Frequently Asked Questions

Renal

The labeling for ALEVE is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling, which contains instructions for patients with kidney disease to consult with their doctor before use.1

What is the incidence of renal impairment with naproxen/naproxen sodium?

Renal impairment, although rare, can occur with the use of certain pain relievers. In clinical trials with naproxen/naproxen sodium, the incidence of renal impairment is rare, with a less than 0.1% combined reported rate.2

What data exist regarding the renal safety of naproxen/naproxen sodium?

There is limited data on renal safety with naproxen sodium at OTC doses. Based on a cohort study of OTC analgesic use among 1697 women who participated in the Nurses Health Study, the authors concluded that a higher lifetime use (>3000 g) of both aspirin and other NSAIDs is not associated with a decline in renal function.3

What data are available on naproxen/naproxen sodium for patients with pre-existing renal impairment?

Naproxen sodium at OTC doses has been shown to be safe and well tolerated, when used as directed.2 In patients with severe renal impairment, however, dose reduction may be necessary.2

For more information on the renal safety of naproxen/naproxen sodium see the following selected references. These are not intended to be a comprehensive review of the literature:

  • Curhan GC, et al. Lifetime nonnarcotic analgesic use and decline in renal function in women. Arch Intern Med. 2004.
  • Gooch K, et al. NSAID use and progression of chronic kidney disease. Am J Med. 2007.
  • Whelton A. Renal and related cardiovascular effects of conventional and COX-2-specific NSAIDs and non-NSAID analgesics. Am J Ther. 2000.
  • Winkelmayer WC, et al. Nonselective and cyclooxygenase-2-selective NSAIDs and acute kidney injury. Am J Med. 2008.

References: 
1. ALEVE label.
2. Data on file. Bayer HealthCare LLC.
3. Curhan GC et al. Lifetime nonnarcotic analgesic use and decline in renal function in women.  Arch Intern Med. 2004;164:1519-1524.
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