Medical Editor: John P. Cunha, DO, FACOEP
What Is Daypro?
Daypro (oxaprozin) is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. Daypro is available in generic form.
What Are Side Effects of Daypro?
Daypro may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- sneezing,
- runny or stuffy nose,
- wheezing,
- fever,
- sore throat,
- burning eyes,
- skin pain,
- red or purple skin rash with blistering and peeling,
- chest pain spreading to your jaw or shoulder,
- sudden numbness,
- weakness on one side of the body,
- slurred speech,
- shortness of breath,
- skin rash (no matter how mild),
- swelling,
- rapid weight gain,
- bloody or tarry stools,
- coughing up blood,
- vomiting that looks coffee grounds,
- nausea,
- upper stomach pain,
- itching,
- tiredness,
- flu-like symptoms,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- little or no urination,
- swelling in your feet or ankles,
- pale skin,
- unusual tiredness,
- lightheadedness, and
- cold hands and feet
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Daypro include:
- upset stomach,
- constipation,
- diarrhea,
- nausea,
- vomiting,
- gas,
- heartburn,
- stomach pain,
- bloating,
- drowsiness,
- dizziness,
- fatigue,
- headache,
- nervousness,
- skin itching or rash,
- dry mouth,
- increased sweating,
- runny nose,
- blurred vision, or
- ringing in your ears
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Daypro
To treat rheumatoid arthritis and osteoarthritis, the usual recommended adult dose is 1200 mg (two 600-mg caplets) given orally once a day. Pediatric dose is determined by the child's weight.
What Drugs, Substances, or Supplements Interact with Daypro?
Daypro may interact with antidepressants, cyclosporine, lithium, blood thinners, steroids, aspirin or other NSAIDs. Tell your doctor all medications you use.
Daypro During Pregnancy or Breastfeeding
Daypro should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to a fetus and interference with normal labor/delivery. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Daypro (oxaprozin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See SlideshowGet emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing or difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using oxaprozin and call your doctor at once if you have:
- a skin rash, no matter how mild;
- heart problems--swelling, rapid weight gain, feeling short of breath;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
- nausea, upset stomach;
- diarrhea, constipation; or
- rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
The term arthritis refers to stiffness in the joints. See AnswerSIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
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.
Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.
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.
Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis.
Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including liver failure, stomatitis, hemorrhoidal or rectal bleeding.
Hematologic system: aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, purpura, thrombocytopenia, leukopenia.
Metabolic system: hyperglycemia, weight changes.
Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.
Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.
Skin: alopecia, angioedema, urticaria, photosensitivity, sweat.
Special senses: blurred vision, conjunctivitis, hearing decrease.
Urogenital: cystitis, hematuria, increase in menstrual flow, oliguria/ polyuria, proteinuria, renal insufficiency, decreased menstrual flow.
Postmarketing Experience
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.
Digestive system: hepatitis, pancreatitis.
Hematologic system: agranulocytosis, pancytopenia.
Skin: pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
Urogenital: acute interstitial nephritis, nephrotic syndrome, acute renal failure.
DRUG INTERACTIONS
See Table 2 for clinically significant drug interactions with oxaprozin [see CLINICAL PHARMACOLOGY].
Table 2: Clinically Significant Drug Interactions with Oxaprozin
| Drugs That Interfere with Hemostasis | |
| Clinical Impact: |
|
| 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 [see WARNINGS AND PRECAUTIONS]. |
| Aspirin | |
| 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 AND PRECAUTIONS]. |
| Intervention: | Concomitant use of DAYPRO and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. DAYPRO is not a substitute for low dose aspirin for cardiovascular protection. |
| ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
| Clinical Impact: |
|
| Intervention: |
|
| 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. 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 [see WARNINGS AND PRECAUTIONS]. |
| Digoxin | |
| 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. |
| Lithium | |
| 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. |
| Methotrexate | |
| 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. |
| Cyclosporine | |
| 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 [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | The concomitant use of oxaprozin with other NSAIDs or salicylates is not recommended. |
| Pemetrexed | |
| 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. |
| Corticosteroids | |
| 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 [see WARNINGS AND PRECAUTIONS]. |
| Glyburide | |
| 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.
Read the entire FDA prescribing information for Daypro (Oxaprozin Caplets)
© Daypro Patient Information is supplied by Cerner Multum, Inc. and Daypro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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