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Does Daypro (oxaprozin) cause side effects?
NSAIDs work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Daypro blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain and fever are reduced.
Common side effects of Daypro include
- ringing in the ears,
- abdominal pain,
- fluid retention, and
- shortness of breath.
Serious side effects of include
- increased bleeding after an injury,
- bleeding in the stomach and intestine,
- ulcers (signs include black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding),
- impaired kidney function,
- blood clots,
- heart attacks,
- high blood pressure (hypertension), and
- heart failure.
Daypro may reduce the blood pressure lowering effects of blood pressure medications.
- When Daypro is used in combination with methotrexate or aminoglycoside antibiotics the blood levels of those drugs may increase, presumably because their elimination is reduced. This may lead to more side effects from methotrexate or aminoglycoside.
- Individuals taking oral blood thinners or anticoagulants should avoid Daypro because Daypro also thins the blood, and excessive blood thinning may lead to bleeding. Daypro increases the negative effect of cyclosporine on kidney function.
- If aspirin is taken with Daypro there may be an increased risk for developing an ulcer.
- Persons who have more than 3 alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking Daypro or other NSAIDs.
What are the important side effects of Daypro (oxaprozin)?
The most common side effects from oxaprozin are
- ringing in the ears,
- abdominal pain,
- fluid retention, and
- shortness of breath.
NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury. Oxaprozin also may cause bleeding in the stomach and intestine as well as ulcers.
People who are allergic to other NSAIDs should not use oxaprozin. NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.
Individuals with asthma are more likely to experience allergic reactions to oxaprozin and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure also have been associated with the use of NSAIDs.
Daypro (oxaprozin) side effects list for healthcare professionals
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic Reactions
- Serious Skin Reactions
- Hematologic Toxicity
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 reaction data were derived from patients who received Daypro in multidose, controlled, and open-label clinical trials.
- Rates for events from clinical trial experience are based on 2253 patients who took 1200 mg to 1800 mg Daypro per day in clinical trials.
- Of these, 1721 patients were treated for at least 1 month, 971 patients for at least 3 months, and 366 patients for more than 1 year.
Incidence Greater Than 1%
In clinical trials of Daypro or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%.
Cardiovascular system: edema.
Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.
Hematologic system: anemia, increased bleeding time.
Skin and appendages: pruritus, rash.
Special senses: tinnitus.
Urogenital system: abnormal renal function, dysuria or frequency.
Incidence Greater Than 1%
The following adverse reactions were reported in clinical trials or in patients taking other NSAIDs.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including liver failure, stomatitis, hemorrhoidal or rectal bleeding.
The following adverse reactions have been identified during post approval use of Daypro. 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.
Body as a whole: serum sickness.
Hematologic system: agranulocytosis, pancytopenia.
Urogenital: acute interstitial nephritis, nephrotic syndrome, acute renal failure.
What drugs interact with Daypro (oxaprozin)?
See Table 2 for clinically significant drug interactions with oxaprozin.
Table 2: Clinically Significant Drug Interactions with Oxaprozin
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Daypro with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding.|
|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.|
|Intervention:||Concomitant use of Daypro and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.|
Daypro 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 Daypro with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The concomitant use of oxaprozin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Daypro 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 Daypro 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) because NSAID administration may result in increased plasma levels of methotrexate, especially in patients receiving high doses of methotrexate.|
|Intervention:||During concomitant use of Daypro and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Daypro and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Daypro and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of oxaprozin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of oxaprozin with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Daypro and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Daypro 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.
|Clinical Impact:||Concomitant use of corticosteroids with Daypro may increase the risk of GI ulceration or bleeding.|
|Intervention:||Monitor patients with concomitant use of Daypro with corticosteroids for signs of bleeding.|
|Clinical Impact:||While oxaprozin does alter the pharmacokinetics of glyburide, coadministration of oxaprozin to type II non-insulin dependent diabetic patients did not affect the area under the glucose concentration curve nor the magnitude or duration of control.|
|Intervention:||During concomitant use of Daypro and glyburide, monitor patient’s blood glucose in the beginning phase of cotherapy.|
Laboratory Test Interactions
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking Daypro. This is due to lack of specificity of the screening tests.
False-positive test results may be expected for several days following discontinuation of Daypro therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish Daypro from benzodiazepines.
Daypro (oxaprozin) is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Common side effects of Daypro include rash, ringing in the ears, headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea, constipation, heartburn, fluid retention, and shortness of breath. Taking Daypro during the last 3 months of pregnancy may harm a fetus and interfere with normal labor/delivery. It is unknown if Daypro is excreted in breast milk.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.