Tramadol

Tramadol is an opioid agonist that may be used to treat moderate to moderately severe chronic pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough, or you cannot tolerate them.

• Extended-release forms of tramadol may be used in adults who require around-the-clock treatment of their pain for an extended period.
• An opioid pain medicine such as tramadol can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Brands of tramadol include ConZip, Qdolo, Ryzolt, Ultram, Ultram ER, and Ultracet. Many have been discontinued, but generic tramadol is still available.

Taking tramadol in combination with other pain-relieving medicines such as acetaminophen, ibuprofen, or aspirin can provide better pain relief than just taking one pain-relieving medicine by itself (see Can you take tramadol in combination with acetaminophen, ibuprofen, or aspirin?)

Tramadol first gained FDA approval on March 3, 1995. Originally, it was classified as a non-controlled substance, but it was reclassified in 2014 to Schedule IV of the Controlled Substances Act with restrictions on its prescribing. Tramadol is an opioid (see Is tramadol an opioid?).

A person's genetics can affect the pain-relieving properties of tramadol (see How do genetics affect tramadol?).

Tramadol is used for the management of moderate to moderately severe pain in adults, including postoperative pain (pain after surgery).

Tramadol treats pain severe enough to require opioids and may be used as an alternative to other forms of pain relief that did not relieve pain well enough or were not tolerated.

Tramadol extended-release capsules may be used by adults who require around-the-clock treatment of their moderate to moderately severe chronic pain for an extended time.

Tramadol should not be used in children younger than 12 years old, or anyone younger than 18 years old with other risk factors (such as breathing problems), or who have recently had surgery to remove their tonsils or adenoids.

• Extended-release tramadol (Ultram ER) should not be given to anyone younger than 18 years.

Yes, tramadol is an opioid. The opioid activity of tramadol is due to its binding to mu-opioid receptors.

Do not change your dose. Take tramadol exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Tell your doctor if you feel an increased urge to take more of this medicine.

• For acute (short-term) pain, you may only need to take tramadol for a few days. You may have some tramadol left over that you did not use. See disposal information at the bottom of this section for directions on how to safely dispose of tramadol.
• Take your prescribed dose as indicated by your healthcare provider. Take your prescribed dose as indicated by your healthcare provider. After your dose has been settled, immediate-release tramadol is usually taken as 50 mg to 100 mg (one or two 50 mg tablets) every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose, and do not take more than 400 mg of tramadol in one day. For immediate-release tramadol, that is eight 50 mg tablets a day, taken in divided doses, or 80 mL of the 5 mg/mL oral solution. Extended-release tramadol has a lower daily limit of 300 mg, taken as one dose once a day. Always check the strength printed on your own bottle or packet. Do not take tramadol together with any other medicine that contains tramadol.
• If you miss a dose, take your next dose at your usual time.
• Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.
• Never crush or break a tramadol tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
• May be taken with or without food.

If you take the oral solution

Tramadol oral solution is measured in millilitres (mL), not milligrams (mg), and contains 5 mg of tramadol in every 1 mL. Confusing the two units can cause a fatal overdose. Always measure your dose with a graduated oral syringe or measuring cup marked in mL, which your pharmacy can supply, and never with a household teaspoon or tablespoon. If your prescription is written in milligrams, ask your pharmacist to confirm how many millilitres that is before you take your first dose.

Notes

You may have withdrawal symptoms if you stop using tramadol suddenly. Ask your doctor before stopping the medicine.

Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Do not keep leftover tramadol. Just one dose can cause death if someone uses it 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.

Call your healthcare provider if the dose you are taking does not control your pain.

If you have been taking tramadol regularly, do not stop taking tramadol without talking to your healthcare provider.

Get emergency help or call 911 right away if you take too many tramadol (overdose). When you first start taking tramadol, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking tramadol with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Do not take tramadol with any other medicine that contains tramadol. Check the label of every pain medicine you take, as some combination products contain tramadol.

You should be given a Medication Guide each time you fill a tramadol prescription. Read it every time, even if you have taken tramadol before, because the information may have changed. Your healthcare provider or pharmacist should also go through the risks of tramadol and how to take it safely with you, and explain what to do in an emergency.

Never give anyone else your tramadol. They could die from taking it. Selling or giving away tramadol is against the law.

Store tramadol securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take tramadol if you are:

• are allergic to tramadol, to any of the other ingredients in your product, or to other opioids
• have significant breathing problems (respiratory depression)
• have acute or severe asthma and are somewhere you cannot be monitored, or where resuscitation equipment is not available
• have a known or suspected blockage of the stomach or intestines, including paralytic ileus
• have taken a monoamine oxidase inhibitor (MAOI) in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine)
• are younger than 12 years of age
• are younger than 18 years of age and have recently had surgery to remove your tonsils or adenoids.

