Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Celecoxib is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat acute pain and menstrual cramps.

This medicine is available only with your doctor's prescription.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

If you cannot swallow the capsule, you may open it and pour the medicine to a teaspoon of cool or room temperature applesauce. This mixture must be swallowed right away without chewing and followed with a glass of water to make sure all of the mixture is swallowed.

Any medicine that has been mixed with applesauce may be stored in a refrigerator and used within 6 hours.

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:

More common

Cough

fever

skin rash

sneezing

sore throat

swelling of the face, fingers, feet, or lower legs

Less common or rare

Abnormal growth in the breast

arm, back, or jaw pain

bloody or black, tarry stools

blurred vision

burning feeling in the chest or stomach

burning or stinging of the skin

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

chest pain or discomfort

chest tightness or heaviness

chills

confusion

congestion in the chest

cramps

diarrhea

dry mouth

earache

fast or irregular heartbeat

heartburn

heavy bleeding

heavy non-menstrual vaginal bleeding

high blood pressure

increased hunger

increased thirst

increased urination

loss of appetite

loss of consciousness

muscle aches and pains

nausea

nerve pain

painful blisters on the trunk of body

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

redness or swelling in the ear

sensation of pins and needles

soreness or redness around the fingernails and toenails

stabbing pain

stiff neck

stomachache

stomach pain (severe)

sweating

tenderness in the stomach area

troubled breathing with exertion

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain

vomiting

vomiting of blood or material that looks like coffee grounds

weakness

wheezing

Incidence not known

Area rash

changes in skin color

clay-colored stools

dilated neck veins

light-colored stools

pale or a bluish color skin of the fingers or toes

seizures

slurred speech

sores, welting, or blisters

sudden and severe inability to speak

unpleasant breath odor

weakness in the arm or leg on one side of the body

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Continuing thirst

dizziness

drowsiness

headache, severe or continuing

shortness of breath

sudden decrease in the amount of urine

troubled breathing

weight gain

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:

More common

Back pain

gas

headache

heartburn

inability to sleep

pain or burning in the throat

stuffy or runny nose

Less common

Anxiety

bleeding after defecation

bloody or cloudy urine

breast pain

bone deformity

buzzing or ringing noise in the ears

change in sense of taste

constipation

decrease in height

decreased appetite

depression

difficult, burning, or painful urination

difficulty with moving or walking

difficulty with swallowing

excessive muscle tone, muscle tension, or tightness

excessive tearing

feeling of pressure

hair loss

hives

hoarseness

increased sweating

infection

inflammation

itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

itching of the vagina or genital area

joint or muscle pain or stiffness

large, flat, blue, or purplish patches in the skin

loss of energy or weakness

loss of hearing

muscle pain increased

muscle stiffness

nervousness

numbness or tingling in the fingers or toes

pain during sexual intercourse

pain in the back, ribs, arms, or legs

pounding heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness or swelling in the arms or legs

sensitivity of the skin to sunlight

severe sunburn

sleepiness

straining while passing stool

sudden sweating and feelings of warmth

swelling

swelling or inflammation of the mouth

tenderness

thick, white vaginal discharge with no odor or with a mild odor

thinning of the hair

trouble with swallowing

troubled breathing

uncomfortable swelling around anus

unexplained weight loss

voice changes

warmth on the skin

weakness or heaviness of the legs

Incidence not known

Bleeding gums

blistering, peeling, or loosening of the skin

bloating

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of sense of smell

pain

pinpoint red spots on the skin

red or irritated eyes

red skin lesions, often with a purple center

shakiness and unsteady walk

sores, ulcers, or white spots in the mouth or on the lips

stomach cramps

swelling of the neck

tenderness

trembling, or other problems with muscle control or coordination

unsteadiness

watery or bloody diarrhea

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.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise 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.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you or your child have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (such as steroids or a blood thinner).

Using this medication in certain patients under the age of 18 for the treatment of juvenile rheumatoid arthritis may increase the risk of disseminated intravascular coagulation (bleeding problem). Talk with your doctor if you have concerns about this .

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Taking two or more of the nonsteroidal anti-inflammatory drugs (NSAIDs) together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor tells you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow eyes and skin. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Celecoxib may 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, other nonsteroidal anti-inflammatory drugs (NSAIDs), or sulfonamide-type drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, 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. Ask someone to drive you to the nearest hospital emergency room. If this is not possible, do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug 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.