July 1, 2016
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Daypro

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Daypro




Daypro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/10/2016

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. 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.

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. Daypro may interact with antidepressants, cyclosporine, lithium, blood thinners, steroids, aspirin or other NSAIDs. Tell your doctor all medications you use. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Daypro in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking oxaprozin and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • dry mouth;
  • increased sweating, runny nose;
  • blurred vision; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Daypro (Oxaprozin Caplets)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Daypro Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Upset stomach, constipation, diarrhea, nausea, vomiting, gas, heartburn, drowsiness, dizziness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (such as ringing in the ears), mental/mood changes, persistent/severe headache, unexplained stiff neck, change in the amount of urine, easy bruising/bleeding, unusual tiredness.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Daypro (Oxaprozin Caplets)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Daypro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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 to 1800 mg DAYPRO per day in clinical trials. Of these, 1721 were treated for at least 1 month, 971 for at least 3 months, and 366 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 Less Than 1%

The following adverse reactions were reported in clinical trialsor 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, acuterenal failure.

Read the entire FDA prescribing information for Daypro (Oxaprozin Caplets)

Daypro - User Reviews

Daypro User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Daypro sorted by most helpful. Patient Discussions FAQs

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.


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