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Ospemifene Side Effects

In Summary

More frequently reported side effects include: endometrial hyperplasia and hot flash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ospemifene: oral tablet

Along with its needed effects, ospemifene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ospemifene:

More Common

Less Common

  • 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

Rare

  • Chest discomfort
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • shortness of breath
  • sweating
  • vomiting

Some side effects of ospemifene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Feeling of warmth
  • increased sweating
  • redness of the face, neck, arms, and occasionally, upper chest

Less Common

  • Muscle spasms
  • white or brownish vaginal discharge

For Healthcare Professionals

Applies to ospemifene: oral tablet

Cardiovascular

Common (1% to 10%): Hot flashes

Uncommon (0.1% to 1%): Hemorrhagic stroke, deep vein thrombosis

Rare (less than 0.1%): Thromboembolic stroke, myocardial infarction[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis

Postmarketing reports: Rash, rash erythematous, rash generalized, pruritus, urticaria[Ref]

Genitourinary

Common (1% to 10%): Vaginal discharge, genital discharge, proliferative endometrium, endometrial thickening

Uncommon (0.1% to 1%): Uterine polyps

Rare (less than 0.1%): Simple hyperplasia without atypia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms[Ref]

Hypersensitivity

Postmarketing reports: Allergic conditions including hypersensitivity, angioedema

References

1. "Product Information. Osphena (ospemifene)." Shionogi USA Inc, Florham Park, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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