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 for use in children younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids.
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 is acetaminophen and tramadol?
Tramadol is an opioid pain medicine (sometimes called, a narcotic). Acetaminophen is a less potent pain reliever that increases the effects of tramadol.
Acetaminophen and tramadol is a combination medicine used to treat moderate to severe pain.
Acetaminophen and tramadol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking acetaminophen and tramadol?
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 stomach or intestines; or
- if you have used an MAO inhibitor (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine) in the past 14 days.
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 this medicine. Your risk of a seizure may be higher if you have ever had:
- alcoholism or drug addiction;
- epilepsy or other seizure disorder;
- a metabolic disorder;
- a head injury or brain tumor; or
- if you have recently used sedatives, tranquilizers, or narcotic medications.
To make sure acetaminophen and tramadol is safe for you, tell your doctor if you have ever had:
- liver disease, or if you drink alcohol;
- kidney disease, urination problems;
- problems with your pancreas, gallbladder, or thyroid; or
- depression, mental illness, or a suicide attempt.
If you use this medicine while you are pregnant, your baby could become dependent on tramadol. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.
Do not breast-feed. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
How should I take acetaminophen and tramadol?
Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day. Do not take this medicine for longer than 5 days in a row.
This medicine may be habit forming, even at regular doses. Never share it with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away this medicine is against the law.
You may take this medicine with or without food, but take it the same way each time.
You should not stop using this medicine suddenly after long-term use. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep track of your medicine. Acetaminophen and tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or another person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
What should I avoid while taking acetaminophen and tramadol?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.
What are the possible side effects of acetaminophen and tramadol?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Like other narcotic medicines, tramadol can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should 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;
- a slow heart rate or weak pulse;
- a light-headed feeling, like you might pass out;
- seizure (convulsions);
- chest pain;
-
liver problems --upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
-
low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
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.
Common side effects may include:
- dizziness, drowsiness;
- stomach pain, nausea, loss of appetite;
- diarrhea, constipation; or
- sweating.
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.
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;
-
a sedative like Valium --diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others; or
-
drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.
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.
Where can I get more information?
Your pharmacist can provide more information about acetaminophen and tramadol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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