Seizures have occurred in some people taking tramadol. Your seizure risk may be higher if you have ever had:

• a head injury, epilepsy, or other seizure disorder
• drug or alcohol addiction or
• a metabolic disorder.

To make sure tramadol is safe for you, tell your doctor if you have a history of:

• Head injury or seizures
• Problems urinating
• Liver, kidney, or thyroid problems
• Pancrease or gallbladder problems, including pancreatitis or surgery on your pancreas
• A serious infection
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Also tell your doctor if you are dehydrated, are eating less or have changed your diet, are on a low-sodium (salt) diet, drink a lot of alcohol, or are planning to have surgery.

Tell your healthcare provider if you are:

• Living in a household where there are small children or someone who has abused street or prescription drugs
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol with certain other medicines can cause serious side effects that could lead to death
• Notice your pain getting worse. If your pain gets worse after you take tramadol, do not take more tramadol without first talking to your doctor. Talk to your doctor if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking tramadol.

Important Information Guiding Use in Pediatric Patients

• Do not give tramadol to a child younger than 12 years of age or extended-release tramadol to anyone under 18 years.
• Do not give tramadol to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving tramadol to children between 12 and 18 years of age who have risk factors for breathing problems. These include having recently had surgery, obstructive sleep apnea, obesity, severe lung disease, neuromuscular disease, and taking other medicines that can slow breathing.

Pregnancy

Tramadol may harm an unborn baby and is not usually recommended during pregnancy. Use of tramadol for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Neonatal seizures, neonatal withdrawal syndrome, fetal death, and stillbirth have all been reported. Tramadol is also not recommended during or immediately before labor. It should only be used in pregnancy if the benefits outweigh the risks. If you are already taking tramadol and become pregnant, do not stop taking it without talking to your healthcare provider, as stopping suddenly can be harmful to you both.

Breastfeeding

Breastfeeding is not recommended while taking tramadol, as it may harm your baby. Mothers who are ultra-rapid metabolizers of tramadol can have higher than expected levels of its active form in their breast milk, which can be dangerous for a breastfed infant. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.

Common side effects

The most common side effects of tramadol are:

• dizziness or vertigo
• nausea
• constipation
• headache
• drowsiness
• vomiting
• itching.

Dry mouth is also commonly reported with the extended-release forms of tramadol.

A person's genetics can affect their response to tramadol, including their risk of side effects (see How do genetics affect tramadol?).

Serious tramadol side effects and warnings

Tramadol may cause serious side effects, some of which may be fatal.

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. Keep this medicine where others cannot get to it. Do not take more tramadol than prescribed, as an overdose can be fatal. Selling or giving away this medicine is against the law.

• A person caring for you should give naloxone and seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you find it hard to wake up. Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.
• 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) or low cortisol levels (symptoms include nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness) low sodium levels (hyponatremia). Symptoms include headache, confusion, weakness, unsteadiness, or feeling sick low blood sugar (hypoglycemia). Symptoms include shakiness, sweating, hunger, confusion, or a fast heartbeat.

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.

Seizures have been reported in patients taking tramadol. Your risk of seizures is higher if you are taking higher doses than recommended. Seizure risk is also higher in those with epilepsy or a history of seizures, and in those taking certain antidepressants, other opioids, MAO inhibitors, or other medicines that lower the seizure threshold.

You should not take tramadol if you have significant breathing problems, acute or severe asthma in a setting where you cannot be monitored, a blockage in your stomach or intestines, or if you have taken an MAO inhibitor in the past 14 days (isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others). Tell your doctor before starting tramadol if you have a head injury or increased pressure inside your skull, as tramadol should be used with particular care in these situations.

Prescribers are advised not to prescribe tramadol for people who are suicidal or prone to addiction, and to use it with caution in people taking tranquilizers or antidepressants, or drinking heavily. If you are struggling with thoughts of harming yourself, or with your use of any medicine, tell your healthcare provider so they can help you find the right treatment and support.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. People taking extended-release forms of tramadol should not consume alcohol-containing beverages at the same time. Alcohol is also not advised with immediate-release forms of tramadol.

Serious allergic reactions, including anaphylaxis, have occurred with tramadol, some of which caused death. People who are allergic to other opioids are at higher risk. Other hypersensitivity reactions include itching, hives, narrowing of the airways, swelling of the face and airways (angioedema), and serious skin reactions such as Stevens-Johnson Syndrome. Get emergency medical help if you have signs of an allergic reaction to tramadol (symptoms include hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, a red or purple skin rash that spreads and causes blistering and peeling).

