Prescription and over-the-counter medicine
Naproxen Brand names: Aleve, Naprelan, Bayer, Rugby; first approved as Naprosyn
Naproxen (Aleve) is a prescription and over-the-counter medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 139 generic labelers, and pharmacies paid $0.0565 per naproxen 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the naproxen FDA label on DailyMed (effective March 12, 2026, Bayer HealthCare LLC.); the NDA 17581 record on Drugs@FDA; every naproxen label on DailyMed.
Highlights of the record
FDA label of March 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS.
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions ( 5.1 ) ].
Naproxen tablets and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. […]
This box is printed on the prescription label of naproxen; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usagetemporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Forms and strengths
- 200 mg
- 220 mg
- 250 mg
- 275 mg
- 375 mg
- 500 mg
- 550 mg
- 750 mg
- 25 mg/ml
- 125 mg/5ml
Tablet; film-coated tablet; coated tablet; liquid-filled capsule; film-coated extended-release tablet.
On the market
- Earliest approval on file
- March 11, 1976 Naprosyn, Atnahs Pharma Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 74 first October 30, 1992; 35 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 160 of which 139 under generic applications, 28 under brand applications, repackagers included
- Last listed patent
- March 3, 2026 Naproxen Sodium capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0565 per tablet Naproxen 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest April 20, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 142,225 through July 30, 2026
What is naproxen used for?
From the label: indications and usagetemporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Conditions named in the indications of naproxen's FDA labels, with every medicine labeled for each:
From other naproxen labelsFever: Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Rheumatoid arthritis: For the relief of the signs and symptoms of rheumatoid arthritis
Osteoarthritis: For the relief of the signs and symptoms of osteoarthritis
Gout: For relief of the signs and symptoms of acute gout
Pain: For the management of pain
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Aleve Caplets), Bayer HealthCare LLC., effective March 12, 2026 (SPL set 02941928-128a-2c88-e063-6294a90ac6ba), via openFDA; the full label on DailyMed
What does the patient leaflet for naproxen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • older age • longer use of NSAIDs • poor health • smoking • advanced liver disease • drinking alcohol • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed
Source: FDA drug label (Naproxen Sodium), Glenmark Pharmaceuticals Inc., USA, effective December 23, 2025 (SPL set 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9), via openFDA; the full label on DailyMed
Is there a generic for naproxen (Aleve)?
The FDA approved the first generic naproxen on October 30, 1992. 74 generic applications are approved; 35 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists naproxen from 139 labelers under a generic (ANDA) application and from 28 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Aleve tablets; a patent listed only for Naproxen Sodium capsules runs to March 3, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1976 earliest approval on file
- 1992 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naproxen (Aleve)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0565 per Naproxen 500 mg tablet, down 9% from $0.0619 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Naproxen 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| All day pain relief 220 mg tablet | Generic | $0.0673 per tablet | $2.02 | +2% |
| All day pain rlf 220 mg caplet | Generic | $0.0673 per unit | n/a | +2% |
| All day relief 220 mg caplet | Generic | $0.0673 per unit | n/a | +2% |
| All day relief 220 mg tablet | Generic | $0.0673 per tablet | $2.02 | +2% |
| Ft all day pain 220 mg caplet | Generic | $0.0673 per unit | n/a | +2% |
| Ft naproxen sodium 220 mg capsule | Generic | $0.149 per capsule | $4.48 | +5% |
| Gnp naproxen sod 220 mg caplet | Generic | $0.0673 per unit | n/a | +2% |
| Gnp naproxen sod 220 mg tablet | Generic | $0.0673 per tablet | $2.02 | +2% |
| Gnp naproxen sodium 220 mg capsule | Generic | $0.149 per capsule | $4.48 | +5% |
| Gs naproxen sod 220 mg caplet | Generic | $0.0673 per unit | n/a | +2% |
| Gs naproxen sod 220 mg tablet | Generic | $0.0673 per tablet | $2.02 | +2% |
| Naproxen 125 mg/5 mL suspen | Generic | $0.202 per mL | n/a | -13% |
| Naproxen 250 mg tablet | Generic | $0.0436 per tablet | $1.31 | -4% |
| Naproxen 375 mg tablet | Generic | $0.0588 per tablet | $1.77 | +0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naproxen been recalled?
