Tramadol is an pain medicine similar to an opioid. Tramadol is used to treat moderate to severe pain.

The extended-release form of tramadol is for around-the-clock treatment of pain. This form of tramadol is not for use on an as-needed basis for pain.

Tramadol may also be used for purposes not listed in this medication guide.

You should not take tramadol if you are allergic to it, or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus);
• 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, 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 tramadol to anyone younger than 18 years old who recently had surgery to remove the 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.

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.

If you use tramadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Ask a doctor before using tramadol if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Ultram ER (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (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).

Tramadol can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or 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); or
• low cortisol levels--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 breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common 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.

Do not drink alcohol. Dangerous side effects or death could occur.

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