MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Ultram ER 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.

Taking Ultram ER during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Ultram ER with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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

• severe asthma or breathing problems;

• a blockage in your stomach or intestines;

• 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, rasagiline, selegiline, or tranylcypromine).

Ultram ER 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 Ultram ER to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking Ultram ER. Talk with your doctor about your seizure risk, which 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:

• liver or kidney disease;

• urination problems;

• problems with your gallbladder, pancreas, or thyroid;

• a stomach disorder; or

• mental illness, or suicide attempt.

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).

This medicine can slow or stop your breathing, and death may occur. A person caring for you should 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;

• 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 side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• constipation, nausea, vomiting, stomach pain;

• dizziness, drowsiness, tiredness;

• headache; or

• itching.