Uses

What is tramadol/acetaminophen used for?

Tramadol/acetaminophen is commonly used to treat severe acute pain.

Tramadol/acetaminophen may also be used for other conditions as determined by your healthcare provider.

How does tramadol/acetaminophen work (mechanism of action)?

Tramadol/acetaminophen works to change how your body feels and responds to pain. Tramadol partly works similarly to an opioid medicine. Tramadol also works by increasing the amount of natural chemicals called serotonin and norepinephrine. Acetaminophen may work by blocking pain signals.

How is tramadol/acetaminophen supplied (dosage forms)?

Tramadol/acetaminophen is available as 37.5 mg/325 mg oral tablets that are taken by mouth.

How should I store tramadol/acetaminophen?

Tramadol/acetaminophen should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it.

Side Effects

What are the most common side effects of tramadol/acetaminophen?

The most common side effects of tramadol/acetaminophen are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Constipation or diarrhea
  • Nausea or vomiting  
  • Sleepiness or tiredness  
  • Loss of appetite
  • Headache
  • Dizziness
  • Stomach pain
  • Increased sweating 

There may be other side effects of tramadol/acetaminophen that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of tramadol/acetaminophen?

While less common, the most serious side effects of tramadol/acetaminophen are described below, along with what to do if they happen.

Severe Allergic Reactions. Tramadol/acetaminophen may cause allergic reactions, which can be serious. Stop taking tramadol/acetaminophen and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Risk of Misuse and Addiction. Misusing tramadol/acetaminophen can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take tramadol/acetaminophen exactly as prescribed. Tell your healthcare provider if you feel that tramadol/acetaminophen is not working. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

  • Sudden confusion or feeling disoriented
  • Feeling paranoid
  • Suicidal thoughts or actions
  • Seizures
  • Trouble breathing

Breathing Problems. Tramadol/acetaminophen may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your healthcare provider if you develop severe sleepiness or trouble breathing, especially when you start tramadol/acetaminophen or when your dose is increased. Get emergency help right away if you have any of the following symptoms.

  • Changes in the color of your skin, including bluish color to your lips and fingernails
  • Confusion
  • Shortness of breath
  • Feeling dizzy, lightheaded, or fainting
  • Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat 
  • Slow or shallow breathing
  • Excessive sleepiness or trouble staying awake

Increased Pain Sensitivity (Hyperalgesia). Tramadol/acetaminophen can cause an increased sensitivity to pain. It can cause things that normally cause pain to feel more painful than usual. Tramadol/acetaminophen can also cause allodynia. This happens when things that normally do not cause pain, such as wearing glasses or brushing your hair, become painful. If your pain increases, do not take extra doses of tramadol/acetaminophen. This could cause you to overdose or develop other serious side effects. Call your healthcare provider right away if your pain increases, you feel more sensitive to pain, or if you develop pain in other areas of the body. 

Liver Damage (Hepatotoxicity). Liver damage, also called hepatotoxicity, can happen when taking tramadol/acetaminophen. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Serotonin Syndrome. Serotonin syndrome is when there is too much of a substance called serotonin in your body. Tramadol/acetaminophen can cause serotonin syndrome when it is taken alone or with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help if you have any of the following symptoms of serotonin syndrome.

  • Sweating, fever, or flushing
  • Confusion
  • Feeling agitated or restless
  • Seeing or hearing unusual things
  • Dizziness
  • Fast or racing heartbeat
  • Nausea, vomiting, or diarrhea
  • Muscle twitching, stiffness, or tremor
  • Seizures

Seizures. Some people who have taken tramadol/acetaminophen have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking tramadol/acetaminophen and call your healthcare provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Suicidal Thoughts and Actions. Tramadol/acetaminophen may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt 
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Reduced Adrenal Function. Long-term use of tramadol/acetaminophen can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

Low Blood Pressure (Hypotension). Tramadol/acetaminophen may cause low blood pressure. If you feel faint or dizzy, lie down. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Feeling weak or tired

Severe Skin Reactions. Tramadol/acetaminophen can cause severe skin reactions called Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) that can lead to death if not treated. If you develop a rash, call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Sphincter of Oddi Spasm. The sphincter of Oddi is a muscular valve in your body that controls the flow of bile and digestive juices from the pancreas into the small intestine. When this valve spasms, it may feel like getting a tight muscle cramp, causing pain and blocking the flow of these juices, which can lead to discomfort and digestive problems. This is more likely to happen if you do not have a gallbladder. Stop taking tramadol/acetaminophen and get emergency medical help if you have new or worse stomach pain or pain in the upper right side of your stomach-area that travels to your back or shoulder, with or without nausea and vomiting. 

Low Sodium Level (Hyponatremia). Tramadol/acetaminophen may cause low sodium levels. Call your healthcare provider if you have any of the following symptoms of a low sodium level.

  • Headache
  • Drowsiness
  • Muscle weakness or cramps
  • Nausea, vomiting, or loss of appetite
  • Tiredness or sleepiness
  • Dizziness
  • Weight gain
  • Restlessness or irritability
  • Change in your mental condition such as hallucinations, confusion, decreased awareness, or alertness
  • Seizures

Low Blood Sugar (Hypoglycemia). Tramadol/acetaminophen can cause low blood sugar, which can be serious and may lead to death. You may need to check your blood sugar more often if you have changes to your diet, exercise regimen, or medicines for diabetes. Do not use tramadol/acetaminophen and call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.

  • Headache
  • Crankiness or anxiety
  • Hunger
  • Dizziness or confusion
  • Blurry vision
  • Slurred speech
  • Sweating
  • Feeling jittery or shakiness
  • Fast heartbeat
  • Seizures

Warnings & Precautions

Who should not use tramadol/acetaminophen?

