Ultracet contains a combination of tramadol and acetaminophen. Tramadol is a narcotic-like pain reliever. Acetaminophen is a less potent pain reliever that increases the effects of tramadol.
Ultracet is used to treat moderate to severe pain.
Ultracet may also be used for purposes not listed in this medication guide.
Important information
You should not use Ultracet if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
Do not take more Ultracet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin 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.
Ultracet may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
Before taking this medicine
You should not use Ultracet if you are allergic to acetaminophen (Tylenol, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
Seizures have occurred in some people taking Ultracet. Your risk of a seizure may be higher if you have any of these conditions:
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a history of drug or alcohol addiction;
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a history of epilepsy or other seizure disorder;
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a history of head injury;
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a metabolic disorder;
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an infection of your brain or spinal cord, such as meningitis or encephalitis;
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if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or
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if you have taken an MAO inhibitor (isocarboxazid, linezolid, methylene blue injections, phenelzine, rasagiline, selegiline, tranylcypromine) within the past 14 days.
To make sure Ultracet is safe for you, tell your doctor if you have:
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liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
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kidney disease;
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asthma or other breathing disorder;
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a stomach disorder; or
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a history of depression, mental illness, or suicide attempt.
Ultracet may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Ultracet is harmful to an unborn baby. Tramadol alone may have caused serious or fatal side effects in newborns of mothers who used the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Ultracet.
See also: Pregnancy and breastfeeding warnings (in more detail)
Acetaminophen and tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
How should I take Ultracet?
Take Ultracet exactly as prescribed by your doctor. 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.
Ultracet can be taken with or without food, but take it the same way each time.
The maximum amount of Ultracet is 2 tablets per dose, or 8 tablets per day. Ultracet should not be used for longer than 5 days in a row.
Do not stop using Ultracet suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Ultracet.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Ultracet is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
What happens if I miss a dose?
Since pain medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the 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 Ultracet overdose can be fatal.
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.
Overdose symptoms may also include shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, seizure, or coma.
What should I avoid?
Do not drink alcohol while you are taking Ultracet. Alcohol may cause a dangerous decrease in your breathing when used together with Ultracet. Alcohol may also increase your risk of liver damage while taking acetaminophen.
Ultracet may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Ultracet side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ultracet: 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. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop using Ultracet and call your doctor at once if you have:
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shallow breathing, slow heartbeat, weak pulse;
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a light-headed feeling, like you might pass out;
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confusion, agitation, hallucinations, unusual thoughts or behavior;
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fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;
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seizure (convulsions);
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easy bruising or bleeding;
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a red, blistering, peeling skin rash; or
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nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Ultracet side effects may include:
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dizziness, drowsiness, weakness, tired feeling;
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stomach pain, constipation, loss of appetite;
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dry mouth, blurred vision;
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feeling nervous or anxious;
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sweating, itching; or
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sleep problems (insomnia).
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.
See also: Side effects (in more detail)
What other drugs will affect Ultracet?
Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these medicines, or any narcotic pain medicine.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ultracet, especially:
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an antidepressant--citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, venlafaxine, vilazodone, and others; or
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an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine.
This list is not complete. Other drugs may interact with Ultracet, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
