FREQUENTLY ASKED QUESTIONS

You and your patients have questions about Aleve®.
We have answers.

You and your patients have questions about Aleve®. We have answers.

 

 

 

 

 

 

Cardiovascular

Dental

Dysmenorrhea

First-line Treatment for Acute Pain

Gastrointestinal

General

Liver

NSAID Allergy Alert

Renal

 

 

CARDIOVASCULAR

The labeling for Aleve® is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling and includes a warning designed to inform consumers that “when using this product, the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.”1

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    References

    1. Aleve® Label.

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    DENTAL

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      How effective is Aleve® for dental pain?

      Aleve has a body of evidence supporting its use in the temporary relief of minor aches and pains including dental pain.1 Data supporting Aleve's use has been reviewed and approved by the FDA since 1994. In addition, a single dose of Aleve has been shown to be equally efficacious* as a single dose of a commonly used opioid in dental pain.2 See section below for details.

      *In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), HYD+APAP (10 mg + 650 mg), or placebo. Aleve® is indicated for minor aches and pains.2,3

      How effective is Aleve® at treating dental pain when compared with hydrocodone plus acetaminophen (HYD+APAP), a widely prescribed opioid in the United States?

      In a single-center, randomized, double-blind, parallel, placebo-controlled dental pain study, a single dose of Aleve®, a non-opioid OTC NSAID, was as effective as a single dose of HYD+APAP at hours 0 to 4 at reducing pain intensity (based on Sum of Pain Intensity Difference from 0 to 4 hours, or SPID0-4).2

      Aleve® is indicated for temporary relief of minor aches and pains

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      References

      1. Kiersch TA, Halladay SC, Hormel PC. A single-dose, double-blind comparison of naproxen sodium, acetaminophen, and placebo in postoperative dental pain. Clin Ther. 1994;16(3):394-404.

      2. Cooper SA, Desjardins PJ, Bertoch T, et al. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2021. doi:10.1080/00325481.2021.2008180.

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      DYSMENORRHEA

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        How long does Aleve® provide pain relief from primary dysmenorrhea when compared with Tylenol® Extra Strength?

        In a double-blind, randomized, single-dose, crossover dysmenorrhea study, Aleve provided significantly more pain relief over a 12 hour period than acetaminophen extra strength and significantly more subjects rated Aleve as good-to-excellent for pain relief versus acetaminophen extra strength.1 Based on the FDA approved Drug Facts Label, Aleve is dosed every 8-12 hours, Tylenol Extra Strength is dosed every 6 hours.

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        References

        1. Daniels, S. E., Paredes-Diaz, A., An, R., Centofanti, R., & Tajaddini, A. (2019). Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Current Medical Research and Opinion, 35(12), 2139-2147. https://doi.org/10.1080/03007995.2019.1654987

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        FIRST-LINE TREATMENT FOR ACUTE PAIN

        Many professional organizations recommend NSAIDs like naproxen sodium, the active ingredient in ALEVE®, as a first-line treatment for acute pain. Some of these organizations include:

        • American Dental Association
        • American Association of Oral and Maxillofacial Surgeons
        • American College of Gynecology
        • American Academy of Orthopaedic Surgeons
        • American College of Rheumatology
        • Osteoarthritis Research Society International
        • American College of Physicians

        To view the full recommendations, visit each organization’s website.

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          What data are available regarding naproxen sodium versus opioids for treatment of acute pain?

          For more information on safety and efficacy data regarding naproxen sodium and specific opioids studied, see the following selected references. These are not intended to be a comprehensive review of the literature.

          - Brunton S, Weisman S. (2019) Efficacy and Safety of Naproxen vs Opioids for the Treatment of Musculoskeletal Pain. Journal of Family Practice.

          - Cattry E, Troullos E, Paredes-Diaz A. (2020) Efficacy and safety of naproxen sodium 440 mg versus acetaminophen 600 mg/codeine phosphate 60 mg in the treatment of postoperative dental pain. American Journal of Dentistry.

