Raloxifene and Night Sweats
Yes, raloxifene can cause night sweats, particularly during the first 6 months of treatment. 1 Hot flashes and night sweats are recognized side effects of raloxifene therapy, though they tend to be mild to moderate in severity for most patients.
Vasomotor Symptoms Associated with Raloxifene
- Raloxifene (a Selective Estrogen Receptor Modulator or SERM) is FDA-approved for the prevention and treatment of osteoporosis in postmenopausal women and for reduction in risk of invasive breast cancer in postmenopausal women at high risk 2, 3
- Hot flashes and night sweats (collectively known as vasomotor symptoms) are common side effects associated with raloxifene treatment 2
- The FDA medication guide specifically lists hot flashes as a common side effect of raloxifene 3
- These symptoms are more pronounced during the first 6 months of therapy and may diminish over time 1
Incidence and Severity of Night Sweats
- In clinical studies, raloxifene increased the risk for hot flushes and leg cramps compared with placebo during the MORE trial 2
- Analysis of data from five randomized, placebo-controlled studies showed:
- Modest but statistically significant increase in hot flashes in raloxifene-treated patients (24.6%) compared to placebo (18.3%) 1
- This difference was only significant during the first 6 months of therapy (20.1% vs 14.4%) 1
- After 6 months, there was no statistically significant difference between treatment groups 1
- The majority (89%) of hot flashes in raloxifene-treated subjects were assessed as "mild-to-moderate" in severity 1
Risk Factors for Experiencing Night Sweats with Raloxifene
Certain patient characteristics are associated with a higher likelihood of experiencing vasomotor symptoms while on raloxifene:
- Younger postmenopausal women (under age 55) 1
- Women who had previously experienced hot flashes 1
- Women with a history of hysterectomy 1
- Women in early menopause 2
Other Important Side Effects of Raloxifene
While night sweats are a common side effect, other important adverse effects include:
- Increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) 2, 3
- Increased risk of fatal stroke in women with documented coronary heart disease or at increased risk for coronary events 3
- Leg cramps 2, 3
- Peripheral edema 2, 3
- Influenza-like syndromes 2
Clinical Implications
- For women experiencing significant menopausal symptoms, raloxifene may not be the optimal choice as it can exacerbate vasomotor symptoms 4
- Raloxifene should be discontinued at least 72 hours prior to prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest) due to increased risk of venous thromboembolic events 3
- Raloxifene is contraindicated in women with a history of venous thromboembolism 3
Comparison with Other Therapies
- Unlike estrogen therapy, raloxifene does not reduce hot flashes associated with estrogen deficiency 3
- When compared to tamoxifen (another SERM), raloxifene has a similar side effect profile regarding vasomotor symptoms 2
- Combined use of raloxifene with estrogen has been studied and showed reduced vasomotor symptoms compared to raloxifene alone, but this combination showed signs of endometrial stimulation and is not recommended outside clinical trials 5, 2
In summary, night sweats are a recognized side effect of raloxifene therapy, particularly during the first 6 months of treatment. Patients should be informed about this potential side effect before starting therapy, especially those with risk factors for experiencing vasomotor symptoms.