Acetaminophen and tramadol is a combination medicine used for the short term (5 days or less) treatment of severe acute pain.

Acetaminophen and tramadol contains an opioid-like medicine, and may be habit-forming.

Acetaminophen and tramadol is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Acetaminophen and tramadol may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or tramadol (Ultram), or if you have:

• severe asthma or breathing problems, a blockage in your digestive tract (stomach or intestines); or
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Acetaminophen and tramadol is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have ever had:

• a metabolic disorder;
• breathing problems, sleep apnea, a head injury, brain tumor, seizures; or
• alcoholism or drug addiction, or if you have recently used sedatives, tranquilizers, or narcotic medications.

Tell your doctor if you have ever had:

• liver disease, or if you drink alcohol;
• kidney disease (or if you are on dialysis), urination problems;
• problems with your pancreas, gallbladder, or thyroid; or
• depression, mental illness, or a suicide attempt.

Using this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Acetaminophen And Tramadol (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

This medicine can slow or stop your breathing, and death may occur. A person caring for you should administer naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, sleep apnea (breathing stops during sleep), a light-headed feeling, like you might pass out, seizures;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop), chest pain;
• liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness;
• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, diarrhea;
• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• dizziness, drowsiness, sweating; or
• stomach pain, nausea, loss of appetite, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid driving or hazardous activity until you know how this medicine will affect you.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP).