Naproxen is an active pharmaceutical ingredient in the Propionic Acid Derivatives group (M01AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised September 20, 2024[1]
Adults:
Naproxen is used in the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), acute musculoskeletal disorders, Ankylosing spondylitis, dysmenorrhoea, and acute gout.
Children:
Naproxen is effective in the treatment of juvenile rheumatoid arthritis in children over 5 years of age.
How to take
USUnited States· FDA
48 products
Uses
USOfficial regulatory label· revised January 29, 2026[2]
1 INDICATIONS AND USAGE Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea
CACanada· Health Canada
34 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
APO-NAPROXEN (naproxen) is indicated for: • The treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. • The relief of minor aches and pains in muscles, bones and joints, mild to moderate pain accompanied by inflammation in musculoskeletal injuries (sprains and strains) and primary dysmenorrhea.
, enteric coated and sustained release) are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed. For patients with an increased risk of developing cardiovascular and/or gastrointestinal adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first.
See
How to take
Drug interactions
Known interactions involving Naproxen. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL521040019 · revised September 20, 2024
[2]FDA DailyMed · 000155a8-709c-44… · revised January 29, 2026 [PDF]
[3]Health Canada (DPD) · 00522651 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised September 20, 2024[1]
4).
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis 500mg to 1g taken in 2 doses at 12-hour intervals or alternatively, as a single administration. In the following cases a loading dose of 750mg or 1g per day for the acute phase is recommended: a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another anti- rheumatic compound. c) In osteoarthrosis where pain is the predominant symptom. Acute gout In acute gout, an initial dose of 750 mg followed by 250 mg every 8 hours until the attack has passed.
Acute musculoskeletal disorders and dysmenorrhoea The recommended dose is 500 mg initially followed by 250 mg at 6-8 hour intervals as needed, with a maximum daily dose after the first day of 1250 mg.
Paediatric population For juvenile rheumatoid arthritis:
A dose of 10 mg per kg body weight daily in two divided doses taken in children at 12-hour intervals over 5 years of age with juvenile rheumatoid arthritis. Naproxen is not recommended for use in any other indication in children under 16 years of age.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. The patient should be monitored regularly for GI bleeding during NSAID therapy. Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly.
The implication of this finding for naproxen dosing is unknown. As with other drugs used in the elderly it is prudent to use the lowest effective dose and for the shortest duration possible as older people are more prone to adverse events.
For the effect of reduced elimination in the elderly refer to Section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised September 20, 2024[1]
The following adverse events have been reported with NSAIDs and with naproxen Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress.
4), oesophagitis, gastritis and pancreatitis.
Blood and lymphatic system disorders:
Neutropenia, thrombocytopenia, granulocytopenia including agranulocytosis, eosinophilia, leucopenia, aplastic anaemia and haemolytic anaemia.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reactions to NSAIDs. These may consist of (a) nonspecific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angio-oedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Metabolic and nutrition disorders: hyperkalaemia.
Psychiatric disorders:
Insomnia, dream abnormalities, depression, confusion and hallucinations.
Nervous system disorders:
Convulsions, dizziness, headache, lightheadedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and cognitive dysfunction have been reported. 4).
Eye Disorders:
Visual disturbances, corneal opacity, papillitis and papilloedema.
Ear and Labyrinth disorders:
Tinnitus, hearing disturbances including impairment and vertigo.
Cardiac disorders:
Oedema, palpitations, cardiac failure and congestive heart failure have been reported. 4).
Vascular disorders:
Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea, asthma, eosinophilic pneumonitis and pulmonary oedema.
Hepatobiliary disorders:
Jaundice, fatal hepatitis and abnormal liver function tests.
Skin and subcutaneous tissue disorders:
Skin rashes including, itching (pruritus), urticaria, ecchymoses, purpura, sweating. Alopecia, erythema multiforme, Stevens Johnson syndrome, erythema nodosum, lichen planus, pustular reaction, SLE, epidermal necrolysis, very rarely toxic epidermal necrolysis, photosensitivity reactions (including cases in which skin resembles porphyria cutanea tarda “pseudoporphyria”) or epidermolysis bullosa-like reactions which may occur rarely.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored. 4).
