Acetaminophen-Tramadol, Oral Tablet

1. Tramadol/acetaminophen oral tablet is available as a brand-name drug and a generic drug. Brand name: Ultracet.
2. Tramadol/acetaminophen comes only as a tablet you take by mouth.
3. Tramadol/acetaminophen is used to treat pain. It’s typically used for no longer than 5 days.

Tramadol/acetaminophen is a controlled substance, which means its use is regulated by the government.

Tramadol/acetaminophen is a prescription drug. It comes only as an oral tablet.

This drug is available as the brand-name drug Ultracet. It’s also available in a generic form.

Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

This drug is a combination of two or more drugs in a single form. It’s important to know about all the drugs in the combination because each drug may affect you in a different way.

Why it’s used

Tramadol/acetaminophen is used to treat moderate to severe pain for up to 5 days. It may work better for pain than using either tramadol or acetaminophen alone.

This drug may be used instead of full-dose acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioid combinations used for pain.

How it works

This medication contains tramadol and acetaminophen. Tramadol belongs to a class of pain drugs called opioids (narcotics). Acetaminophen is an analgesic (pain reliever), but it’s not in the opioid or aspirin classes of drugs.

Tramadol treats pain by working on the central nervous system. It may also lessen pain by working on norepinephrine and serotonin in your brain.

Acetaminophen treats pain and decreases fever.

Acetaminophen/tramadol oral tablet may cause drowsiness. Don’t drive or use heavy machinery until you know how your body reacts to this drug.

Acetaminophen/tramadol can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking acetaminophen/tramadol. This list does not include all possible side effects.

For more information on the possible side effects of Acetaminophen/tramadol, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

Common side effects

The more common side effects that can occur with this medication when you take it for 5 days include:

• feeling drowsy, sleepy, or tired
• decreased concentration and coordination
• constipation
• dizziness

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Allergic reaction, which can be life threatening. Symptoms can include:
  • rash
  • itching
• Liver damage and liver failure. Symptoms of liver damage can include:
  • dark urine
  • pale stools
  • nausea
  • vomiting
  • loss of appetite
  • stomach pain
  • yellowing of your skin or the whites of your eyes
• Seizure
• Increased risk of suicide
• Serotonin syndrome, which can be fatal if left untreated. Symptoms can include:
  • agitation
  • hallucinations
  • coma
  • increased heart rate or rapid heartbeat
  • changes in blood pressure
  • fever
  • increased reflexes
  • lack of coordination
  • nausea
  • vomiting
  • diarrhea
  • seizures
• Slowed breathing
• Increased symptoms of depression
• Withdrawal (affects people who have taken this drug for a long time or formed a habit of taking the drug). Symptoms can include:
  • restlessness
  • trouble sleeping
  • nausea and vomiting
  • diarrhea
  • loss of appetite
  • increased blood pressure, heart rate, or breathing rate
  • sweating
  • chills
  • muscle aches
  • wide pupils (mydriasis)
  • irritability
  • back or joint pain
  • weakness
  • stomach cramps
• Adrenal insufficiency. Symptoms can include:
  • long-lasting tiredness
  • muscle weakness
  • pain in your abdomen
• Androgen deficiency. Symptoms can include:
  • tiredness
  • trouble sleeping
  • decreased energy

Acetaminophen/tramadol can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with acetaminophen/tramadol. This list does not contain all drugs that may interact with acetaminophen/tramadol.

Before taking acetaminophen/tramadol, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take.

Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Examples of drugs that can cause interactions with tramadol/acetaminophen are listed below.

Drugs that cause drowsiness

Tramadol/acetaminophen may worsen the effects these medications have on your central nervous system or breathing. Examples of these drugs include:

• medications used for sleep
• narcotics or opioids
• pain drugs that act on the central nervous system
• mind-altering (psychotropic) medications

Acetaminophen

Using this medication with other drugs that contain acetaminophen can increase the risk of liver damage.

Don’t take tramadol/acetaminophen with medications that list acetaminophen, or the abbreviation APAP, as an ingredient.

Drugs that can cause seizures

Combining this medication with the following drugs increases your risk for seizures:

• antidepressants such as:
  • selective serotonin reuptake inhibitors (SSRIs)
  • tricyclics
  • monoamine oxidase (MAO) inhibitors
• neuroleptics
• other opioids (narcotics)
• weight loss medications (anorectics)
• promethazine
• cyclobenzaprine
• medications that decrease the seizure threshold
• naloxone, which may be used to treat overdose of tramadol/acetaminophen

Drugs that affect brain serotonin

Using this medication with drugs that work on serotonin in the brain may increase the risk of serotonin syndrome, which can be fatal. Symptoms can include agitation, sweating, muscle twitches, and confusion.

