Tramadol ER 100mg Tablets
WARNING: For all patients taking this drug:This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing.Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated.Children:This drug is not approved for use in children. Severe and sometimes deadly breathing problems have happened with tramadol in children. Sometimes, this happened after surgery to remove tonsils or adenoids and in children who were rapid metabolizers of tramadol. Do not give to a child younger than 12 years of age. Do not give to a child younger than 18 years of age who is very overweight, has certain health problems like sleep apnea or other lung or breathing problems, or has had surgery to remove tonsils or adenoids. If your child has been given this drug, ask the doctor about the benefits and risks. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid analgesic
Pharmacologic Class
Centrally acting analgesic; Opioid agonist; Serotonin-norepinephrine reuptake inhibitor (SNRI)
Pregnancy Category
Category C
FDA Approved
Mar 1995
DEA Schedule
Schedule IV
Overview
What is this medicine?
Tramadol ER is an extended-release pain medicine used to treat moderate to severe chronic pain around the clock. It works in your brain to change how your body feels and responds to pain. Because it's extended-release, you take it only once a day, and it releases the medicine slowly over time.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including trouble breathing and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Be sure to understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure safety.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including trouble breathing and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Be sure to understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure safety.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not crush, chew, or break the extended-release tablet. Swallow it whole.
- Take exactly as prescribed; do not take more or less than directed.
- Do not stop taking this medication suddenly without talking to your doctor, as withdrawal symptoms can occur.
- Avoid alcohol while taking tramadol, as it can increase the risk of serious side effects like respiratory depression.
- Avoid driving or operating heavy machinery until you know how tramadol affects you, as it can cause dizziness or drowsiness.
- Store safely away from children and pets, as accidental ingestion can be fatal.
Available Forms & Alternatives
Available Strengths:
- Tramadol 50mg Tablets
- Tramadol 50mg Tablets
- Tramadol Hcl ER 100mg (biphasic) Tb
- Tramadol ER 200mg Biphasic Tab
- Tramadol Hcl ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Capsules
- Tramadol ER 200mg Capsules
- Tramadol ER 300mg Capsules
- Tramadol 100mg Tablets
- Tramadol 50mg Tablets
- Tramadol 100mg Tablets
- Tramadol 5mg/ml Solution
- Tramadol Hcl 25mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg once daily (ER formulation)
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
chronic_pain:
Initial 100 mg once daily; titrate by 100 mg increments every 5 days to a maximum of 300 mg once daily. Some formulations may have different maximums (e.g., 400 mg/day for immediate release, but ER is typically lower).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Contraindicated for pain in children <12 years; contraindicated for post-tonsillectomy/adenoidectomy pain in children <18 years)
Adolescent:
Not established (Contraindicated for post-tonsillectomy/adenoidectomy pain in children <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for ER, but monitor closely.
Moderate:
Not recommended for patients with creatinine clearance <30 mL/min for ER formulations. For immediate release, extend dosing interval.
Severe:
Not recommended (CrCl <30 mL/min).
Dialysis:
Not recommended for ER formulations. For immediate release, supplemental dose not usually required after hemodialysis as only 7% is removed.
Hepatic Impairment:
Mild:
No specific adjustment for ER, but monitor closely.
Moderate:
Not recommended for patients with severe hepatic impairment (Child-Pugh Class C) for ER formulations. For immediate release, extend dosing interval.
Severe:
Not recommended (Child-Pugh Class C).
Confidence:
Medium
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. Its analgesic effect is due to a dual mechanism: binding of the parent drug and its active metabolite (M1, O-desmethyltramadol) to mu-opioid receptors, and weak inhibition of norepinephrine and serotonin reuptake, which enhances descending inhibitory pain pathways.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
Approximately 12 hours (for ER formulation)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of some ER formulations; however, some ER formulations recommend administration with food.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6-7 hours (parent drug); 7-9 hours (M1 metabolite)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 90%)
Unchanged:
Approximately 30% (parent drug); 60% (metabolites)
Pharmacodynamics
OnsetOfAction:
Not available (for ER, prolonged onset compared to IR)
PeakEffect:
Approximately 12 hours (for ER formulation)
DurationOfAction:
24 hours (for ER formulation)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; Cytochrome P450 3A4 Interaction; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or passing out
Feeling confused
Seizures
Chest pain or pressure, or a fast heartbeat
Trouble passing urine
Passing urine more often
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Change in eyesight
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially life-threatening condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea, upset stomach, or throwing up
Very bad headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur. This condition can cause severe health problems and may be fatal. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Most people do not experience serious side effects, and many side effects are mild and temporary. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, throwing up, or upset stomach
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Sweating a lot
Reporting Side Effects
If you have questions about side effects or want to report a side effect, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Report side effects online at https://www.fda.gov/medwatch
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or passing out
Feeling confused
Seizures
Chest pain or pressure, or a fast heartbeat
Trouble passing urine
Passing urine more often
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Change in eyesight
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially life-threatening condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea, upset stomach, or throwing up
Very bad headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur. This condition can cause severe health problems and may be fatal. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Most people do not experience serious side effects, and many side effects are mild and temporary. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, throwing up, or upset stomach
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Sweating a lot
Reporting Side Effects
If you have questions about side effects or want to report a side effect, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Report side effects online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or unusual thoughts
- Agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea (signs of serotonin syndrome)
- Seizures
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Stomach or bowel conditions, such as blockages or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or another medication containing the same active ingredient.
