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Tramadol/celecoxib has a risk for abuse and addiction, which can lead to overdose and death. Tramadol/celecoxib may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of the medication that works and take it for the shortest possible time. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of tramadol/celecoxib from your body, which may affect how it works. Be sure you know how to take this medication and what other drugs you should avoid taking with it. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away. Nonsteroidal anti-inflammatory drugs (including celecoxib) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG). Also, celecoxib may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. Stop taking this medication and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight. Children younger than 12 years should not use this medication. Children between 12 and 18 years old should not use this medication after certain surgeries (including tonsil/adenoid removal). Also, this medication is not recommended for use by children between 12 and 18 years old who are obese or have breathing problems. Some children are more sensitive to the tramadol in this medication and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (). Talk with your doctor or pharmacist about the risks and benefits of this medication.

Nausea, vomiting, stomach upset, gas, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, hallucinations), severe stomach/abdominal pain, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss), pain/swelling/warmth in the groin/calf, signs of kidney problems (such as change in the amount of urine), difficulty urinating, difficult/painful swallowing, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, seizure. This medication may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. Tramadol is changed into a strong opioid drug in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion. 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: fever, swollen lymph nodes, 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Some products that may interact with this drug are: ACE inhibitors (such as captopril, lisinopril), aliskiren, angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, lithium, naltrexone, certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine), samidorphan, "water pills" (diuretics such as furosemide). This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as naproxen or ibuprofen). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Other medications can affect the removal of this medication from your body, which may affect how it works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), quinidine, rifamycins (such as rifampin), ritonavir, drugs used to treat seizures (such as carbamazepine), among others. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain lab tests (including amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.