Examples of these drugs include:

• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and sertraline
• serotonin and norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine
• tricyclic antidepressants (TCAs) such as amitriptyline and clomipramine
• monoamine oxidase inhibitors (MAOIs) such as selegiline and phenelzine
• migraine medications (triptans)
• linezolid, an antibiotic
• lithium
• St. John’s wort, an herb

Drugs that affect liver function

Drugs that change how the liver breaks down tramadol can increase the risk of serotonin syndrome. Examples of medications that shouldn’t be used with tramadol/acetaminophen include:

• quinidine, used to regulate heart rate
• depression or anxiety drugs such as fluoxetine, paroxetine, or amitriptyline
• anti-infective drugs such as ketoconazole or erythromycin

Anesthetics

Using this medication with anesthetic medications and other opioids can slow your breathing.

Seizure medication

Carbamazepine changes how your liver breaks down tramadol, which may decrease how well tramadol/acetaminophen treats your pain.

Carbamazepine can be used to treat seizures. Using it with tramadol may hide that you’re having a seizure.

Heart medication

Using digoxin with tramadol may increase the levels of digoxin in your body.

Blood thinner (anticoagulant)

Taking warfarin with tramadol/acetaminophen can cause you to bleed more if you have a wound.

The acetaminophen/tramadol dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using acetaminophen/tramadol to treat
• your age
• the form of acetaminophen/tramadol you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

All possible dosages and forms may not be included here.

Dosage for short-term treatment of acute pain

Generic: Tramadol/acetaminophen

• Form: oral tablet
• Strengths: 37.5 mg tramadol/325 mg acetaminophen

Brand: Ultracet

• Form: oral tablet
• Strengths: 37.5 mg tramadol/325 mg acetaminophen

Adult dosage (ages 18 years and older)

• Typical dosage: 2 tablets taken every 4–6 hours as needed.
• Maximum dosage: 8 tablets per 24 hours.
• Treatment duration: This medication should not be taken for longer than 5 days.

Child dosage (ages 0–17 years)

It has not been established that this drug is safe or effective in children younger than 18 years.

Special dosage considerations

For people with reduced kidney function: If you have reduced kidney function, the time between your doses may be changed to every 12 hours.

For people taking central nervous system depressants or alcohol: Your dosage may need to be decreased if you’re using alcohol or any of the following drugs:

• opioids
• anesthetic agents
• narcotics
• phenothiazines
• tranquilizers
• sedative hypnotics

Acetaminophen/tramadol oral tablet is used for short-term treatment of up to 5 days. If you use tramadol for a long time, you may become tolerant to its effects.

It may also be habit-forming, which means it can cause mental or physical dependence. This can cause you to have withdrawal symptoms when you stop using it.

This drug comes with serious risks if you don’t take it as prescribed by your doctor.

If you take too much: You shouldn’t take more than eight tablets in a 24-hour period. This maximum amount may be less if you have certain health conditions. Taking too much of this medication can increase your risk for decreased breathing, seizures, liver damage, and death.

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

If you stop taking it suddenly: This medication can be habit-forming if you take it for a long time. You could develop a physical dependence. If you stop suddenly after taking it for a long time, you may experience withdrawal symptoms. Symptoms of withdrawal can include:

• restlessness
• trouble sleeping
• nausea and vomiting
• diarrhea
• loss of appetite
• increased blood pressure, heart rate, or breathing rate
• sweating
• chills
• muscle aches

Slowly decreasing doses and increasing the time between doses may lower your risk for withdrawal symptoms.

How to tell if the drug is working: Your pain should decrease.

This drug comes with various warnings.

Seizure warning

You can have seizures when you take doses of tramadol that are normal or higher than normal. Tramadol is one of the drugs in this combination medication. Your risk for seizures increases if you:

• take doses that are higher than recommended
• have a history of seizures
• take tramadol with other medications, such as antidepressants, other opioids, or other drugs that affect brain function

Suicide risk warning

The combination of tramadol and acetaminophen may increase the risk of suicide. Your risk may be higher if you have depression, are thinking about suicide, or have misused medications in the past.

Serotonin syndrome warning

The combination of tramadol and acetaminophen may increase the risk of serotonin syndrome. This risk is possible if you have certain medical problems or are taking certain medications. Symptoms of serotonin syndrome may include:

• agitation
• increased heart rate or rapid heartbeat
• changes in blood pressure
• muscle weakness
• fever
• seizure

Allergy warning

Don’t take this medication if you’ve ever had an allergic reaction before to tramadol, acetaminophen, or the opioid class of medications. Taking it a second time after an allergic reaction could cause death.

