Generic Name: tramadol (TRAM-a-dol)
Brand Names: Ultram®
Classification: Narcotic-Like Pain Reliever
Issue Date: 2001

Tramadol is a narcotic-like pain reliever. Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

You should not take tramadol if you have ever been addicted to drugs or alcohol.

Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day.

Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include:

• anxiety
• sweating
• nausea
• diarrhea
• tremors
• chills
• hallucinations
• trouble sleeping
• breathing problems

Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhilation or injection can cause life-threatening side effects, overdose, or death.

Seizures (convulsions) have occurred in some people taking tramadol. You may be more likely to have a seizure while taking tramadol if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, or medicine for nausea and vomiting.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. Symptoms of a tramadol overdose may include:

• drowsiness
• shallow breathing
• slow heartbeat
• extreme weakness
• cold or clammy skin
• feeling light-headed
• fainting
• coma

While you are taking tramadol, do not drink alcohol or use drugs that make you sleepy such as:

• cold medicine
• other pain medications
• muscle relaxants
• medicine for seizures, depression or anxiety

These drugs may slow your breathing or increase drowsiness when used together with tramadol. Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label. Do not take more than 300 milligrams of tramadol in one day.

Take each dose with a full glass of water. Tramadol can be taken with or without food, but take it the same way each time.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhilation or injection can cause life-threatening side effects, overdose, or death.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

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.

Tramadol may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor.

Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include:

• anxiety
• sweating
• nausea
• diarrhea
• tremors
• chills
• hallucinations
• trouble sleeping
• breathing problems

Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol. Store tramadol at room temperature away from moisture and heat.

You should not take tramadol if you have ever been addicted to drugs or alcohol. Do not take tramadol if you are intoxicated (drunk), or if you have recently used any of the following drugs:

• alcohol
• narcotic pain medicine
• sedatives or tranquilizers (such as Valium®)
• medicine for depression or anxiety
• medicine for mental illness (such as bipolar disorder, schizophrenia)
• street drugs

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have any of these conditions:

• history of drug or alcohol addiction
• history of epilepsy or other seizure disorder
• history of head injury
• metabolic disorder

Talk with your doctor about your individual risk of having a seizure from this medicine. Before taking tramadol, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease
• liver disease
• stomach disorder
• history of depression, mental illness, or suicide attempt

If you have any of these conditions, you may not be able to use tramadol, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tramadol may also cause SERIOUS or FATAL side effects in a NEWBORN if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of tramadol. If you are over 65, your doctor may Tramadol should not be given to a child younger than 16 years of age.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be FATAL. Symptoms of a tramadol overdose may include:

• drowsiness
• shallow breathing
• slow heartbeat
• extreme weakness
• cold or clammy skin
• feeling light-headed
• fainting
• coma

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Call your doctor at once if you have any of these SERIOUS side effects:

• seizure (convulsions)
• red, blistering, peeling skin rash
• shallow breathing, weak pulse

Continue taking tramadol and talk to your doctor if you have any of these less serious side effects:

• dizziness
• drowsiness
• weakness
• nausea
• vomiting
• constipation
• loss of appetite
• blurred vision
• flushing (redness, warmth, or tingly feeling)
• sleep problems (insomnia)

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following:

• isocarboxazid (Marplan®)
• tranylcypromine (Parnate®)
• phenelzine (Nardil®)
• selegiline (Eldepryl®, Emsam®)
• amitriptyline (Elavil®)
• citalopram (Celexa®)
• clomipramine (Anafranil®)
• desipramine (Norpramin®)
• escitalopram (Lexapro®)
• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• imipramine (Tofranil®)
• nortriptyline (Pamelor®)
• paroxetine (Paxil®)
• sertraline (Zoloft®)

Before taking tramadol, tell your doctor if you also use:

• carbamazepine (Tegretol®)
• warfarin (Coumadin®)
• digoxin (Lanoxin®, Lanoxicaps®)
• ketoconazole (Nizoral®)
• erythromycin (E-Mycin®, E.E.S.®, Ery-Tab®)
• rifampin (Rifadin®, Rimactane®, Rifater®)
• St. John's wort
• quinidine (Quinaglute®, Quinadex®, Cardioquin®, Quinora®)
• cold medicine
• pain medications
• muscle relaxants
• medicine for seizures, depression or anxiety

If you are using any of these drugs, you may not be able to use tramadol or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.