Does Evista (raloxifene) cause renal stones?

Does Raloxifene (Evista) Cause Renal Stones?

No, there is no evidence that raloxifene (Evista) causes renal stones. Based on available guidelines and clinical evidence, renal stones are not listed among the known adverse effects of raloxifene therapy.

Known Side Effects of Raloxifene

Raloxifene is a selective estrogen receptor modulator (SERM) commonly used for:

• Prevention and treatment of osteoporosis in postmenopausal women 1
• Reduction of invasive breast cancer risk 1

The documented side effects of raloxifene include:

• Hot flashes and leg cramps 1
• Influenza-like syndromes 1
• Peripheral edema 1
• Increased risk of venous thromboembolism (0.7% for women receiving 60 mg/day raloxifene vs. 0.2% for placebo) 1
• Increased risk of pulmonary emboli (0.3% for women receiving 120 mg/day raloxifene vs. 0.1% for placebo) 1

Absence of Renal Stone Association

None of the major clinical trials or guidelines on raloxifene mention kidney stones as an adverse effect:

• The Multiple Outcomes of Raloxifene Evaluation (MORE) trial and its extension, the Continuing Outcomes Relevant to Evista (CORE) trial, which followed patients for up to 8 years, did not report renal stones as an adverse event 1
• The American College of Physicians guidelines on osteoporosis treatment do not list renal stones as a side effect of raloxifene 1
• The American Society of Clinical Oncology guidelines on breast cancer risk reduction medications do not mention renal stones as a concern with raloxifene 1

Raloxifene in Patients with Kidney Disease

Studies examining raloxifene in patients with chronic kidney disease (CKD) have not reported increased risk of renal stones:

• A study of raloxifene in postmenopausal women with CKD found no significant difference in adverse events between raloxifene and placebo groups across different categories of kidney function 2
• A systematic review of raloxifene in postmenopausal women with end-stage renal disease reported no side effects in the raloxifene group (0/121 patients) 3
• Another study showed that raloxifene may actually improve skeletal properties in an animal model of chronic kidney disease without mention of renal stone formation 4

Medications Known to Cause Renal Stones

For context, medications that are known to increase the risk of kidney stones include:

• Indinavir (an HIV protease inhibitor) 1
• Acyclovir, ciprofloxacin, foscarnet, and sulfonamides (through intratubular precipitation) 1
• Topiramate (an anticonvulsant that is sometimes used for migraine prevention) 1

Prevention of Kidney Stones

For patients concerned about kidney stones (regardless of medication use), general preventive measures include:

• Maintaining adequate fluid intake to achieve at least 2.5 liters of urine output daily 1
• Limiting dietary oxalate if oxalate stones are a concern 1
• Maintaining normal dietary calcium intake (rather than restricting it) 1

Conclusion

Based on the available evidence, raloxifene (Evista) has not been associated with an increased risk of renal stones. The documented adverse effects of raloxifene primarily include venous thromboembolic events, hot flashes, and leg cramps, but not kidney stones.