This medication can cause a severe allergic reaction. Stop taking the medication right away and call your doctor if you have any of these symptoms after taking it:

• trouble breathing
• swelling of your throat or tongue
• itching and hives
• blistering, peeling, or red skin rash
• vomiting

Though rare, some people have had serious allergic reactions that lead to death after their first tramadol dose.

Food interaction warning

Taking this medication with food may make it take longer to relieve your pain.

Alcohol interaction warning

Using alcohol while taking this drug can cause a sedative effect that can be dangerous. It can cause slowed reflexes, poor judgment, and sleepiness.

When used with alcohol, this medication can also decrease breathing and cause liver damage. If you misuse alcohol while taking this drug, you have an increased risk for suicide.

Warnings for people with certain health conditions

For people with kidney disorder. Your kidneys may remove tramadol from your body more slowly. This increases your risk for dangerous side effects. You may need to take this medication less often each day.

For people with liver disease. This medication can increase your risk for liver failure. You shouldn’t use this medication if you have liver disease.

For people with seizures. This medication can increase your risk for seizure if you have seizures (epilepsy) or a history of seizures. This can happen if you take normal or higher doses. It can also increase your risk for getting a seizure if you:

• have head trauma
• have a problem with your metabolism
• are undergoing alcohol or drug withdrawal
• have an infection in your brain (central nervous system)

For people with depression. This medication can worsen your depression if you take it with medications that help with antidepressants, sleep (sedative hypnotics), tranquilizers, or muscle relaxers. This drug can also increase your risk for suicide if:

• your mood is unstable
• you’re considering or have attempted suicide
• you have misused tranquilizers, alcohol, or other medications that act on the brain

If you’re depressed or thinking about suicide, tell your doctor. They may suggest a pain medication from a different drug class.

For people with decreased breathing. This medication can decrease your breathing more if you have decreased breathing or are at risk for decreased breathing. It may be better for you to take a pain medication from a different drug class.

For people with brain pressure or head injury. If you have a head injury or increased pressure on your brain, this medication may:

• worsen your breathing
• increase pressure in your cerebrospinal fluid
• cause the pupils of your eyes to be small
• cause behavioral changes

These effects may hide or make it hard for your doctor to check on your head injury. They may also make it difficult to tell if your medical problems are getting worse or better.

For people with a history of addiction. This medication can increase the risk of overdose or death if you have an addiction disorder, or misuse opioids, narcotics, or other drugs.

For people with stomach pain: If you have a condition that causes pain in your abdomen, such as severe constipation or obstruction, this medication may lessen that pain. That could make it more difficult for your doctor to diagnose your condition.

Warnings for other groups

For pregnant women. Tramadol, one of the drugs in this medication, is passed to a fetus during pregnancy. Long-term use of this medication during pregnancy may cause physical dependence and withdrawal symptoms in the baby at birth. Signs of withdrawal in a baby may include:

• blotchy skin
• diarrhea
• excessive crying
• irritability
• fever
• poor feeding
• seizures
• sleep problems
• tremors
• vomiting

Talk to your doctor if you’re pregnant or plan to become pregnant. This drug should only be used during pregnancy if the potential benefit justifies the potential risk. It shouldn’t be used before or during labor.

For women who are breastfeeding. Both tramadol and acetaminophen pass through breast milk. This drug combination hasn’t been studied in babies. The medication shouldn’t be used before or after delivery to treat pain if you plan to breastfeed.

For seniors. Use with caution if you’re older than 65 years. Your dosage may need to be changed if you have liver, kidney, or heart problems, other diseases, or take medications that may interact with this medication.

For children: Keep this medication out of reach of children. A child who accidentally takes this medication or overdoses may experience decreased breathing, liver damage, and even death.

Call your local poison control center if your child has accidentally taken this medication, even if they feel well. The center will help you decide if you need to go to the emergency room.

Keep these considerations in mind if your doctor prescribes tramadol/acetaminophen for you.

General

• You can cut or crush the tablet.

Storage

• Store at a temperature between 59°F and 86°F (15°C and 30°C).
• Do not freeze this medication.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

To help keep you safe during your treatment with this drug, your doctor may check for:

• improvement in pain
• pain tolerance
• problems breathing
• seizures
• depression
• skin changes
• changes in your pupils
• stomach or intestinal problems (such as constipation or diarrhea)
• symptoms of withdrawal when this medication is being stopped
• changes in kidney function

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be more suitable for you than others. Options may include full-dose acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and other opioid combinations.

If you have a higher risk for decreased breathing, are depressed or suicidal, or have a history of addiction, it may be better to take a pain medication from a different class of drugs.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.