The FDA's Enforcement Report lists 9 recalls naming naproxen since 2012: 0 Class I (the most serious), 9 Class II, 0 Class III; 4 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of naproxen and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 20, 2026 | Class II | Acella Pharmaceuticals, LLC | Chemical contamination; presence of lead and lithium above specification |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| November 7, 2023 | Class II | Glenmark Pharmaceuticals Inc., USA | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen |
| August 27, 2021 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| August 11, 2021 | Class II | Granules USA, Inc. | CGMP Deviations |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP … |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| July 6, 2012 | Class II | Glenmark Generics Inc., USA | Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the naproxen label say about other medicines?
The naproxen label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name naproxen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications (prescription label) | History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cholestyramine | drug interactions (prescription label) | Clinical Impact: Concomitant administration of cholestyramine can delay the absorption of naproxen. Intervention: Concomitant administration of cholestyramine with naproxen tablets or naproxen sodium tablets is not recommended. |
| Cyclosporine | drug interactions (prescription label) | Clinical Impact: Concomitant use of naproxen tablets or naproxen sodium tablets and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions (prescription label) | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions (prescription label) | NSAIDs and Salicylates Clinical Impact: Concomitant use of naproxen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions () ]. Intervention: The concomitant use of naproxen with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions (prescription label) | Clinical Impact: The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions (prescription label) | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including … |
| Indomethacin | drug interactions (prescription label) | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions (prescription label) | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets and lithium, monitor patients for signs of lithium toxicity. |
| Magnesium oxide | drug interactions (prescription label) | Clinical Impact: Concomitant administration of some antacids (…) and sucralfate can delay the absorption of naproxen. Intervention: Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen tablets and naproxen sodium tablets is not recommended. |
| Meloxicam | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of naproxen tablets and naproxen sodium tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions (prescription label) | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets and methotrexate, monitor patients for methotrexate toxicity. |
| Nabumetone | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of naproxen tablets and naproxen sodium tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of naproxen tablets and naproxen sodium tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of naproxen tablets and naproxen sodium tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for … |
Every other medicine the naproxen label names
| Medicine named | Section | What the label says |
|---|---|---|
| Probenecid | drug interactions (prescription label) | Clinical Impact: Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. Intervention: Patients simultaneously receiving naproxen tablets or naproxen sodium tablets and probenecid should be observed for adjustment of dose if required. Other albumin-bound drugs |
| Propranolol | drug interactions (prescription label) | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: • During concomitant use of naproxen tablets or naproxen sodium tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
| Sucralfate | drug interactions (prescription label) | Antacids and Sucralfate Clinical Impact: Concomitant administration of some antacids (…) and sucralfate can delay the absorption of naproxen. Intervention: Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen tablets and naproxen sodium tablets is not recommended. |
| Warfarin | drug interactions (prescription label) | Drugs That Interfere with Hemostasis Clinical Impact: • Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of naproxen tablets or naproxen sodium tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors … |
Other labels that name naproxen
Source: FDA drug label (Aleve Caplets), Bayer HealthCare LLC., effective March 12, 2026 (SPL set 02941928-128a-2c88-e063-6294a90ac6ba), via openFDA; the full label on DailyMed
What do FAERS reports show for naproxen?
The FDA Adverse Event Reporting System holds 142,225 reports that list naproxen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,473 are coded as a death and 36,252 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as naproxen?
32 other medicines are given the same way (oral) and in the same FDA class as naproxen or labeled mainly for the same use (fever), the same class first. Fever lists all 8 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis, Cough and cold, Fever | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Celecoxib | Pain, Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain, Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain, Cough and cold, Fever | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain, Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does naproxen compare with medicines for the same use?
22 side-by-side pages set naproxen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to naproxen
- 32 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Naproxen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other