Acetaminophen and tramadol

Name: Acetaminophen and tramadol

What is tramadol and acetaminophen, and how does it work (mechanism of action)?

Ultracet is a combination of two drugs, tramadol (Ultram) and acetaminophen (Tylenol) that is used to relieve moderate, acute pain such as pain following dental or surgical procedures. Tramadol and acetaminophen each relieve pain, but they do so by different mechanisms. Tramadol achieves pain relief in two ways. It binds to the -opioid receptor on nerves (the same mechanism that is responsible for the effectives of narcotics, such as morphine), and it also inhibits the reuptake by nerves of two neurotransmitters, serotonin and norepinephrine, that the nerves use to communicate with one another. This inhibition may lead to reduced transmission of pain signals from nerve to nerve in the spinal cord and brain. Acetaminophen achieves pain relief in the spinal cord and brain by increasing the threshold to pain, that is, by increasing the strength of the painful stimulus that is necessary in order to give rise to the sensation of pain. It does this by inhibiting an enzyme that makes prostaglandins. Ultracet was approved by the FDA in 2001.

Which drugs or supplements interact with tramadol and acetaminophen?

Carbamazepine (Tegretol) or rifampin can increase the rate of metabolic breakdown of tramadol, thus making tramadol less effective. Concomitant administration of quinidine, fluoxetine (Prozac), paroxetine (Paxil) and amitriptyline (Elavil, Endep), ketoconazole (Nizoral, Extina, Xolegel, Kuric), or erythromycin may reduce elimination of tramadol, increasing the risk for serious side effects from tramadol.

Combining tramadol with monoamine oxidase inhibitors (for example, Parnate), selective serotonin inhibitors (SSRIs, for example, fluoxetine [Prozac]), linezolid (Zyvox), St. John's wort, triptans (for example sumatriptan [Imitrex, Alsuma]) may result in severe side effects such as seizures or a condition called serotonin syndrome. Tramadol may increase central nervous system and respiratory depression when combined with alcohol, anesthetics, narcotics, tranquilizers, or sedative hypnotics.

What is the most important information I should know about acetaminophen and tramadol?

Do not take more than your recommended dose. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use this medicine if you have severe breathing problems, a blockage in your stomach or intestines, or if you have recently used an MAO inhibitor.

Acetaminophen and tramadol is not approved for use by anyone younger than 18 years old.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What other drugs will affect acetaminophen and tramadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What are some things I need to know or do while I take Acetaminophen and Tramadol?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how acetaminophen and tramadol 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.
  • Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
  • Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
  • This medicine 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 medicine.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking acetaminophen and tramadol with your other drugs.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • If you have been taking this medicine 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 acetaminophen and tramadol stops working well. Do not take more than ordered.
  • If you have been taking this medicine on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking acetaminophen and tramadol all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
  • Do not take this medicine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • Long-term use of an opioid drug like acetaminophen and tramadol may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
  • Taking an opioid drug like this medicine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
  • If you are 65 or older, use acetaminophen and tramadol with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

How is this medicine (Acetaminophen and Tramadol) best taken?

Use acetaminophen and tramadol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not take this medicine for longer than you were told by your doctor.
  • You will be watched closely to make sure you do not misuse, abuse, or become addicted to acetaminophen and tramadol.

What do I do if I miss a dose?

  • If you take this medicine 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 acetaminophen and tramadol is taken on an as needed basis. Do not take more often than told by the doctor.

Index Terms

  • Tramadol Hydrochloride and Acetaminophen

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Ultracet: Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg [contains corn starch]

Generic: Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg

Brand Names U.S.

  • Ultracet

For the Consumer

Applies to acetaminophen / tramadol: oral tablet

Along with its needed effects, acetaminophen / tramadol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / tramadol:

Rare
  • Burning, itching, and redness of the skin
  • chest pain
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • skin rash, hives, or itching skin
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / tramadol:

Symptoms of overdose
  • Abdominal or stomach pain
  • black, tarry stools
  • chest pain or discomfort
  • dark urine
  • difficulty with sleeping
  • disorientation
  • drowsiness to profound coma
  • fever
  • headache
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • light-colored stools
  • lightheadedness
  • loss of appetite
  • mood or other mental changes
  • nausea
  • pale or blue lips, fingernails, or skin
  • seeing, hearing, or feeling things that are not there
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some side effects of acetaminophen / tramadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • anxiety
  • belching
  • bloated or full feeling
  • constipation
  • dry mouth
  • excess air or gas in the stomach or intestines
  • false or unusual sense of well-being
  • feeling of warmth
  • heartburn
  • increase in bowel movements
  • increased sweating
  • indigestion
  • loose stools
  • loss of strength or energy
  • muscle pain or weakness
  • numbness or tingling of the hands, legs, and feet
  • painful or difficult urination
  • redness of the face, neck, arms, and occasionally the upper chest
  • sleepiness or unusual drowsiness
  • soft stools
  • stomach discomfort
  • weight loss
Rare
  • Abnormal thinking
  • blurred vision
  • change in vision
  • clumsiness, unsteadiness, trembling, or problems with muscle control or coordination
  • cold sweats
  • continuing ringing, buzzing, or unexplained noise in the ears
  • crying
  • decrease in the frequency or amount of urination
  • decreased awareness or responsiveness
  • decreased interest in sexual intercourse
  • depression
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dysphoria
  • euphoria
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of constant movement of self or surroundings
  • feeling unusually cold
  • headache, severe or continuing
  • increased muscle tone
  • involuntary muscle contractions
  • loss of memory
  • loss of sense of reality
  • loss of sexual ability, desire, drive, or performance
  • migraine headache
  • morbid dreaming
  • paranoia
  • pounding in the ears
  • problems with memory
  • quick to react or overreact emotionally
  • rapidly changing moods
  • sensation of spinning
  • severe stomach pain
  • shakiness and unsteady walk
  • shivering
  • swelling of the tongue
  • vomiting of blood or material that looks like coffee grounds

Dialysis

Patients may receive their regular dose of acetaminophen-tramadol on the day of dialysis since less than 7% of tramadol is removed by hemodialysis.

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