           

          GASTROINTESTINAL

          The labeling for Aleve® is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling and a “Stomach Bleeding Warning” designed to inform consumers that the product contains an NSAID, which “may cause severe stomach bleeding.”1

          • The warning informs consumers that the risk of stomach bleeding is higher if: they are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others), have three or more alcoholic drinks every day while using the product, or take more or for a longer time than directed.1
          • Consumers are advised to ask a doctor before use if: the stomach bleeding warning applies to them or if they have a history of stomach problems such as heartburn.1
          • Consumers are advised to stop use and ask a doctor if: they experience any of the following signs of stomach bleeding, including feeling faint, vomiting blood, bloody or black stools, or stomach pain that does not get better.1

          The risk of GI bleeding with NSAID use is dose-dependent on and impacted by the duration of use.2 The minimum effective dose for the shortest duration of NSAID use is generally recommended to minimize undesirable effects including GI side effects.

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            What data are available regarding naproxen sodium and GI safety?

            Naproxen has been marketed for more than 40 years as a prescription product and naproxen sodium for more than 20 years as an over the counter product. It has been used by millions of people around the world, and when taken as directed, it is a safe and effective pain reliever.3

            A meta-analysis of 46 randomized, controlled studies demonstrated that the incidence of patient-reported GI adverse events (nausea and dyspepsia, were the most commonly reported) with OTC naproxen sodium was comparable to placebo.3

            In 1 long-term study (1 year in length) with naproxen at OTC doses (up to or equal to 440 mg a day), there was no significant difference between naproxen sodium and placebo in the incidence of gastrointestinal adverse events.4

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

            • Aisen PS, et al. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: A randomized controlled trial. JAMA. 2003.
            • Bansal V, et al. A look at the safety profile of over-the-counter naproxen sodium: A meta-analysis. J Clin Pharmacol. 2001.
            • Biskupiak JE, et al. Gastrointestinal complications of over-the-counter nonsteroidal anti-inflammatory drugs. J Pain Palliat Care Pharmacother. 2006.
            • Bombardier C, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000.
            • Castellsague J, et al. Individual NSAIDs and upper gastrointestinal complications: A systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012.
            • DeArmond B, et al. Safety profile of over-the-counter naproxen sodium. Clin Ther. 1995.
            • Dikman A, et al. A randomized, placebo-controlled study of the effects of naproxen, aspirin, celecoxib or clopidogrel on gastroduodenal mucosal healing. Aliment Pharmacol Ther. 2009.
            • Lewis JD, et al. Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005.
            • Massó González EL, et al. Variability among nonsteroidal antiinflammatory drugs in risk of upper gastrointestinal bleeding. Arthritis Rheum. 2010.
            • Mellemkjaer L, et al. Upper gastrointestinal bleeding among users of NSAIDs: A population-based cohort study in Denmark. Br J Clin Pharmacol. 2002.
            • Niculescu L, et al. Pooled analysis of GI tolerability of 21 randomized controlled trials of celecoxib and nonselective NSAIDs. Curr Med Res Opin. 2009.
            • Rahme E, et al. Hospitalization for gastrointestinal adverse events attributable to the use of low-dose aspirin among patients 50 years or older also using non-steroidal anti-inflammatory drugs: A retrospective cohort study. Aliment Pharmacol Ther. 2007.
            • Schnitzer TJ, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: Randomised controlled trial. Lancet. 2004.
            • Zhang W, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008.
            Aleve tablet

            References 

            1. Aleve® label. 

            2. Tarone RE, Blot WJ, McLaughlin JK. Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: Relative and absolute risk estimates from recent epidemiologic studies. Am J Ther. 2004;11(1):17-25. doi:10.1097/00045391-200401000-00003

            3. Bansal V, Dex T, Proskin H, et al. A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J Clin Pharmacol. 2001;41(2):127–138. doi:10.1177/00912700122009935

            4. Data on file.

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            If you have additional questions that are not answered here, or in other sections of the FAQ portion of the website, please feel free to contact us.

             

            GENERAL

            Below are general questions and answers about the ingredients and dosing of Aleve®. If you have additional questions that are not answered here, please feel free to contact us.

