This combination product contains two medications: tramadol and acetaminophen. Tramadol belongs to a group of medications called opioid analgesics and acetaminophen belongs to a group of medications called analgesics. This combination medication is used to manage moderate to moderately severe pain in adults. It decreases pain by working on the central nervous system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual recommended dose of tramadol - acetaminophen is 1 or 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Tramadol – acetaminophen can be taken with or without food. Swallow the tablets whole. Cutting, breaking, chewing, crushing, or dissolving the tablets can result in dangerous side effects, including death. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Each peach, film-coated, capsule-shaped tablet, engraved with "T37.5" on one side and "A325" on the other, contains 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. Nonmedicinal ingredients: hydroxypropyl cellulose, Kollicoat IR, magnesium stearate, microcrystalline cellulose (Avicel PH-101 and Avicel PH-102), sodium starch glycolate, pregelatinized corn starch, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow, iron oxide red, and iron oxide black.

Do not take this medication if you:

• are allergic to tramadol, acetaminophen, or any ingredients of the medication
• are allergic to other opioid medications (e.g., codeine, morphine)
• are experiencing acute alcoholism or delirium tremens
• are experiencing acute asthma or other obstructive airway disease
• are experiencing acute respiratory depression
• have mild pain, which can be treated with other pain medications
• have or may have an abdominal condition that may require surgery (appendicitis, pancreatitis)
• are intoxicated with alcohol or other medications such as hypnotics, other opioids such as codeine or morphine, or psychotropic medications (i.e., medications for mental health conditions)
• are pregnant, in labour, delivering a baby, or breast-feeding
• are taking or have taken MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide) within the last 14 days
• have a blockage of the gastrointestinal tract, particularly paralytic ileus
• have a convulsive (seizure) disorder
• have a head injury, a brain tumour, or increased pressure inside the head or spinal cord
• have severe central nervous system (CNS) depression (e.g., slowed nervous system)
• have severely decreased kidney function
• have severely decreased liver function
• are under 18 years old and have had surgery to treat obstructive sleep apnea

Do not give this medication to children less than 12 years old.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• decreased appetite
• decreased interest in sexual activity
• decreased sexual ability
• dizziness
• drowsiness
• dry mouth
• fainting
• headache
• itching
• nausea
• sweating
• trouble sleeping
• vision problems
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fast, slow, or irregular heartbeat
• hallucinations (e.g., seeing or hearing things that aren't there)
• low blood pressure (e.g., dizziness, fainting, light-headedness)
• poor muscle coordination
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
• symptoms of low sodium in the blood (e.g., tiredness, weakness, confusion, achy, stiff or uncoordinated muscles)
• withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of taking too much medication, e.g.,:
• cold, clammy skin
• confusion
• hallucinations (hearing or seeing things that aren't there)
• shallow, rapid breathing
• severe drowsiness
• decreased coordination
• floppy muscles
• seizures
• unconsciousness
• signs of a severe allergic reaction, e.g.:
• difficulty breathing
• hives
• swelling of the lips, mouth, throat, or tongue
• signs of a severe skin reaction, e.g.:
• high fever
• painful blisters on the skin, mouth, or eyes
• rash
• skin peeling off
• sores
• slow or weak breathing
• symptoms of a bowel blockage (e.g., abdominal pain, severe constipation, nausea)
• symptoms of serotonin toxicity (e.g., confusion, fast heartbeat, hallucinations, high blood pressure, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal conditions: Tramadol - acetaminophen may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Accidental use: When tramadol-acetaminophen is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Keep this medication out of sight and reach of children.

Acetaminophen overuse: Although acetaminophen is usually considered a safe medication, overuse of acetaminophen can cause liver damage, including liver failure causing death or requiring a liver transplant. It is important that you do not take more of tramadol - acetaminophen than prescribed by your doctor. Acetaminophen can be found in many medications that are available without a prescription. Read the labels carefully to make sure you are not taking more than the recommended adult dose of acetaminophen when you consider the different medications that you are taking. If you have questions about the amount of acetaminophen you are taking, contact your pharmacist or doctor.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including how your body responds to injury or stress. On rare occasions, tramadol may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Alcohol and other medications that cause drowsiness: People taking this medication should avoid consuming alcohol or medications that cause drowsiness, such as sedatives or certain antidepressants. Doing so can increase the risk of dangerous and potentially life threatening side effects including breathing problems, seizures, and drowsiness. 

Breathing: Tramadol - acetaminophen can suppress breathing. If you have asthma, chronic obstructive pulmonary disease, or are otherwise at risk for breathing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Tramadol can cause physical dependence, psychological dependence, and addiction. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor. Do not stop taking this medication without talking to your doctor or pharmacist.

Drowsiness/reduced alertness: This medication may cause drowsiness or affect the mental abilities needed to perform hazardous tasks. Combining this medication with alcohol or other medications that cause drowsiness (e.g., antidepressants, sleeping pills, anxiety medications) should be avoided, since additional drowsiness and dizziness can occur and be dangerous and possibly fatal. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. If you have had a recent head injury, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: Tramadol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. Although this is generally a concern only when you are taking high doses of tramadol or you take too much at one time, if you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The kidneys are partially responsible for removing tramadol from the body. Kidney disease or decreased kidney function may cause this medication to build up in the body, causing side effects. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severely decreased kidney function.

Liver function: The liver is partially responsible for removing tramadol and acetaminophen from the body. Liver disease or decreased liver function may cause this medication to build up in the body, causing side effects. If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be used by people who are experiencing severe liver failure.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking tramadol - acetaminophen. This is more likely to occur for those who take water pills, have a salt-restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. Get up slowly when rising from a sitting or lying down position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Seizures: Tramadol may cause seizures, especially when higher doses are used or when taken with other medications such as:

• cyclobenzaprine
• monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
• neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
• other opioids (e.g., morphine, codeine, oxycodone)
• promethazine
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine)
• tricyclic antidepressants (TCAs; e.g., amitriptyline)

The risk of seizures is also higher for people with a history of seizures, or who are at risk of seizures (e.g., people with head trauma). If you have a history of seizures, or are at risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin toxicity: Severe reactions are possible when tramadol is combined with medications used to treat depression. The combination of tramadol and MAO inhibitors must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

Sleep apnea: Sleep apnea is a condition where you stop breathing for short periods while asleep. This can be caused or made worse by medications such as tramadol-acetaminophen. If you have sleep apnea or anyone notices you stop breathing from time to time while sleeping, contact your doctor as soon as possible.

Surgery: Tramadol may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: Taking this medication during pregnancy may affect the developing baby, causing dangerous withdrawal symptoms when the baby is born. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and are taking tramadol - acetaminophen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used by people under 18 years of age.

Seniors: Seniors may be more likely to experience side effects from this medication. Lower doses may be required.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.