Note: This document contains side effect information about ospemifene. Some dosage forms listed on this page may not apply to the brand name Osphena.
Summary
More frequent side effects include: endometrial hyperplasia and hot flash. Continue reading for a comprehensive list of adverse effects.
Applies to ospemifene: oral tablet.
Warning
Oral route (Tablet)
Endometrial CancerOspemifene is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, ospemifene has estrogen agonistic effects. There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular DisordersIn the clinical trials for ospemifene (duration of treatment up to 15 months) the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in the ospemifene 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the ospemifene 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. Ospemifene should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as a part of the Women's Health Initiative (WHI).
Serious side effects of Osphena
Along with its needed effects, ospemifene (the active ingredient contained in Osphena) 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:
Less common
- Vaginal bleeding
Incidence not known
- Anxiety
- change in vaginal discharge
- chest pain
- cough
- dizziness or lightheadedness
- fainting
- fast heartbeat
- fever
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- tightness in the chest
- troubled breathing or swallowing
Other side effects of Osphena
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
- redness of the face, neck, arms, and occasionally, upper chest
- sudden sweating
- white or brownish vaginal discharge
Less common
- Headache
- increased sweating
- muscle spasms
- night sweats
For Healthcare Professionals
Applies to ospemifene: oral tablet.
General
The more commonly reported adverse events have included hot flush, vaginal discharge, muscle spasms, genital discharge, and hyperhidrosis.
Cardiovascular
In the clinical trials, the incidence rates of thromboembolic and hemorrhagic stroke in women receiving this drug were 1.13 and 3.39 per thousand women years, compared with 3.15 and 0 per thousand women years in placebo. Two cases of myocardial infarction occurred in women receiving this drug and 2 cases of deep vein thrombosis.
This drug has been reported to initiate or increase the occurrence of hot flashes in some women. In phase 2/3 clinical trials, about 1% of women discontinue this drug due to hot flushes.[Ref]
Common (1% to 10%): Hot flashes
Uncommon (0.1% to 1%): Hemorrhagic stroke, deep vein thrombosis (DVT)
Rare (less than 0.1%): Thromboembolic stroke, myocardial infarction
Postmarketing reports: Thrombosis, pulmonary embolism[Ref]
Respiratory
Postmarketing reports: Pulmonary embolism
Oncologic
Postmarketing reports: Endometrial hyperplasia, endometrial cancer
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]
During clinical trials, one case of simple hyperplasia without atypia occurred. Endometrial thickening of 5 mm or greater was observed in women taking 60 mg/day at a rate of 60.1 per thousand compared to 21.2 per thousand in the placebo group. Any type of proliferative (weakly plus active plus disordered) endometrium was reported at 86.1 per thousand in women taking this drug compared with 13.3 per thousand for placebo. Uterine polyps occurred at an incidence of 5.9 per thousand compared with 1.8 per thousand in those receiving this drug and placebo, respectively. Endometrial cancer was not reported in trials up to 52 weeks long.[Ref]
Dermatologic
Common (1% to 10%): Hyperhidrosis
Postmarketing reports: Rash, rash erythematous, rash generalized, pruritus, urticaria[Ref]
Musculoskeletal
Common (1% to 10%): Muscle spasms[Ref]
Hypersensitivity
Postmarketing reports: Allergic conditions including hypersensitivity, angioedema
Nervous system
Postmarketing reports: Headache
