Oxaprozin (Oral route)
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Oxaprozin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .
Propionic Acid (class)
Uses of This Medicine:
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxaprozin in children 6 to 16 years of age. Safety and efficacy have not been established in children younger than 6 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxaprozin in the elderly. However, elderly patients may be more sensitive to the effects of oxaprozin than younger adults, and are more likely to have age-related heart, stomach, or kidney problems, which may require an adjustment in the dose of patients receiving oxaprozin.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Bismuth Subsalicylate
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Dabigatran Etexilate
- Ethacrynic Acid
- Flufenamic Acid
- Magnesium Salicylate
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Pentosan Polysulfate Sodium
- Phenyl Salicylate
- Protein C
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
- Trolamine Salicylate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Bleeding problems or
- Congestive heart failure or
- Edema (fluid retention or swelling) or
- Heart attack, history of or
- Heart or blood vessel disease or
- Hyperkalemia (high levels of potassium in the blood) or
- Hypertension (high blood pressure) or
- Kidney disease or
- Liver disease (eg, hepatitis) or
- Stomach or intestinal ulcers or bleeding, history of or
- Stroke, history of—Use with caution. This medicine may make these conditions worse. .
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of—Should not be used in patients with these conditions.
- Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
Proper Use of This Medicine:
Use this medicine exactly as ordered by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than ordered by your doctor. Using too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not break, crush, divide, or chew it.
When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For osteoarthritis and rheumatoid arthritis:
- Adults—1200 milligrams (mg) (two 600-mg tablets) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1800 mg per day, taken in divided doses.
- For juvenile rheumatoid arthritis:
- Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For osteoarthritis and rheumatoid arthritis:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your or your child's progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing or speaking, headache, nausea, unusual sweating, or faintness.
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).
Check with your doctor right away if you or your child has any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child has blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine. .
Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.
This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.
Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different medicine before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Skin rash
- Less common
- bloody or black, tarry stools
- burning upper abdominal or stomach pain
- burning while urinating
- cloudy urine
- decrease in urine output or decrease in urine-concentrating ability
- difficult or painful urination
- frequent urination
- itching skin
- loss of appetite
- nausea or vomiting
- pale skin
- severe abdominal or stomach pain, cramping, or burning
- severe and continuing nausea
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight loss
- bleeding gums
- blistering, peeling, or loosening of the skin
- blurred vision
- body aches or pain
- burning feeling in chest or stomach
- changes in blood pressure
- chest pain
- clay-colored stools
- cough or hoarseness
- cracks in the skin
- dark urine
- difficult or labored breathing
- difficulty swallowing
- dilated neck veins
- ear congestion
- extreme fatigue
- feeling of discomfort
- fever or chills
- fluid-filled skin blisters
- high fever
- hives or welts
- increased sensitivity of the skin to sunlight
- increased thirst
- increased volume of pale, dilute urine
- inflammation of the joints
- irregular, fast or slow, or shallow breathing
- joint or muscle pain
- large, flat, blue or purplish patches in the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of heat from the body
- loss of voice
- lower back or side pain
- muscle aches
- muscle twitching
- noisy breathing
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- pale or blue lips, fingernails, or skin
- pinpoint red or purple spots on the skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- redness or other discoloration of the skin
- redness, swelling, or soreness of tongue
- scaly skin
- severe sunburn
- skin thinness
- slow, fast, irregular, pounding, or racing heartbeat or pulse
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stuffy or runny nose
- swelling of the face, fingers, feet, or lower legs
- swelling or inflammation of the mouth
- swollen lymph glands
- tenderness in the stomach area
- tightness in the chest
- unpleasant breath odor
- upper right abdominal or stomach pain
- yellow eyes or skin
- More common
- Acid or sour stomach
- stomach discomfort
- Less common
- Continuing ringing or buzzing or other unexplained noise in the ears
- excess air or gas in the stomach or intestines
- hearing loss
- passing gas
- relaxed and calm
- sleepiness or unusual drowsiness
- trouble sleeping
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, dry, or itching eyes
- change in taste
- decreased hearing
- discharge, excessive tearing
- dry mouth
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- lack or loss of strength
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- sensation of spinning
- shakiness in the legs, arms, hands, feet
- trembling or shaking of the hands or feet
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017