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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
Reference: 1. Aleve® Label.
Dental
Aleve® was more effective than acetaminophen plus codeine in relieving acute postoperative dental pain following wisdom teeth removal. Patients with moderate to severe pain following wisdom tooth extraction receiving Aleve® 440 mg (two 220 mg capsules) versus acetaminophen plus codeine phosphate 660 mg/60 mg (two 300 mg/30 mg capsules) reported significantly reduced pain.
Aleve® is clinically proven to last longer than Tylenol® Extra Strength. Patients taking Tylenol® Extra Strength required remedication after as soon as 3 hours, and there was no significant difference in pain relief between Tylenol® Extra Strength and placebo at 6 hours.
Aleve® is significantly more effective on tough dental pain than Tylenol® Extra Strength. Three times more patients reported the overall effectiveness of Aleve® as very good or excellent versus Tylenol® Extra Strength.
In a recent single-center, randomized, double-blind, parallel, placebo-controlled 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).1
In a single-dose, clinical study, Aleve® had better tolerability than HYD+APAP, with fewer reported adverse events.1
- More treatment-related adverse events were reported with HYD+APAP (n=18) than Aleve® (n=1), including nausea, vomiting, and dizziness1
Reference: 1. 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.
Dysmenorrhea
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.
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.
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. 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;41:127-138. 4. Data on file. Bayer HealthCare LLC. 5. Aisen PS, Schafer KA, Grundman M, et al. Effects of rofecoxib or naproxen vs placebo on alzheimer disease progression: A randomized controlled trial. JAMA. 2003;289:2819-2826.
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.
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
References: 1. ALEVE® label. 2. Data on file. Bayer HealthCare LLC.
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
References: 1. Aleve® label. 2. Data on file.
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
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.
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.