Use of specific medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Stomach or bowel conditions, such as blockages or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or another medication containing the same active ingredient.
Use of specific medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk factors with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Interactions with Alcohol
Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk factors with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Interactions with Alcohol
Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or loss of consciousness
- Pinpoint pupils
- Limp muscles
- Cold, clammy skin
- Slowed heart rate
- Seizures
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may be administered by emergency personnel.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity to tramadol or any component of the formulation
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, linezolid, St. John's Wort)
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir)
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Naloxone (may precipitate withdrawal)
Moderate Interactions
- Warfarin (increased INR/bleeding risk)
- Digoxin (potential for increased digoxin levels)
- Carbamazepine (decreased tramadol efficacy, increased seizure risk)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (level of consciousness, sedation)
Rationale: To assess baseline neurological function and identify risk for CNS depression.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To identify impairment that may require dose adjustment or contraindicate use.
Timing: Prior to initiation of therapy
History of substance abuse or mental health disorders
Rationale: To assess risk for addiction, abuse, and misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly during titration, monthly during maintenance)
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration, or if signs of respiratory depression occur.
Target: Normal for patient (e.g., 12-20 breaths/min)
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Sedation level
Frequency: Regularly, especially during initiation and dose titration.
Target: Alert and oriented, able to perform activities of daily living.
Action Threshold: Excessive somnolence, difficulty arousing, or confusion require dose reduction or discontinuation.
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: Constipation requiring intervention (e.g., laxatives, stool softeners).
Signs of abuse, misuse, or addiction
Frequency: At each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of diversion, dose escalation without clinical need, or other concerning behaviors require re-evaluation of therapy and potential referral.
Signs of serotonin syndrome
Frequency: Monitor closely, especially with concomitant serotonergic drugs
Target: Absence of symptoms (e.g., agitation, hallucinations, tachycardia, hyperthermia, rapid changes in blood pressure, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Action Threshold: Presence of symptoms requires immediate discontinuation of tramadol and supportive care.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/somnolence
- Dizziness
- Nausea
- Vomiting
- Constipation
- Seizures
- Signs of serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of opioid withdrawal (restlessness, lacrimation, rhinorrhea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Category C.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations with opioid exposure.
Second Trimester:
Risk of NOWS if used chronically.
Third Trimester:
High risk of NOWS if used chronically, and potential for respiratory depression in the neonate if used near delivery.
Lactation
Tramadol and its active metabolite (M1) are excreted into breast milk. Risk of serious adverse reactions in breastfed infants, including respiratory depression and sedation. Not recommended for breastfeeding mothers. If use is unavoidable, monitor infant closely for signs of sedation, respiratory depression, and poor feeding.
Infant Risk:
Moderate risk (L3)
Pediatric Use
Contraindicated for pain in children younger than 12 years of age. Contraindicated for post-tonsillectomy and/or adenoidectomy pain in children younger than 18 years of age. Not recommended for use in adolescents 12 to 18 years of age who are obese or have underlying sleep apnea or severe lung disease due to increased risk of respiratory depression.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., respiratory depression, constipation, dizziness, falls) and potential for decreased renal/hepatic function. Maximum daily dose for patients >75 years is often lower (e.g., 300 mg/day for IR, consult specific ER product labeling).
Clinical Information
Clinical Pearls
- Tramadol has a dual mechanism of action (opioid agonism and monoamine reuptake inhibition), which contributes to its analgesic effect but also increases the risk of serotonin syndrome when combined with other serotonergic drugs.
- The M1 metabolite (O-desmethyltramadol) is significantly more potent than the parent drug at mu-opioid receptors. Patients who are ultra-rapid metabolizers via CYP2D6 may experience increased opioid effects and toxicity.
- Extended-release formulations are designed for around-the-clock management of chronic pain and should not be used for acute pain or on an as-needed basis.
- Due to the risk of seizures, tramadol should be used with caution in patients with a history of epilepsy or other seizure disorders, or those taking medications that lower the seizure threshold.
- Always counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal of unused medication.
Alternative Therapies
- Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants for neuropathic pain)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (100mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.