Musculoskeletal and connective tissue disorders:
Myalgia and muscle weakness.
Renal and urinary disorders:
Including, but not limited to, glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal papillary necrosis and renal failure.
Reproductive system and breast disorders:
Female infertility.
General disorders and administration site conditions:
Thirst, pyrexia, fatigue and malaise.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised September 20, 2024[1]
4. Renal/hepatic impairment A reduction in dosage may be necessary if there is impaired renal or hepatic function. 4). 3). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Method of administration For oral administration, preferably with or after food.
1. • Patients with active gastrointestinal bleeding. • Active or history of recurrent peptic ulceration / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, nasal polyps, angioedema or urticaria).
Since the potential exists for cross-sensitivity reactions, in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
4) . • A history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 6). 2, and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
Older people and/or debilitated patients are particularly susceptible to the adverse effects of NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Prolonged use of NSAIDs in these patients is not recommended.
Where prolonged therapy is required, patients should be reviewed regularly. The antipyretic and anti-inflammatory activities of Naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs. Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
As with other non-steroidal anti-inflammatory drugs, elevations of one or more liver function tests may occur. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti- inflammatory drugs.
Cross reactivity has been reported. Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking Naproxen.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised September 20, 2024[1]
1. • Patients with active gastrointestinal bleeding. • Active or history of recurrent peptic ulceration / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, nasal polyps, angioedema or urticaria).
Since the potential exists for cross-sensitivity reactions, in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
4) . • A history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 6).
This is not medical advice. Consult a qualified healthcare professional.
How to take
USOfficial regulatory label· revised January 29, 2026[2]
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. 1 ) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen tablets 250 mg (one-half tablet) 500 mg twice daily Naproxen sodium tablets 275 mg (one-half tablet) 550 mg 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 Naproxen tablets may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis.
A liquid formulation may be more appropriate. Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms. Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis Recommended starting dose 550 mg of naproxen sodium as naproxen sodium tablets followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required.
The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired.
Acute Gout Recommended starting dose 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided. Naproxen sodium tablets may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours. 1 General Dosing Instructions Carefully consider the potential benefits and risks of naproxen tablets and naproxen sodium tablets and other treatment options before deciding to use naproxen tablets and naproxen sodium tablets.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with naproxen tablets or naproxen sodium tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Naproxen-containing products such as naproxen and naproxen sodium tablets, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion. 2 Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis The recommended dosages of naproxen tablets and naproxen sodium tablets are shown in Table 1.
Table 1:
Recommended dosages for naproxen tablets and naproxen sodium tablets Naproxen tablets 250 mg (one half tablet) 500 mg twice daily Naproxen sodium tablets 275 mg (one half tablet) 550 mg (naproxen 500 mg with 50 mg sodium) twice daily During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient.
A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk.
3 Polyarticular Juvenile Idiopathic Arthritis Naproxen solid-oral dosage forms may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate for weight-based dosing and due to the need for dose flexibility in children.
In pediatric patients, doses of 5 mg/kg/day produced plasma levels of naproxen similar to those seen in adults taking 500 mg of naproxen [ see Clinical Pharmacology ( 12 ) ]. The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses.
Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms. 4 Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of naproxen sodium tablets is 550 mg followed by 550 mg every 12 hours or 275 mg (one half of a 550 mg tablet) every 6 to 8 hours as required.
The initial total daily dose should not exceed 1375 mg (two and one-half tablets) of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets is recommended for the management of acute painful conditions when prompt onset of pain relief is desired.
Naproxen tablets may also be used. The recommended starting dose of naproxen tablets is 500 mg followed by 250 mg (one half of a 500 mg naproxen tablet) every 6 to 8 hours as required. The total daily dose should not exceed 1250 mg of naproxen.
