Ultracet Side Effects

Generic name: acetaminophen / tramadol

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Note: This document provides detailed information about Ultracet Side Effects associated with acetaminophen / tramadol. Some dosage forms listed on this page may not apply specifically to the brand name Ultracet.

Applies to acetaminophen / tramadol: oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment, to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the past 14 days.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
• Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine

• Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, unusual tiredness or weakness, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain acetaminophen or tramadol, check with your doctor. Taking them together with this medicine may cause an overdose.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you or your child are taking this medicine. Serious side effects can occur if your doctor or dentist gives you certain medicines without knowing that you have been taking this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Ultracet® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also, tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has tried to commit suicide.

This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

Do not change the dose or suddenly Stop taking acetaminophen / tramadol without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.

Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melted bits of ice in your mouth, or a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Ultracet

Some side effects of acetaminophen / tramadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Ultracet

Along with its needed effects, acetaminophen / tramadol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / tramadol:

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / tramadol:

Symptoms of overdose

• black, tarry stools
• dark urine
• depression
• disorientation
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness to profound coma
• fever
• headache
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of appetite
• mood or other mental changes
• nausea
• pale or blue lips, fingernails, or skin
• seeing, hearing, or feeling things that are not there
• stomach pain
• trouble sleeping
• unpleasant breath odor
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting of blood
• yellow eyes or skin

For healthcare professionals

Applies to acetaminophen / tramadol: oral tablet.

General adverse events

The most common adverse reactions include nausea, somnolence, and dizziness.^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased transaminases, abnormal hepatic function

Acetaminophen:

• Frequency not reported: Acute liver failure

Tramadol:

• Frequency not reported: Hepatitis, liver failure^[Ref]

Acetaminophen-Tramadol

Psychiatric

• Very common (10% or more): Insomnia
• Common (1% to 10%): Altered mood (anxiety, nervousness, euphoric mood), sleep disorders
• Uncommon (0.1% to 1%): Depression, hallucinations, nightmares, amnesia
• Rare (less than 0.1%): Delirium, dependency
• Frequency not reported: Depersonalization, paranoia
• Postmarketing reports: Abuse

Tramadol:

• Frequency not reported: Psychic reactions including mood changes, withdrawal symptoms^[Ref]

A psychic reaction with symptoms of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations has been reported with tramadol use. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paresthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).^[Ref]

Acetaminophen-Tramadol

Gastrointestinal

• Very common (10% or more): Nausea (up to 18%), constipation (up to 11%)
• Common (1% to 10%): Vomiting, dyspepsia, dry mouth, diarrhea, abdominal pain, flatulence
• Uncommon (0.1% to 1%): Dysphagia, melena, tongue edema
• Frequency not reported: Gastrointestinal bleeding^[Ref]

Acetaminophen-Tramadol

Tramadol

Nervous system

• Very common (10% or more): Dizziness (up to 15%), Somnolence (up to 12%), headache (up to 11%),
• Common (1% to 10%): Tremor, confusion, paresthesia, hypoesthesia
• Uncommon (0.1% to 1%): Migraine, hypertonia, stupor, involuntary muscle contractions
• Rare (less than 0.1%): Seizures, ataxia, speech disorders

Tramadol:

• Frequency not reported: Serotonin syndrome^[Ref]

Acetaminophen-Tramadol

Dermatologic

• Common (1% to 10%): Sweating, pruritus, rash
• Uncommon (0.11% to 1%): dermal reactions such as rash and urticaria^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Albuminuria, micturition disorders (dysuria and urinary retention)
• Frequency not reported: Impotence^[Ref]

Cardiovascular

Acetaminophen-Tramadol:

• Uncommon: Hypertension, palpitations, tachycardia, arrhythmia

Less than 1%: Aggravated hypertension, hypotension, chest pain

Tramadol:

• Frequency not reported: Postural hypotension, bradycardia, syncope, vasodilation, myocardial ischemia
• Postmarketing reports: QT prolongation/torsade de pointes^[Ref]

Postmarketing reports of QT prolongation and/or torsade de pointes have been received for tramadol-containing products. In many cases, patients were taking another drug associated with QT prolongation, had risk factors for QT prolongation such as hypokalemia, or in the overdose setting.^[Ref]

Hypersensitivity

Acetaminophen:

• Frequency not reported: Allergic reactions (primarily skin rash)

Tramadol:

• Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, urticarial and Stevens-Johnson syndrome/TENS^[Ref]

Respiratory

Acetaminophen-Tramadol:

• Uncommon (0.1% to 1%): Dyspnea

Tramadol:

• Frequency not reported: Asthma aggravated^[Ref]

Other

• Common (1% to 10%): Asthenia, fatigue, hot flushes
• Uncommon (0.1% to 1%): Tinnitus, shivers^[Ref]

Hematologic

• Frequency not reported: Anemia

Acetaminophen:

• Frequency not reported: Blood dyscrasias including thrombocytopenia and agranulocytosis^[Ref]

Acetaminophen-Tramadol

Ocular

• Uncommon (0.1% to 1%): Abnormal vision
• Rare (less than 0.1%): Blurred vision, mydriasis, miosis^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Frequency not reported: Hypoglycemia, decreased weight
• Postmarketing reports: Hyponatremia^[Ref]

Severe hyponatremia and/or SIADH have been reported, most often in females over 65 years old, and within the first week of therapy.^[Ref]

Endocrine

• Common (1% to 10%): Prostatic disorder

Opioids:

• Postmarketing reports: Adrenal insufficiency; androgen deficiency^[Ref]

See also:

Further information

Ultracet side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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