Acetaminophen and tramadol

Name: Acetaminophen and tramadol

What are some other side effects of Acetaminophen and Tramadol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Dizziness.
  • Feeling sleepy.
  • Dry mouth.
  • Headache.
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Stomach pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Acetaminophen and Tramadol?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

ALERT U.S. Boxed Warning

Addiction, abuse, and misuse:

Tramadol/acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing tramadol/acetaminophen, and monitor all patients regularly for the development of these behaviors and conditions.

Life-threatening respiratory depression:

Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol. Monitor for respiratory depression, especially during initiation of tramadol/acetaminophen or following a dose increase.

Accidental ingestion:

Accidental ingestion of even one dose of tramadol/acetaminophen, especially by children, can result in a fatal overdose of tramadol.

Neonatal opioid withdrawal syndrome:

Prolonged use of tramadol/acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 interactions:

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol/acetaminophen requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.

Hepatotoxicity:

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4 g/day, and often involve more than one acetaminophen-containing product.

Risks from concomitant use with benzodiazepines or other CNS depressants:

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tramadol/acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Monitoring Parameters

Pain relief, respiratory rate, blood pressure, and pulse; signs of tolerance, abuse, or suicidal ideation; signs or symptoms of hypogonadism or hypoadrenalism (Brennan 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth, headache, nausea, or vomiting. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), passing out, severe dizziness, difficulty breathing, slow breathing, shallow breathing, noisy breathing, severe fatigue, severe constipation, severe abdominal pain, severe loss of strength and energy, angina, tachycardia, confusion, urinary retention, change in amount of urine passed, pale skin, vision changes, seizures, sexual dysfunction (males), amenorrhea, decreased libido, infertility, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Acetaminophen / tramadol Breastfeeding Warnings

Maternal tramadol use may result in serious adverse reactions in breastfed infants including excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. Newborns have limited capacity to metabolize the active 0-desmethyltramadol. Acetaminophen (paracetamol) is excreted in small amounts into breast milk and available published data have shown no ill effects when used in recommended doses. If this product is used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

Use is not recommended Excreted into human milk: Yes (acetaminophen); yes (tramadol) Comment: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.

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