5 Acute Gout The recommended starting dose is 750 mg (one and one-half tablets) of naproxen tablets followed by 250 mg (one-half tablet) every 8 hours until the attack has subsided. Naproxen sodium tablets may also be used at a starting dose of 825 mg (one and one-half tablets) followed by 275 mg (one-half tablet) every 8 hours.
, tablets, suspension) of naproxen are not interchangeable. This difference should be taken into consideration when changing strengths or formulations.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 6,027 reports total. [4]
Off Label Use 928
Drug Ineffective 801
Pain 707
Fatigue 702
Nausea 698
Rash 668
Headache 650
Diarrhoea 625
Vomiting 620
Arthralgia 615
Dyspnoea 601
Wound 559
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 29, 2026[2]
12 ) ] Most common adverse reactions to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema. gov/medwatch. 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 below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea.
The most frequent complaints reported related to the gastrointestinal tract. A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen.
In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with polyarticular juvenile idiopathic arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were greater, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.
In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients were: Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura Special Senses: tinnitus*, visual disturbances, hearing disturbances Cardiovascular: edema*, palpitations General: dyspnea*, thirst *Incidence of reported reaction between 3% and 9%.
Those reactions occurring in less than 3% of the patients are unmarked. In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients. Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of naproxen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized. Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever) Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper or lower gastrointestinal tract.
Esophagitis, stomatitis, hematemesis, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease). Hepatobiliary: abnormal liver function tests, hepatitis (some cases have been fatal) Hemic and Lymphatic: eosinophilia, leucopenia, granulocytopenia, hemolytic anemia, aplastic anemia Metabolic and Nutritional: hyperglycemia, hypoglycemia Nervous System: depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions Respiratory: eosinophilic pneumonitis, asthma Dermatologic: alopecia, urticaria, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored. Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine Reproduction (female): infertility In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.
USOfficial regulatory label· Warnings and precautions· revised January 29, 2026[2]
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. 3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure. 4 , 7 ) Heart Failure and Edema: Avoid use of naproxen tablets and naproxen sodium tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. 5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of naproxen tablets and naproxen sodium tablets in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. 6 ) Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
7 ) Exacerbation of Asthma Related to Aspirin Sensitivity: Naproxen tablets and naproxen sodium tablets are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
8 ) Serious Skin Reactions : Discontinue naproxen tablets and naproxen sodium tablets at first appearance of skin rash or other signs of hypersensitivity. 10 ).
Fetal Toxicity:
Limit use of NSAIDs, including naproxen tablets and naproxen sodium tablets, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. 1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 29, 2026[2]
9 ) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. 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 )
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[3]
4 Geriatrics. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 5 of 53 2 CONTRAINDICATIONS APO-NAPROXEN is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although naproxen has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.
• the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition • women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants • severe uncontrolled heart failure • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
In addition, patients on 1500 mg/day need to be followed closely for the development of any adverse events. During long–term administration, the dose of APO-NAPROXEN may be adjusted up or down depending on the clinical response of the patient.
A lower dose may suffice for long–term administration. Patients with rheumatoid arthritis or osteoarthritis maintained on a dose of 750 or 1000 mg/day in divided doses can be switched to a once daily dose of APO-NAPROXEN SR 750 mg. The single daily dose of APO-NAPROXEN SR should not be exceeded and can be administered in the morning or evening.
Analgesia / Musculoskeletal Injuries The recommended dose for naproxen is 250 mg three times a day or 375 mg twice a day. This may be increased to 500 mg twice a day if needed. The lowest effective dose should be used. Dysmenorrhea The recommended starting dose for naproxen is two 250 mg tablets (or one 500 mg tablet), followed by one 250 mg tablet every 6 to 8 hours, as required.
The total daily dose should not exceed 5 tablets (1250 mg). Alternatively, one 500 mg tablet given twice daily may be used.
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use.
See 2 CONTRAINDICATIONS Geriatrics (>65 years of age):
In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary. 4 Geriatrics Renal impairment: A lower dose should be considered in patients with mild and moderate renal impairment.
