug before you have surgery or if you need to stay in bed for a long time.

Check with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Osphena. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • change in vaginal discharge
  • pain or feeling of pressure in the pelvis
  • vaginal bleeding
  • anxiety
  • chest pain
  • confusion
  • cough
  • difficulty with speaking
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • pain, redness, or swelling in the arm or leg
  • slow speech
  • sudden shortness of breath or troubled breathing
  • chest discomfort
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • shortness of breath
  • sweating, or vomiting

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.