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Osphena

Last reviewed on RxList: 7/2/2019
Osphena Side Effects Center

Last reviewed on RxList 7/2/2019

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. Side effects from the use of Osphena include:

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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Osphena Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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)

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Related Resources for Osphena

© 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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