Allergies to Ingredients. People who are allergic to any of the following should not take tramadol/acetaminophen.

  • Tramadol
  • Acetaminophen
  • Ultracet
  • Any other medicine known as an opioid
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific tramadol/acetaminophen products they stock.

Drug Interactions. Tramadol/acetaminophen should not be taken while you are using certain other medicines. Before taking  tramadol/acetaminophen, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have used recently. See the Interactions section for more details.

Children. Tramadol/acetaminophen should not be used in any child younger than 12 years of age or in a child younger than 18 years of age after a surgery to remove their tonsils or adenoids (tonsillectomy and/or adenoidectomy). Slow or shallow breathing that can lead to death may occur. 

Gut Blockage. Tramadol/acetaminophen should not be used if you have a blockage of your gut (bowel obstruction) or a narrowing of the stomach or intestines. Tramadol/acetaminophen can make these conditions worse. 

Slowed Gut Movement. Paralytic ileus is a type of ileus where your intestines are unable to move food through them. Tramadol/acetaminophen can make this condition worse.

Lung problems. Tramadol/acetaminophen should not be used if you have severe asthma, trouble breathing, or other lung problems. Tramadol/acetaminophen can make these conditions worse.

What should I know about tramadol/acetaminophen before using it?

Do not take tramadol/acetaminophen unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share tramadol/acetaminophen with other people, even if they have the same condition as you. It may harm them.

Keep tramadol/acetaminophen out of the reach of children. Tramadol/acetaminophen is a controlled substance because it can be misused or lead to dependence. Store tramadol/acetaminophen in a safe place to protect it from theft. It is illegal to sell or give away this medicine.

If you have been taking tramadol/acetaminophen on a regular basis, do not stop taking the medicine without talking to your healthcare provider. Stopping tramadol/acetaminophen too quickly can cause serious withdrawal effects. Call your healthcare provider right away if you have any of the following symptoms.

  • Feeling restless
  • Watery eyes or runny nose
  • Yawning
  • Sweating or chills
  • Muscle, joint, or back pain
  • Dilated pupils 
  • Irritability, anxiety, or trouble sleeping
  • Nausea, vomiting, diarrhea, or loss of appetite
  • Increase in blood pressure, breathing rate, or heart rate

Tramadol/acetaminophen can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how tramadol/acetaminophen affects you.

Do not take more than 4,000 mg of acetaminophen per day. Taking too much acetaminophen can cause serious liver problems that could lead to death. Talk to your pharmacist about which medicines contain acetaminophen. It can be found in Tylenol, some cough and cold medicines, some sleep medicines, and others. If you take too much acetaminophen, get emergency help right away, even if you do not feel sick.

People who are 65 years and older can be at greater risk for some side effects from tramadol/acetaminophen. Talk to your healthcare provider about your risks if you are in this age group.

Dispose of expired, unwanted, or unused tramadol/acetaminophen right away by taking your medicine to an authorized DEA-registered collector or drug take back program. If one is not available, you can mix medicine with dirt, coffee grounds, or cat litter, then place the mixture in a sealed plastic bag and throw the bag in the trash. 

Long-term use of tramadol/acetaminophen may affect your ability to become pregnant or get a partner pregnant. Talk with your healthcare provider if you have any concerns.

What should I tell my healthcare provider before using tramadol/acetaminophen?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if tramadol/acetaminophen is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Brain tumor or head injury
  • Seizures
  • Liver, kidney, or thyroid problems
  • Pancreas or gallbladder problems
  • Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
  • Obstructive sleep apnea
  • Problems peeing 
  • Diabetes
  • Abuse of street drugs or prescription medicines or living with someone who has this problem
  • Alcohol addiction
  • Opioid overdose
  • Mental health problems
  • Recent or upcoming surgery to remove your tonsils or adenoids   

Pregnancy. Tramadol/acetaminophen may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take tramadol/acetaminophen while you are pregnant or trying to get pregnant. If you take tramadol/acetaminophen on a regular basis during pregnancy, your baby may have withdrawal symptoms that can be life-threatening. Tell your healthcare provider if you took tramadol/acetaminophen during your pregnancy, especially near the end of your pregnancy.

Breastfeeding. Tramadol/acetaminophen passes into breast milk. Breastfeeding is not recommended while you are taking tramadol/acetaminophen. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take tramadol/acetaminophen while breastfeeding.

Interactions

Does tramadol/acetaminophen interact with foods or drinks?

There are no known interactions with tramadol/acetaminophen and food. 

Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using alcohol while taking tramadol/acetaminophen can cause you to overdose and die. 

Does tramadol/acetaminophen interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking  tramadol/acetaminophen.

  • A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
  • An opioid, such as oxycodone, morphine, codeine, or fentanyl, which is a medicine used for certain types of pain
  • A type of medicine called a mixed agonist/antagonist or partial agonist opioid analgesic, such as buprenorphine (Butrans, Sublocade), butorphanol, and others, which is used to treat certain types of pain
  • A selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), which is a medicine commonly used for anxiety and depression
  • A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • A type of medicine called a triptan, such as sumatriptan (Imitrex and others), eletriptan (Relpax), and others, which is commonly used to treat migraines
  • An antipsychotic, which is a medicine for certain mental health problems
  • A muscle relaxant, which is a medicine used for muscle spasm
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Warfarin (Coumadin, Jantoven), which is a blood thinner

Many other medicines may alter the blood levels of tramadol/acetaminophen. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with tramadol/acetaminophen. Always check with your healthcare provider.

Does Tramadol/Acetaminophen interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much tramadol/acetaminophen?

If you or someone else has used too much tramadol/acetaminophen, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of tramadol/acetaminophen?

If you miss a dose, skip the missed dose and only take the next dose at your usual time. Do not take double or extra doses.

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