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Tramadol is a narcotic-like pain reliever.
Tramadol is used to treat moderate to severe pain in adults.
The extended-release form of tramadol is for around-the-clock treatment of pain. The extended-release form of tramadol is not for use on an as-needed basis for pain.
Seizures have been reported in patients taking tramadol. Your risk of seizures is higher if you are taking higher doses of tramadol over what is recommended. Seizure risk is also higher in those with a seizure disorder or those taking certain antidepressants or opioid medications.
Tramadol should not be used if you are suicidal or prone to addiction.
You should not take tramadol if you have severe breathing problems, a blockage in your stomach or intestines, or if you have recently used alcohol, sedatives, tranquilizers, narcotic medication, or an MAO inhibitor (isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others).
Tramadol can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Tramadol should not be given to a child younger than 12 years old. Ultram ER should not be given to anyone younger than 18 years old.
Taking tramadol during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
You should not take tramadol if you are allergic to it, or if you have:
severe asthma or breathing problems;
a blockage in your stomach or intestines;
if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications; or
if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).
Tramadol should not be given to a child younger than 12 years old. Ultram ER should not be given to anyone younger than 18 years old.
Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.
Avoid giving this medicine to children between 12 to 18 years of age who have conditions that may cause breathing problems.
Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have ever had:
a head injury, epilepsy or other seizure disorder;
f you also use certain antidepressants, muscle relaxants, opioids, or other medications.
If you use tramadol while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breast-feed while taking tramadol. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
To make sure tramadol is safe for you, tell your doctor if you have ever had:
breathing problems, sleep apnea;
liver or kidney disease;
urination problems;
problems with your gallbladder, pancreas, or thyroid;
a stomach disorder; or
mental illness, or suicide attempt.
Take tramadol exactly as prescribed. Follow all directions on your prescription label. Tramadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Tramadol may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away this medicine is against the law.
Stop taking all other around-the-clock narcotic pain medications when you start taking tramadol.
Tramadol can be taken with or without food, but take it the same way each time.
Do not crush, break, or open an extended-release tablet or capsule (ConZip, Ultram ER). Swallow it whole to avoid exposure to a potentially fatal dose.
Never crush or break a tablet inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.
Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat. Keep track of your medicine. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.
Since tramadol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tramadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow heart rate, severe drowsiness, cold and clammy skin, very slow breathing, or coma.
Do not drink alcohol. Dangerous side effects or death could occur.
This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Get emergency medical help if you have signs of an allergic reaction to tramadol (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Like other narcotic medicines, tramadol can slow your breathing. Death may occur if breathing becomes too weak.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
a slow heart rate or weak pulse;
a light-headed feeling, like you might pass out;
seizure (convulsions);
missed menstrual periods;
impotence, sexual problems, loss of interest in sex; or
nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common tramadol side effects may include:
constipation, nausea, vomiting, stomach pain;
dizziness, drowsiness, tiredness;
headache; or
itching.
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.
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Tramadol can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
other narcotic medications - opioid pain medicine or prescription cough medicine;
a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may interact with tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tramadol only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Tramadol Hcl (www.drugs.com/tramadol.html).
Commonly reported side effects of tramadol include: pruritus, agitation, anxiety, constipation, diarrhea, hallucination, nausea, tremor, vomiting, and diaphoresis. Other side effects include: insomnia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet extended release
Oral route (Tablet; Tablet, Extended Release; Capsule, Extended Release)
Addiction, Abuse, and MisuseTramadol hydrochloride 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 hydrochloride, and monitor all patients regularly for the development of these behaviors or conditions.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of tramadol hydrochloride. Monitor for respiratory depression, especially during initiation of tramadol hydrochloride or following a dose increase. Instruct patients to swallow tramadol hydrochloride extended release formulations intact, and not to cut, break, chew, crush, or dissolve the tablets to avoid exposure to a potentially fatal dose of tramadol.
Accidental IngestionAccidental ingestion of even one dose of tramadol hydrochloride, especially by children, can result in a fatal overdose of tramadol.
Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in ChildrenLife-threatening respiratory depression and death have occurred in children who received tramadol. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. Tramadol hydrochloride tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
Neonatal Opioid Withdrawal SyndromeProlonged use of tramadol hydrochloride 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.
