This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
- This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your doctor.
- This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.
- This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.
- This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
- This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may cause drowsiness or slowed actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with the doctor.
- Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
- Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
- This drug is not approved for use in children. Do not give to a child younger than 12 years of age. Children between 12 and 18 years of age who are very overweight or have certain other health problems like sleep apnea or other lung or breathing problems must not use this drug. If your child has been given this drug, ask the doctor for information about the benefits and risks.
- Some children have had very bad and sometimes deadly breathing problems when using tramadol after surgery to remove tonsils or adenoids. Do not give to a child younger than 18 years of age who has had surgery to remove tonsils or adenoids.
- It is used to ease pain.
- This drug must only be used when other drugs cannot be used or have not worked. If you have questions, talk with the doctor.
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
- If you have a sulfa allergy.
- If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
- If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
- If you have any of these health problems: Dehydration, GI (gastrointestinal) bleeding, heart failure (weak heart), kidney disease, or liver disease.
- If you have had a recent heart attack.
- If you have thoughts of suicide or if you have ever had alcohol or other drug abuse or dependence.
- If you have been told by your doctor that you are a slow or rapid metabolizer of some drugs.
- If you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
- If you are taking another drug that has the same drug in it.
- If you are taking any of these drugs: Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
- If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
- If you are taking any other drugs. Certain other drugs may interact with this drug and cause severe side effects, including deadly breathing problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you are having trouble getting pregnant or you are having your fertility checked.
- If you are pregnant, plan to become pregnant, or get pregnant while taking this drug. This drug may cause harm to an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this drug if your doctor has told you to. Do not take this drug if you are more than 30 weeks pregnant.
- If you are breast-feeding. Do not breast-feed while you take this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
- Rarely, bleeding in the brain that was deadly has happened with this drug. If you have questions, talk with the doctor.
- Low blood sugar has happened with this drug. Sometimes, people have had to go to the hospital. Call your doctor right away if you have signs of low blood sugar like dizziness, headache, feeling sleepy or weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
- The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
- The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
- A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
- Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period, or ejaculation problems.
- Taking an opioid drug like this drug may lead to a rare but severe adrenal gland problem. Call your doctor right away if you feel very tired or weak, you pass out, or you have severe dizziness, very upset stomach, throwing up, or decreased appetite.
- A severe and sometimes deadly reaction has happened with drugs like this one. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Rarely, some allergic reactions have been deadly.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
- Trouble breathing, slow breathing, or shallow breathing.
- Severe constipation or stomach pain. These may be signs of a severe bowel problem.
- Chest pain or pressure, a fast heartbeat, or an abnormal heartbeat.
- Noisy breathing.
- Breathing problems during sleep (sleep apnea).
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Flu-like signs.
- Swollen gland.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling dizzy, sleepy, tired, or weak.
- Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- Do not take this drug for longer than you were told by your doctor.
- Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
- If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
- Long-term or regular use of opioid drugs like this drug may lead to dependence. Lowering the dose or stopping this drug all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
- Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
- If you are taking aspirin to help prevent a heart attack, talk with your doctor.
- If you smoke, talk with your doctor.
- If you have asthma, talk with your doctor. You may be more sensitive to this drug.
- This drug may raise the chance of seizures. The chance may be higher in people who have certain health problems, use certain other drugs, or drink a lot of alcohol. Talk to your doctor to see if you have a greater chance of seizures while taking this drug.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- If you are 65 or older, use this drug with care. You could have more side effects.
- If you take this drug on a regular basis, take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
- Store at room temperature in a dry place. Do not store in a bathroom.
- Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider.
- A drug called naloxone can be used to help treat an overdose of this drug. Your doctor may order naloxone for you to keep with you while you take this drug. If you have questions about how to get or use naloxone, talk with your doctor or pharmacist. If you think there has been an overdose, get medical care right away even if naloxone has been used.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
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