5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored). See 2 CONTRAINDICATIONS APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 9 of 53 Hepatic impairment: A lower dose should be considered in patients with mild and moderate hepatic impairment.
APO-NAPROXEN is contraindicated in severe liver impairment or active liver disease. 4 Administration APO-NAPROXEN, APO-NAPROXEN SR and APO-NAPROXEN EC tablets should be swallowed whole. 5 Missed Dose If a dose is missed, the patient should take it as soon as it is recognized.
If it is almost time for the next dose, skip the missed dose and continue with the next scheduled dose. The patient should be instructed not take 2 doses at the same time. 5 OVERDOSAGE Frequently observed signs and symptoms of overdose are drowsiness, dizziness, disorientation, heartburn, indigestion, epigastric pain, abdominal discomfort, nausea, vomiting, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis and apnea.
A few patients have experienced convulsions, but it is not clear whether or not these were naproxen related. Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare.
Anaphylactoid reactions have been repeated with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes.
g. activated charcoal) may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, haemodialysis, or haemoperfusion may not be useful due to high protein binding.
For management of a suspected drug overdose, contact your regional poison control centre. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 10 of 53 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablets, 125 mg, 250 mg, 375 mg and 500 mg Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.
The 250 and the 500 mg tablets also contain D&C yellow #10 and FD&C yellow #6; the 375 mg tablets contain only FD&C yellow #6; the 125 mg tablets contain D&C yellow #10 and FD&C blue #2. Sustained-Release Tablets, 750 mg D&C yellow #10, FD&C yellow #6, hydroxypropyl methylcellulose and magnesium stearate.
Tablets: APO-NAPROXEN 125 mg tablets: Each pale green, oval, biconvex tablet engraved “APO-125” on one side, contains 125 mg naproxen. Available in bottles of 100 and 500 tablets.
APO-NAPROXEN 250 mg tablets:
Each yellow, oval, biconvex tablet engraved “APO-250” on one side contains 250 mg naproxen. Available in bottles of 100 and 1000 tablets. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 11 of 53 APO-NAPROXEN 375 mg tablets: Each peach-coloured, capsule- shaped, biconvex tablet, scored and engraved “APO 375” on one side, contains 375 mg naproxen.
Available in bottles of 100 and 500 tablets.
APO-NAPROXEN 500 mg tablets:
Each yellow, capsule-shaped, biconvex tablet, scored and engraved “APO 500” on one side, contains 500 mg naproxen. Available in bottles of 100 and 500 tablets.
Sustained-Release Tablets:
APO-NAPROXEN SR 750 mg tablets: Each peach, capsule-shaped, biconvex tablet, engraved “APO-750” on one side, contains 750 mg of naproxen. Available in bottles of 100 and 500 and unit dose packages of 100 (10 x 10).
Enteric-Coated Tablets:
APO-NAPROXEN EC 250 mg tablets: Each white, round, biconvex, enteric-coated tablet, engraved “APO” on one side, and “250” on the other side, contains 250 mg of naproxen. Available in bottles of 100 and 500 […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
1 Pregnant Women 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
9 5 OVERDOSAGE ................................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 10 7 WARNINGS AND PRECAUTIONS ....................................................................................
1 Special Populations .................................................................................................... 1 Pregnant Women .......................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[3]
1 Pregnant Women 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. 3), and in older people. These patients should commence treatment on the lowest dose available.
g. 5). Patients with a history of GI toxicity, particularly when older, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 5). When GI bleeding or ulceration occurs in patients receiving Naproxen, the treatment should be withdrawn.
8). Renal Effects There have been reports of impaired renal function, renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen. Renal failure linked to reduced prostaglandin production The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics, angiotensin converting enzyme inhibitors, angiotensin-II receptor antagonists and older people.
3). Use in patients with impaired renal function As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised and patients should be adequately hydrated.
Naproxen is contraindicated in patients having a baseline creatinine […]
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. 2 ) ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG [ see Contraindications ( 4 ) ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of naproxen tablets and naproxen sodium tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If naproxen tablets and naproxen sodium tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
2 Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including naproxen, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year.