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              When was Aleve® approved for OTC use?

              In 1994, the FDA approved naproxen sodium, a prescription non-steroidal anti-inflammatory drug (NSAID), for marketing as a non-prescription pain reliever. ALEVE® is approved for use as 220 mg naproxen sodium per tablet, caplet, gelcap, or liquid gel.

              What are the active and inactive ingredients in Aleve®?

              The active ingredient contained in all Aleve® products is 220 mg of naproxen sodium per tablet (200 mg naproxen, 20 mg sodium).

              The inactive ingredients in Aleve® Tablets and Caplets are: FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

              The inactive ingredients in Aleve® Gelcaps are: D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc and titanium dioxide.

              The inactive ingredients in Aleve® Liquid Gels are: FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan and sorbitol.

              What is the OTC recommended dosage for Aleve®?

              It is recommended that adults and children ages 12 years and older take 1 caplet every 8 to 12 hours while symptoms last. For the first dose, patients may take 2 caplets within the first hour, but should not exceed two caplets in any 8- to 12-hour period, nor should they exceed 3 caplets in any 24-hour period. It is recommended that patients drink a full glass of water with each dose. The smallest effective dose should be utilized for the shortest duration possible.

              If you have additional questions that are not answered here, or in other sections of the FAQ portion of the website, please feel free to contact us.

               

              LIVER

              The labeling for Aleve® is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling and contains a warning for patients with liver cirrhosis to consult with their doctors before use.1

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                What data are available regarding naproxen/naproxen sodium and hepatic safety?

                Little data exist for naproxen sodium at OTC doses, but serious or life-threatening hepatic (i.e., liver) adverse events are very rare when naproxen sodium is taken as directed. Severe hepatic reactions, including jaundice, hepatitis and biliary adverse events, have been reported with the use of NSAIDs, including naproxen sodium, but such cases are very rare (less than 0.01% combined reporting rate from clinical trial data). In patients with severe hepatic impairment, dose reduction may be necessary.2  

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

                • Lapeyre-Mestre M, et al. Non-steroidal anti-inflammatory drug-related hepatic damage in France and Spain: Analysis from national spontaneous reporting systems. Fundam Clin Pharmacol. 2006.
                • Rostom A, et al. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: A systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol. 2005.
                • Soni P, et al. The hepatic safety and tolerability of the cyclooxygenase-2 selective NSAID celecoxib: pooled analysis of 41 randomized controlled trials. Curr Med Res Opin. 2009.
                Aleve tablet

                References 

                1. ALEVE® label. 

                2. Data on file.

                Aleve tablet

                If you have additional questions that are not answered here, or in other sections of the FAQ portion of the website, please feel free to contact us.

                 

                NSAID ALLERGY ALERT

                The labeling for Aleve® is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling with regards to the "Allergy Alert" and states that naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash and blisters.1

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                  Which patients are at an increased risk for experiencing allergic reactions to naproxen/naproxen sodium?

                  Hypersensitivity reactions may occur both in individuals with and without a history of hypersensitivity to aspirin exposure, other pain relievers/fever reducers or naproxen-containing products. Patients with known hypersensitivity to naproxen or any other ingredient in the product, or who have a history of asthma, rash, or allergic-type reactions after taking aspirin or other pain relievers/fever reducers, should not use naproxen-containing products, including Aleve®.2

                  Aleve tablet

                  References 

                  1. Aleve® label.

                  2. Data on file.

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                  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

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                    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 1,697 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 risk of decline in renal function.3

                    What data are available on naproxen/naproxen sodium for patients with preexisting 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.
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                    References 

                    1. Aleve® label. 

                    2. Data on file.

                    3. Curhan GC et al. Lifetime nonnarcotic analgesic use and decline in renal function in women. Arch Intern Med. 2004;164:1519-1524. doi:10.1001/archinte.164.14.1519

                    Aleve tablet

                    If you have additional questions that are not answered here, or in other sections of the FAQ portion of the website, please feel free to contact us.