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Naprosyn, Anaprox, Anaprox DS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events (see WARNINGS)
- GI Bleeding, Ulceration and Perforation (see WARNINGS)
- Hepatotoxicity (see WARNINGS)
- Hypertension (see WARNINGS)
- Heart Failure and Edema (see WARNINGS)
- Renal Toxicity and Hyperkalemia (see WARNINGS)
- Anaphylactic Reactions (see WARNINGS)
- Serious Skin Reactions (see WARNINGS)
- Hematologic Toxicity (see WARNINGS)
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 (see CLINICAL PHARMACOLOGY).
In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, 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 are:
Special Senses: tinnitus*, visual disturbances, hearing disturbances
Cardiovascular: edema*, palpitations
General: dyspnea*, thirst
In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.
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 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)
Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper or lower gastrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
Respiratory: eosinophilic pneumonitis, asthma
Dermatologic: alopecia, urticaria, skin rashes, 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
Reproduction (female): infertility
In patients taking NSAIDs, the following adverse experiences have also been reported in < 1% of patients.
Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death
Hepatobiliary: hepatitis, liver failure
Metabolic and Nutritional: weight changes
Respiratory: asthma, respiratory depression, pneumonia
Dermatologic: exfoliative dermatitis
Special Senses: blurred vision, conjunctivitis
*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.
Read the Naprosyn, Anaprox, Anaprox DS (naproxen) Side Effects Center for a complete guide to possible side effects
See Table 1 for clinically significant drug interactions with naproxen.
Table 1: Clinically Significant Drug Interactions with
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS 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; Hematologic Toxicity).|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS; Gastrointestinal Bleeding, Ulceration and Perforation).|
|Intervention:||Concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see WARNINGS; Hematologic Toxicity). NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|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. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention||During concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects (see WARNINGS; Renal Toxicity and Hyperkalemia).|
|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 NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and digoxin, monitor serum digoxin levels.|
|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%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy (see WARNINGS; Gastrointestinal Bleeding, Ulceration and Perforation).|
|Intervention:||The concomitant use of naproxen with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of NAPROSYN, EC-NAPROSYN, ANAPROX or ANAPROX DS and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. 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. In the absence of data regarding 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 following pemetrexed administration.|
|Antacids and Sucralfate|
|Clinical Impact:||Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.|
|Intervention:||Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with NAPROSYN EC-NAPROSYN, ANAPROX or ANAPROX DS is not recommended. Due to the gastric pH elevating effects of H2-blockers, sucralfate and intensive antacid therapy, concomitant administration of EC-NAPROSYN is not recommended.|
|Clinical Impact:||Concomitant administration of cholestyramine can delay the absorption of naproxen.|
|Intervention:||Concomitant administration of cholestyramine with NAPROSYN EC-NAPROSYN, ANAPROX or ANAPROX DS is not recommended.|
|Clinical Impact:||Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.|
|Intervention:||Patients simultaneously receiving NAPROSYN EC-NAPROSYN, ANAPROX or ANAPROX DS and probenecid should be observed for adjustment of dose if required.|
|Other albumin-bound drugs|
|Clinical Impact:||Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin.|
|Intervention:||Patients simultaneously receiving NAPROSYN EC-NAPROSYN, ANAPROX or ANAPROX DS and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.|
|Drug/Laboratory Test Interactions|
|Clinical Impact:||Naproxen may decrease platelet aggregation and prolong bleeding time.|
|Intervention:||This effect should be kept in mind when bleeding times are determined.|
|Clinical Impact:||The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay.|
|Intervention:||Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.|
|Urinary assays of 5-hydroxy indoleacetic acid (5HIAA)|
|Clinical Impact:||Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).|
|Intervention:||This effect should be kept in mind when urinary 5-hydroxy indoleacetic acid is determined.|
Read the Naprosyn, Anaprox, Anaprox DS Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/26/2016
Additional Naprosyn, Anaprox, Anaprox DS Information
- Naprosyn, Anaprox, Anaprox DS Drug Interactions Center: naproxen oral
- Naprosyn, Anaprox, Anaprox DS Side Effects Center
- Naprosyn, Anaprox, Anaprox DS in detail including Side Effects and Drug Images
- Naprosyn, Anaprox, Anaprox DS Overview including Precautions
- Naprosyn, Anaprox, Anaprox DS FDA Approved Prescribing Information including Dosage
Naprosyn, Anaprox, Anaprox DS - User Reviews
Naprosyn, Anaprox, Anaprox DS User Reviews
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