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Acetaminophen / tramadol Side Effects

Not all side effects for acetaminophen / tramadol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to acetaminophen / tramadol: oral tablet

In addition to its needed effects, some unwanted effects may be caused by acetaminophen / tramadol. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / tramadol:

Rare
  • Burning, itching, and redness of the skin
  • chest pain
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shortness of breath
  • skin rash, hives, or itching skin
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips

If any of the following symptoms of overdose occur while taking acetaminophen / tramadol, get emergency help immediately:

Symptoms of overdose
  • Abdominal or stomach pain
  • black, tarry stools
  • chest pain or discomfort
  • dark urine
  • difficulty with sleeping
  • disorientation
  • drowsiness to profound coma
  • fever
  • headache
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • light-colored stools
  • 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
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with acetaminophen / tramadol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • anxiety
  • belching
  • bloated or full feeling
  • constipation
  • dry mouth
  • excess air or gas in the stomach or intestines
  • false or unusual sense of well-being
  • feeling of warmth
  • heartburn
  • increase in bowel movements
  • increased sweating
  • indigestion
  • loose stools
  • loss of strength or energy
  • muscle pain or weakness
  • numbness or tingling of the hands, legs, and feet
  • painful or difficult urination
  • redness of the face, neck, arms, and occasionally the upper chest
  • sleepiness or unusual drowsiness
  • soft stools
  • stomach discomfort
  • weight loss
Rare
  • Abnormal thinking
  • blurred vision
  • change in vision
  • clumsiness, unsteadiness, trembling, or problems with muscle control or coordination
  • cold sweats
  • continuing ringing, buzzing, or unexplained noise in the ears
  • crying
  • decrease in the frequency or amount of urination
  • decreased awareness or responsiveness
  • decreased interest in sexual intercourse
  • depression
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dysphoria
  • euphoria
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of constant movement of self or surroundings
  • feeling unusually cold
  • headache, severe or continuing
  • increased muscle tone
  • involuntary muscle contractions
  • loss of memory
  • loss of sense of reality
  • loss of sexual ability, desire, drive, or performance
  • migraine headache
  • morbid dreaming
  • paranoia
  • pounding in the ears
  • problems with memory
  • quick to react or overreact emotionally
  • rapidly changing moods
  • sensation of spinning
  • severe stomach pain
  • shakiness and unsteady walk
  • shivering
  • swelling of the tongue
  • vomiting of blood or material that looks like coffee grounds

For Healthcare Professionals

Applies to acetaminophen / tramadol: oral tablet

General

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

Hepatic

Acetaminophen-Tramadol
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]

Psychiatric

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
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]

Gastrointestinal

Acetaminophen-Tramadol
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

Tramadol
Frequency not reported: Gastrointestinal bleeding[Ref]

Nervous system

Acetaminophen-Tramadol
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]

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[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

Acetaminophen-Tramadol
Frequency not reported: Anemia

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

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[Ref]

Endocrine

Common (1% to 10%): Prostatic disorder[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Ultracet (acetaminophen-tramadol)" Johnson and Johnson Medical Inc, Arlington, TX.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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