However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding. Strategies to Minimize the GI Risks in NSAID-treated patients: • Use the lowest effective dosage for the shortest possible duration.
• Avoid administration of more than one NSAID at a time. • Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
• Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. • If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue naproxen tablets and naproxen sodium tablets until a serious GI adverse event is ruled out.
• In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [ see Drug Interactions ( 7 )]. 3 Hepatotoxicity Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials.
In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including naproxen.
, nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). ), discontinue naproxen tablets or naproxen sodium tablets immediately, and perform a clinical evaluation of the patient.
4 Hypertension NSAIDs, including naproxen tablets and naproxen sodium tablets, can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.
Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [ see Drug Interactions ( 7 ) ]. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
5 Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [ see Drug Interactions ( 7 ) ]. Avoid the use of naproxen tablets or naproxen sodium tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If naproxen tablets or naproxen sodium tablets is used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Since each naproxen sodium tablet contains 50 mg of sodium (about 2 mEq per each 500 mg of naproxen), this should be considered in patients whose overall intake of sodium must be severely restricted.
6 Renal Toxicity and Hyperkalemia Renal Toxicity Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. No information is available from controlled clinical studies regarding the use of naproxen tablets or naproxen sodium tablets in patients with advanced renal disease.
The renal effects of naproxen tablets or naproxen sodium tablets may hasten the progression of renal dysfunction in patients with preexisting renal disease. Correct volume status in dehydrated or hypovolemic patients prior to initiating naproxen tablets or naproxen sodium tablets.
Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of naproxen tablets and naproxen sodium tablets [ see Drug Interactions ( 7 ) ]. Avoid the use of naproxen tablets and naproxen sodium tablets in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.
If naproxen tablets or naproxen sodium tablets is used in patients with advanced renal disease, monitor patients for signs of worsening renal function. Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.
In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. 8 ) ]. Seek emergency help if an anaphylactic reaction occurs. 8 Exacerbation of Asthma Related to Aspirin Sensitivity A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs.
Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, naproxen tablets and naproxen sodium tablets are contraindicated in patients with this form of aspirin sensitivity [ see Contraindications ( 4 ) ].
When naproxen tablets or naproxen sodium tablets is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma. 9 Serious Skin Reactions NSAIDs, including naproxen, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of naproxen tablets or naproxen sodium tablets at the first appearance of skin rash or any other sign of hypersensitivity.
Naproxen tablets and naproxen sodium tablets are contraindicated in patients with previous serious skin reactions to NSAIDs [ see Contraindications ( 4 ) ]. 10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as naproxen tablets and naproxen sodium tablets.
Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue naproxen tablets and naproxen sodium tablets and evaluate the patient immediately. 11 Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs , including naproxen tablets and naproxen sodium tablets, in pregnant women at about 30 weeks of gestation and later.
NSAIDs, including naproxen tablets and naproxen sodium tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Oligohydramnios /Neonatal Renal Impairment Use of NSAIDs , including naproxen tablets and naproxen sodium tablets, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit naproxen tablets or naproxen sodium tablets use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if naproxen tablets or naproxen sodium tablets treatment extends beyond 48 hours.
1 )]. 12 Hematologic Toxicity Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with naproxen tablets or naproxen sodium tablets has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including naproxen tablets and naproxen sodium tablets, may increase the risk of bleeding events. , aspirin), serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.
Monitor these patients for signs of bleeding [ see Drug Interactions ( 7 )]. 13 Masking of Inflammation and Fever The pharmacological activity of naproxen tablets and naproxen sodium tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
6 ) ]. Patients with initial hemoglobin values of 10g or less who are to receive long-term therapy should have hemoglobin values determined periodically. Because of adverse eye findings in animal studies with drugs of this class, it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs.
7 Drug-Laboratory Test Interactions ............................................................................. 31 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 32 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 34 PART II: SCIENTIFIC INFORMATION ......................................................................................
35 13 PHARMACEUTICAL INFORMATION ................................................................................ 35 14 CLINICAL TRIALS ............................................................................................................