Interactions with Drug Affecting Cytochrome P450 IsoenzymesThe effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant 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 hydrochloride 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.
Along with its needed effects, 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 tramadol:
Less common
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking tramadol:
Symptoms of overdose
Some side effects of 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:
More common
Less common
For Healthcare Professionals
Applies to tramadol: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release
GeneralThe most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.
PsychiatricCNS stimulation has been reported as a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations. 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, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).
Very common (10% or more): CNS stimulation (up to 14%)
Common (1% to 10%): Anxiety, euphoria, nervousness, sleep disorder, insomnia, depression, agitation, apathy, depersonalization
Uncommon (0.1% to 1%): Emotional lability
Rare (less than 0.1%): Hallucinations, nightmares, dependency
Very rare (less than 0.01%): Withdrawal syndrome
HypersensitivityRare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin
GastrointestinalVery common (10% or more): Nausea (up to 40%), constipation (up to 46%), vomiting (up to 17%), dyspepsia (up to 13%)
Common (1% to 10%): Dry mouth, diarrhea, abdominal pain, flatulence, sore throat, gastroenteritis viral
Uncommon (0.1% to 1%): Toothache, appendicitis, pancreatitis
Nervous systemEpileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.
Serotonin syndrome has been reported during concomitant use of opioids with serotonergic drugs.
Very common (10% or more): Dizziness (up to 28%), somnolence (up to 25%), headache (up to 32%),
Common (1% to 10%): Confusion, coordination disturbance, tremor, paresthesia, hypoesthesia
Uncommon (0.1% to 1%): Migraine, sedation, syncope, disturbance in attention
Rare (less than 0.1%): Epileptiform seizures
Postmarketing reports: Seizures
Opioids:
Postmarketing reports: Serotonin syndrome
DermatologicVery common (10% or more): Pruritus (up to 11%)
Common (1% to 10%): Sweating, rash, dermatitis
Uncommon (0.1% to 1%): Cellulitis, piloerection, clamminess, urticaria, toxic epidermal necrolysis, Stevens Johnson-syndrome, hair disorder, skin disorder
GenitourinaryCommon (1% to 10%): Menopausal symptoms, urinary frequency, urinary retention, urinary tract infection
Uncommon (0.1% to 1%): Difficulty in micturition, hematuria, dysuria, cystitis, sexual function abnormality
CardiovascularReports of QT prolongation and/or torsade de pointes have been received. 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.
Very common (10% or more): Flushing (up to 15.8%)
Common (1% to 10%): Vasodilation, postural hypotension, chest pain
Uncommon (0.1% to 1%): Palpitations, myocardial infarction, lower limb edema, peripheral swelling, hypertension, increased heart rate, peripheral ischemia, EKG abnormality, hypotension, tachycardia
Rare (less than 0.1%): Bradycardia
Postmarketing reports: QT prolongation/torsade de pointes
OtherVery common (10% or more): Asthenia (up to 12%)
Common (1% to 10%): Malaise, weakness, pain, feeling hot, influenza like illness, rigors, lethargy, pyrexia
Uncommon (0.1% to 1%): Tinnitus, vertigo, ear infection
MetabolicCommon (1% to 10%): Anorexia, decreased weight, increased blood glucose
Uncommon (0.1% to 1%): Gout
Rare (less than 0.1%): Changes in appetite
EndocrineVery rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion
Opioids:
Postmarketing reports: Adrenal insufficiency; androgen deficiency
HematologicUncommon (0.1% to 1%): Anemia, ecchymosis
HepaticUncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests
OcularCommon (1% to 10%): Miosis, visual disturbance, blurred vision
Uncommon (0.1% to 1%): Lacrimation disorder
Frequency not reported: Mydriasis
RenalUncommon (0.1% to 1%): blood urea nitrogen increased
MusculoskeletalCommon (1% to 10%): Hypertonia, arthralgia, back pain, limb pain, neck pain, muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, aggravated osteoarthritis
Uncommon (0.1% to 1%): Joint swelling, joint sprain, muscle injury, leg cramps
Rare (less than 0.1%): Involuntary muscle contractions
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Tramadol Hcl (www.drugs.com/tramadol.html).
October 19, 2020
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