Tramadol

(tram-uh-dole)

Trade/other name(s): Ryzolt extended release, Ultracet, Ultram, Ultram ER, tramadol with acetaminophen

Why would this drug be used?

Tramadol is used to treat moderate to moderately severe pain.

How does this drug work?

Tramadol is a man-made (synthetic) opioid pain reliever, similar to morphine. It binds to opioid receptors in the brain and central nervous system (CNS), reducing the perception of pain as well as the emotional response to pain. There may be other ways in which this drug helps with pain that are not fully understood.

Before taking this medicine

Tell your doctor…

• If you are allergic to anything, including medicines, dyes, additives, or foods.
• If you have any medical conditions such as kidney disease, liver disease (including hepatitis), low thyroid function, or Addison's disease (low adrenal function). These conditions may require that your medicine dose, regimen, or timing be changed.
• If you have had abdominal pain or any disorder involving slowed or blocked intestines, such as paralytic ileus. Tramadol can worsen this problem.
• If you have trouble passing urine, narrow urethra, or if you have an enlarged prostate. Tramadol can make it harder to urinate.
• If you have ever had a seizure, head injury, or if you have had problems with pressure, infection, or a tumor in your head or brain. Tramadol can raise your risk of seizures.
• If you have low blood pressure. Tramadol can worsen this.
• If you have asthma, emphysema, chronic bronchitis, sleep apnea, or other breathing problem. Tramadol can make it worse.
• If you have taken monoamine oxidase inhibitors within the past 2 weeks (see drug interactions section, below.) Tramadol can cause coma, slow or shallow breathing, low blood pressure, excitability, seizures, or shock.
• If you are taking any medicine for depression or mental or emotional illness. Tramadol may cause serious side effects when taken with some of these drugs.
• If you drink alcohol or take any medicine that can affect your brain or nervous system. These may worsen the side effects of tramadol or cause other problems. The manufacturer recommends that people on tramadol not drink any alcohol during treatment.
• If you have trouble with addiction, alcohol, or drug abuse now or have had one in the past. Tramadol can be habit forming, especially for those who have had problems before.
• If you have or have had a serious mental illness such as depression, or thoughts of suicide.
• If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. There may be an increased risk of harm to the fetus if a woman takes this drug during pregnancy, especially later in pregnancy.
• If you are breast-feeding. The drug passes into breast milk and may affect the baby.
• About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Selective serotonin reuptake inhibitors such as may increase the risk of seizures and other harmful effects while taking tramadol.

These drugs may cause tramadol to build up in the body and increase the risk of serious effects:

• ketoconazole, an anti-fungal drug
• erythromycin, an antibiotic
• quinidine, a drug for heart rhythm
• the antidepressants fluoxetine, paroxetine, amitriptyline, and bupropion
• medicines to reduce the appetite

Antidepressants of the older MAO inhibitor type such as phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan), or selegiline (Emsam) may cause coma, slow or shallow breathing, low blood pressure, excitability, seizures, or shock if methadone is given within 2 weeks of the last MAO inhibitor dose.

Medicines or substances that slow down the brain or nervous system, such as these, can cause worse side effects if taken while being treated with tramadol:

• anti-anxiety drugs (tranquilizers or sedatives)
• sleeping pills
• muscle relaxers
• barbiturates
• anti-seizure medicines
• other opioid drugs
• anesthetics
• tricyclic antidepressants such as amitriptyline, desipramine, doxepin, imipramine, nortriptyline
• serotonin antidepressants such as fluoxetine (Prozac), paroxetine (Paxil), and Duloxetine (Cymbalta), venlafaxine (Effexor), sertraline (Zoloft), citalopram (Celexa), and others
• anti-psychotic drugs (drugs for mental illness)
• certain anti-nausea medicines
• alcohol

Some of these can cause slowed breathing, seizures, low blood pressure, extreme sleepiness, coma, or even death if taken with tramadol. You may need a different drug, or your doctor may need to adjust your medicine doses and watch you closely while you are on tramadol.

Certain drugs may raise your risk of a serious effect known as serotonin syndrome (with symptoms such as nausea, vomiting, diarrhea, headache, restlessness, and confusion) if taken with tramadol:

• most antidepressants
• linezolid (an antibiotic)
• migraine or cluster headache drugs (triptans), such as sumatriptan (Imitrex), rizatriptan (Maxalt), naratriptan (Amerge), eletriptan (Relpax), frovatriptan (Frova), almotriptan (Axert), zolmitriptan (Zomig)
• St. John's wort (a dietary supplement)

The following may decrease the effects of tramadol:

• carbamazepine (an anti-seizure drug)
• rifampin (a TB drug)
• St. John's wort (a dietary supplement)

The actions of digoxin (heart medicine) and warfarin (blood thinner) may be affected by tramadol. Your doctor may want to test your blood more often and watch you more closely.

Other medicines may affect and be affected by tramadol. Check with your doctor, nurse, or pharmacist about whether other medicines, vitamins, herbs, and supplements you are taking can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

The short-acting form of tramadol is usually taken 3 or 4 times a day to help control pain. It may also be taken when you notice pain, on an "as needed" basis, with some limits. Ask your doctor how many pills you can take in a 24-hour period, and how far apart you should take them. It is important not to take tramadol more often or use a larger amount than the doctor prescribes.

Tramadol also comes in a long-acting form, which contains a larger amount of the drug that is released slowly in the intestine. This pill is usually taken only once a day, and must be swallowed whole. Do not break, split, crush, chew, or dissolve these tablets. They contain enough tramadol to last for 24 hours. If they are chewed, dissolved, or crushed, the entire dose can be absorbed by the body all at once, causing overdose symptoms including serious effects and even death.

