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Uses

See also Warning section.

This product is used to help relieve moderate to severe acute pain. It is for use by people who cannot take or who do not get pain relief from non-opioid analgesics (such as acetaminophen or ibuprofen).

This medication contains 2 ingredients: tramadol and celecoxib. Tramadol belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Celecoxib is known as a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor. It works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

Side Effects

See also Warning section.

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.

Warnings & Precautions

See also Warning section.

Before taking tramadol/celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (such as ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), brain disorders (such as head injury, tumor, seizures), breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD), diabetes, gallbladder disease, growths in the nose (nasal polyps), heart disease (such as heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, suicidal thoughts), disease of the pancreas (pancreatitis), stroke, thyroid disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal/esophagus problems (such as bleeding, blockage, constipation, ulcers), difficulty urinating (such as due to enlarged prostate).

Kidney problems can sometimes occur with the use of NSAID medications, including celecoxib. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this medication, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug for children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Get medical help right away if your child develops sudden bleeding/bruising or bluish skin on the fingers/toes.

Some children may be more sensitive to very serious side effects of this medication, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and QT prolongation (see above). Older adults may also be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke, and more likely to develop a type of salt imbalance (hyponatremia) while using this drug.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

This medication passes into breast milk and may have undesirable effects on a nursing infant (such as unusual sleepiness, difficulty feeding, or trouble breathing). Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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.

Does interact with other drugs you are taking?

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Overdose/Missed Dose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow/shallow breathing, slow/irregular heartbeat, coma, seizure, severe stomach pain, coffee ground-like vomit, change in amount of urine, severe headache, or loss of consciousness.