Side Effects of Daypro (oxaprozin)

Daypro (oxaprozin) is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

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

• rash,
• ringing in the ears,
• headaches,
• dizziness,
• drowsiness,
• abdominal pain,
• nausea,
• diarrhea,
• constipation,
• heartburn,
• 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.

Drug interactions of Daypro include lithium, because Daypro may increase the blood levels of lithium by reducing the excretion of lithium by the kidneys, which may lead to lithium toxicity.

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.

Taking Daypro during the last three months of pregnancy may harm a fetus and interfere with normal labor/delivery. Tell your doctor if you are pregnant or plan to become pregnant.

It is unknown if Daypro is excreted in breast milk. Consult your doctor before breastfeeding. 

The most common side effects from oxaprozin are

• rash,
• ringing in the ears,
• headaches,
• dizziness,
• drowsiness,
• abdominal pain,
• nausea,
• diarrhea,
• constipation,
• heartburn,
• 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.

Sometimes, stomach ulceration and intestinal bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding.

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.

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

• Cardiovascular Thrombotic Events
• GI Bleeding, Ulceration and Perforation
• Hepatotoxicity
• Hypertension
• 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.

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.

See Table 2 for clinically significant drug interactions with oxaprozin.

Table 2: Clinically Significant Drug Interactions with Oxaprozin

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.