Tramadol may make pain worse rather than better in some people, an effect called opioid-induced hyperalgesia. Talk to your doctor if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking tramadol.

Tramadol extended-release capsules and tablets may complicate a healthcare provider’s clinical assessment of an acute abdominal condition. They are not recommended for people with severe liver or severe kidney impairment.

Taking tramadol during pregnancy may cause life-threatening withdrawal symptoms in the newborn, known as neonatal opioid withdrawal syndrome (NOWS).

Some people are “ultra-rapid metabolizers” of tramadol because of a variation in an enzyme called CYP2D6. Their bodies convert tramadol into its active form faster than usual, which can produce dangerously high opioid levels even at a normal dose. Life-threatening breathing problems and deaths have occurred in children for this reason, including after surgery to remove the tonsils or adenoids. Tramadol should not be given to a child younger than 12 years old, or to anyone younger than 18 years old who has recently had surgery to remove the tonsils or adenoids. Extended-release tramadol should not be given to anyone younger than 18 years.

Tramadol may cause drowsiness or affect your ability to drive or perform hazardous tasks. Do not perform these tasks if tramadol causes confusion, mental impairment, or drowsiness.

Tramadol can cause withdrawal symptoms if stopped suddenly after being taken for a long period of time. Symptoms may include restlessness, drug craving, anxiety, and sweating. Do not stop taking tramadol suddenly without talking to your healthcare provider, as stopping abruptly can cause serious withdrawal symptoms and uncontrolled pain (see How long does tramadol withdrawal last?).

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 the FDA at 1-800-FDA-1088.

Adult Tramadol Dosage for Pain

Immediate-release formulations (tablets and oral solution)

• Treatment usually starts at 25 mg a day, increasing by 25 mg every 3 days to reach 100 mg a day (25 mg four times a day). Doses of 25 mg are measured using the oral solution, as immediate-release tramadol tablets are only available as 50 mg.
• For the immediate-release tablets, a common starting dose is one 50 mg tablet a day to see how well you tolerate it, or the dose prescribed by your doctor.
• If needed, the total daily dose can then be increased by 50 mg every 3 days as tolerated, to reach 200 mg a day (one 50 mg tablet four times a day).
• After this titration, 50 mg to 100 mg (one or two 50 mg tablets) can be taken every 4 to 6 hours as needed for pain.
• The maximum is 400 mg a day: eight 50 mg tablets in divided doses, or 80 mL of the 5 mg/mL oral solution.

Extended-release capsules and tablets

• Tramadol ER 100 mg once a day (one 100 mg tablet or capsule) at approximately the same time each day.
• Can be increased by 100 mg every 5 days if needed, to a maximum of 300 mg a day, taken as one dose once a day.
• Extended-release tramadol is not intended for as-needed pain relief, and should not be taken with any other tramadol product.

Dosage in kidney or liver impairment

• Severe kidney impairment: for immediate-release tramadol, doses are spaced 12 hours apart, and the maximum is 200 mg a day (four 50 mg tablets, given as two 100 mg doses 12 hours apart).
• Severe liver impairment: for immediate-release tramadol, the recommended dose is 50 mg (one 50 mg tablet) every 12 hours, which is 100 mg a day.
• Extended-release tramadol is not recommended for people with severe kidney or severe liver impairment.

Dosage in older adults

• No separate maximum dose applies on the basis of age, but tramadol should be started at the low end of the dosing range and increased slowly, with frequent review for drowsiness and breathing problems.
• Side effects that led people to stop treatment were more common over the age of 75, mostly stomach and bowel effects, such as constipation. Kidney function also tends to decline with age, which affects how tramadol is cleared, so your doctor may take this into account when choosing your dose.

Since tramadol is used for pain, you are unlikely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activities until you know how tramadol will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tramadol is broken down by two liver enzymes called CYP3A4 and CYP2D6, and medicines that block or speed up these enzymes change how much tramadol and how much of its active form are in your body. Because starting one of these medicines and stopping one both shift the balance, tell your doctor whenever you begin or finish a course of an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Many other drugs can be dangerous when used with tramadol. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder
• other opioid medicines
• buprenorphine, butorphanol, nalbuphine, or pentazocine. These opioids work differently and can block tramadol's pain-relieving effect or bring on sudden withdrawal symptoms, so they are generally not taken with tramadol
• a benzodiazepine sedative like Valium, Klonopin, or Xanax
• sleep medicine, muscle relaxers, or other drugs that make you drowsy
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease
• carbamazepine, which is not recommended with tramadol because it can significantly reduce tramadol's pain-relieving effect and add to the risk of seizures
• digoxin or warfarin, which need extra monitoring when taken with tramadol.

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 here.

Store at room temperature away from moisture and heat and out of reach of children. Do not share with others.