Your doctor may recommend that you start with a low dose and then increase it every few days, to reduce your risk of side effects. Take pills with a full glass of water, with or without food.

Your dose will depend on how much is needed to control your pain. Take this drug exactly as directed by your doctor. If you do not understand the instructions, ask your doctor or nurse to explain them to you.

Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children, pets, or others. Do not share your medicines with others. Medicine that will not be used should be flushed down the toilet as soon as possible.

Precautions

This medicine can cause drowsiness and lightheadedness. Do not drive, operate machinery, or perform other activities that require alertness until you know how you react to this medicine.

Tramadol can make you feel dizzy or faint, and increase your risk of falling. Be careful getting up, changing position, or walking. Get up slowly and hold onto something or someone to keep you steady. If you feel lightheaded or dizzy, it may help to lie down. It is best to have a responsible adult with you for the first few days after starting the tramadol and after any increase in dose, until you know how you will respond to it.

If you notice trouble breathing, itchy skin welts, sudden dizziness, or swelling of the face, mouth, or throat, get emergency help.

Rarely, serious skin rashes can happen while taking tramadol. This may start with flu-like symptoms, including fever. Call your doctor or nurse right away if you notice any skin rash, blisters, or sores inside the mouth, nose, or throat.

Call your doctor right away if you get short of breath, dizzy, faint, confused, or very drowsy. These may be signs your dose is too high, or you could have gotten an accidental overdose of the medicine.

Tell your doctor or nurse right away if you have trouble passing your urine, trouble walking, seizures, or other problems.

If you are having any kind of surgery or medical procedure, be sure to tell the doctor or dentist in charge that you are using this medicine.

Since tramadol affects the central nervous system, do not take other drugs or substances that slow down the brain or nervous system such as alcohol, sedatives, muscle relaxers, and sleeping medicines unless your doctor tells you to do so.

Constipation is a very common side effect of taking opioid pain medicines. While you're taking tramadol, you should take medicines such as stool softeners, bulk-forming agents, and/or laxatives as needed to have regular (daily) bowel movements. Talk to your nurse or doctor about this when you first start this medicine. Drink plenty of fluids throughout the day, and try to eat foods high in fiber such as whole grains, bran, fruits, and vegetables. Call your doctor or nurse right away if you have not moved your bowels in 2 days.

Most cancer pain can be controlled. Keep your doctor or nurse informed about how well your pain medicines are working and any side effects you are having. Your cancer team may need to adjust your medicines several times before they find the medicines that work best for you.

If you have chronic (long term) cancer pain, talk with your doctor about taking your pain medicines on a regular schedule to keep it from worsening. If you wait until the pain is bad, it takes more medicine to get it under control. If pain comes back between doses, talk to your cancer team about changing your medicine or adding an extra one for "breakthrough" pain.

Talk to your doctor or nurse about using the smallest effective dose to reduce side effects and the development of tolerance and physical dependence. Tolerance means that larger doses are needed to get the same pain relief. Physical dependence means that the body goes into withdrawal if drug is suddenly stopped. Both happen normally when strong (opioid) medicines are taken over several weeks to treat chronic pain. But this is different from addiction, which starts when the drug is taken for pleasure rather than for pain relief. Tell your doctor or nurse if you still have pain even though you are taking the medicine as directed. Do not adjust your dose without talking to your doctor or nurse.

Do not stop taking this medicine without talking to your doctor or nurse. When no longer needed, this medicine should be stopped gradually with the help of your doctor. If it is stopped suddenly, withdrawal symptoms may occur, such as restlessness, anxiety, runny nose, watering eyes, yawning, sweating, chills, gooseflesh, aches and pains, nausea, diarrhea, poor appetite, high blood pressure, or fast heartbeat. Rarely, it can cause numbness or tingling, hallucinations, or panic.

Acetaminophen or aspirin may be taken along with tramadol to increase the pain relief action. Some tramadol formulas, such as Ultracet and some generic forms, already have acetaminophen in the tablets. It is important to know if your medicines contain either of these drugs, and whether they are in other medicines you use. They are in many other remedies and it is easy to accidentally get too much of them. Check with your doctor, nurse, or pharmacist to find out if these drugs are included in any of your daily medicines.

This drug is a controlled substance, and may be habit forming. Do not allow others to take your medicine. A person who has taken tramadol for some time often needs large doses for pain relief, while the same amount could quickly kill someone else.

If you think you or someone else may have taken an overdose of tramadol, get emergency help right away. Symptoms of tramadol overdose may include extreme drowsiness, slow heart beat, slow or irregular breathing, cold clammy skin, or coma. Tramadol overdose may cause the heart or breathing to stop. If you are taking a tramadol preparation that includes acetaminophen, there may be other symptoms as well, and special treatment is usually required. See the information on acetaminophen for more details. With time-released tramadol it can take up to a day for all the medicine to absorb. The person may need to be observed for some time after treatment.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

• constipation*
• drowsiness*
• weakness
• nausea
• dizziness, lightheadedness*
• dry mouth
• headache

Less common

• vomiting
• changes in mood, such as anxiety, nervousness, depression
• mental clouding, confusion*
• slow or shallow breathing*
• low blood pressure when sitting or standing up*
• delayed digestion

Rare

• trouble urinating
• sweating
• tremors
• trouble sleeping
• poor appetite
• fainting*
• serious skin rash or blistering, sores in the mouth, eyes, or nose*
• seizures*
• allergic reaction, which may include itching, skin welts, trouble breathing, dizziness, or swelling of the face, mouth, or throat*

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1995.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.