Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release capsules or tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain.

When tramadol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of acetaminophen and codeine combination. This medicine should come with a Medication Guide. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle it. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release capsule, extended-release tablet, and tablet whole with liquids. Do not break, crush, chew, snort, or inject it.

Along with its needed effects, a medicine 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:

Less common

Abnormal or decreased touch sensation

blisters under the skin

bloating

blood in the urine

blood pressure increased

blurred vision

change in walking and balance

chest pain or discomfort

chills

dark urine

difficult urination

dizziness or lightheadedness when getting up from a lying or sitting position

fainting

fast heartbeat

frequent urge to urinate

gaseous abdominal or stomach pain

indigestion

irregular heartbeat

loss of memory

numbness and tingling of the face, fingers, or toes

pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion

pain or discomfort in the arms, jaw, back, or neck

pains in the stomach, side, or abdomen, possibly radiating to the back

pale, bluish-colored or cold hands or feet

recurrent fever

seeing, hearing, or feeling things that are not there

seizures

severe cramping

severe nausea

severe redness, swelling, and itching of the skin

stomach fullness

sweating

swelling of the hands, ankles, feet, or lower legs

trembling and shaking of the hands or feet

trouble performing routine tasks

weak or absent pulses in the legs

yellow eyes or skin

Incidence not known

Agitation

confusion

cough

darkening of the skin

diarrhea

difficulty swallowing

dizziness

fever

hives, itching, skin rash

irregular heartbeat, recurrent

loss of appetite

mental depression

nausea

overactive reflexes

poor coordination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

shivering

talking or acting with excitement you cannot control

tightness in the chest

twitching

unusual tiredness or weakness

vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

decreased awareness or responsiveness

difficulty with breathing

lack of muscle tone

lightheadedness

loss of consciousness

pinpointed pupils of the eyes

severe sleepiness

slow or irregular heartbeat

unusual tiredness

Some side effects 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

Constipation

discouragement

drowsiness

dry mouth

feeling of warmth

feeling sad or empty

feeling unusually cold

general feeling of discomfort or illness

headache

heartburn

irritability

itching or skin rash

joint pain

loss of interest or pleasure

loss of strength or weakness

muscle aches and pains

redness of the face, neck, arms, and occasionally, upper chest

runny nose

sleepiness or unusual drowsiness

sore throat

stomach pain

stuffy nose

tiredness

trouble concentrating

unusual feeling of excitement

weakness

Less common

Abnormal dreams

appetite decreased

back pain

bladder pain

blistering, crusting, irritation, itching, or reddening of the skin

bloody or cloudy urine

body aches or pain

change in hearing

clamminess

cough producing mucus

cracked, dry, or scaly skin

decreased interest in sexual intercourse

difficult, burning, or painful urination

difficulty with moving

disturbance in attention

ear congestion

ear drainage

earache or pain in the ear

excessive gas

falls

false or unusual sense of well-being

feeling hot

feeling jittery

general feeling of bodily discomfort

goosebumps

headache, severe and throbbing

hoarseness

inability to have or keep an erection

itching, pain, redness, swelling, tenderness, or warmth on the skin

joint sprain, stiffness, or swelling

loss in sexual ability, desire, drive, or performance

loss of voice

lower back or side pain

muscle aching or cramping

muscle injury

muscle pain, stiffness, spasms, or twitching

nasal congestion

neck pain

night sweats

pain in the limbs

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

skin discoloration

trouble in holding or releasing urine

trouble with sleeping

weight increased or decreased

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check your or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment to make sure the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with tramadol may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

Children younger than 12 years of age.
Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).
If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine:

Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your doctor or dentist gives you certain medicines without knowing that you have been taking tramadol.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include: convulsions (seizures), difficult or troubled breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble breathing.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.