Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Tramadol is an opioid pain medicine.

Celecoxib and tramadol is a combination medicine used in adults for the management of pain when other medicines cannot be used or have not worked.

Celecoxib and tramadol may also be used for purposes not listed in this medication guide.

Celecoxib and tramadol can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Celecoxib and tramadol may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

You should not use celecoxib and tramadol if you are allergic to it, or if you have:

• an allergy to sulfa drugs or opioids;
• severe asthma, trouble breathing, or other breathing problems;
• a bowel blockage or narrowing of the stomach or intestines; or
• a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not give celecoxib and tramadol to people:

• younger than 12 years or younger than 18 years after surgery to remove the tonsils and/or adenoids.

Avoid giving celecoxib and tramadol to people 12 to 18 years who have sleep apnea, obesity, or other breathing problems.

Do not use celecoxib and tramadol if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you have ever had:

• head injury or seizures;
• thyroid problems;
• problems urinating;
• pancreas or gallbladder problems;
• a stomach ulcer, bleeding in your stomach or intestines;
• heart disease, high blood pressure;
• asthma;
• drug or alcohol addiction, opioid overdose, or mental health problems; or
• liver or kidney disease.

You should not take celecoxib and tramadol unless your doctor tells you to. If you use celecoxib and tramadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Taking this medicine during the last 20 weeks of pregnancy may harm an unborn baby. Tell your doctor if you become pregnant or think that you may be pregnant.

Do not breastfeed while using celecoxib and tramadol.

Use Celecoxib And Tramadol (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, 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).

Stop using celecoxib and tramadol and seek medical treatment right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Stop using celecoxib and tramadol and seek medical treatment right away if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Celecoxib and tramadol can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears, or severe constipation;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
• 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, leg swelling, feeling short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Stop using celecoxib and tramadol and call your doctor at once if you have:

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• heart problems--swelling, rapid weight gain, feeling short of breath.

Common side effects may include nausea, vomiting, dizziness, headache, and drowsiness.

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.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you.