Naproxen — uses, dosing, side effects & the brands that sell it · pharmaranks
Naproxen: uses, dosing, side effects & brands
Naproxen is a nonsteroidal anti-inflammatory drug sold in the U.S. under 6 brand and generic names, for juvenile arthritis, rheumatoid arthritis and back pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Nonsteroidal Anti-Inflammatory Drug
Treats
Juvenile Arthritis, Rheumatoid Arthritis and Back Pain
From the FDA label for Naproxen (application ANDA074190). Other naproxen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dose for shortest duration consistent with individual patient treatment goals. ( 2 ) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen Oral Suspension 250 mg (10 mL) or 375 mg (15 mL) or 500 mg (20 mL) twice daily twice daily twice daily The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. The following table may be used as a guide for dosing of naproxen suspension: Patient’s Weight Dose Administered as 13 kg (29 lb) 62.5 mg twice daily 2.5 mL (1/2 tsp) twice daily 25 kg (55 lb) 125 mg twice daily 5.0 mL (1 tsp) twice daily 38 kg (84 lb) 187.5 mg twice daily 7.5 mL (1 1/2 tsp) twice daily Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of naproxen oral suspension is 500 mg (20 mL), followed by 250 mg (10 mL) every 6 to 8 hours as required. Acute Gout The recommended starting dose is 750 mg (30 mL) of naproxen oral suspension followed by 250 mg (10 mL) every 8 hours until the attack has subsided. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of naproxen…
Naproxen side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 )] • GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Hypertension [see Warnings and Precautions ( 5.4 )] • Heart Failure and Edema [see Warnings and Precautions ( 5.5 )] • Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6 )] • Anaphylactic Reactions [see Warnings and Precautions ( 5.7 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.9 )] • Hematologic Toxicity [see Warnings and Precautions ( 5.12 )] Most common adverse reactions to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed…
Every naproxen product we track (6)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
The elimination half-life of naproxen is about 12 to 17 hours. This is naproxen's elimination (terminal) half-life in healthy adults; its metabolites have shorter half-lives, so there is no longer-acting active metabolite to account for. The half-life is prolonged in severe renal impairment, and above 500 mg/day the drug shows nonlinear (dose-dependent) kinetics because plasma protein binding becomes saturated.
Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Frequently asked questions
What is naproxen?
Naproxen Oral Suspension, USP is available as a light orange suspension which readily resuspends on shaking containing 125 mg/5 mL of naproxen, USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is ( S )-2-(6-Methoxy-naphth-2-yl) propionic acid (2S)-2-(6-Methoxynaphthalen-2-yl)propanoic acid. The molecular weight is 230.26. Its molecular formula is C 14 H 14 O 3 , and it has the following chemical structure. Naproxen, USP is a white to off-white crystalline powder. It is practically insoluble in water and soluble in alcohol and in methanol. Naproxen Oral Suspension, USP for oral administration contains the following inactive ingredients: FD&C Yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, orange flavor, pineapple flavor, purified water, sodium chloride, sorbitol solution, and sucrose. It has a sodium content of 39.3 mg/5 mL, 1.71 mEq/5 mL, with a pH range of 2.2 to 3.7. naproxen-chem.jpg
What kind of drug is naproxen?
The FDA classifies naproxen as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does naproxen stay in your system?
The elimination half-life of naproxen is about 12 to 17 hours — that is how long the body takes to clear half of a dose. This is naproxen's elimination (terminal) half-life in healthy adults; its metabolites have shorter half-lives, so there is no longer-acting active metabolite to account for. The half-life is prolonged in severe renal impairment, and above 500 mg/day the drug shows nonlinear (dose-dependent) kinetics because plasma protein binding becomes saturated. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take naproxen with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run naproxen against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take naproxen
Naproxen oral suspension is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 )] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 )] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 )] • Known hypersensitivity to naproxen or any components of the drug product ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) • In the setting of CABG surgery ( 4 )
Naproxen drug interactions
See Table 1 for clinically significant drug interactions with naproxen. Table 1: Clinically Significant Drug Interactions with Naproxen. 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. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of naproxen oral suspension with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions ( 5.12 )] . Aspirin Clinical Impact: A pharmacodynamic (PD) study has demonstrated an interaction in which lower dose naproxen (220mg/day or 220mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, with the interaction most marked during the washout period of naproxen [see Clinical Pharmacology ( 12.2 )]. There is reason to expect that the interaction would…
We track 6 naproxen-containing products in the U.S.: Naproxen, Aleve, Ec-Naprosyn, Naprelan, Naprosyn and Naproxen Sodium. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does naproxen come in?
Across the brands we track, naproxen is currently marketed as suspension, tablet, tablet, delayed release, capsule and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic naproxen?
Yes. Our catalog lists 2 generic naproxen products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has naproxen been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions naproxen. The most recent: NAPROXEN ORAL SUSPENSION (Apr 20, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.