Ultram ER is an pain medicine similar to an opioid. This medicine 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.

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

MISUSE OF Ultram ER CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Ultram ER should not be given to a child younger than 12 years old, or anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids. 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 may occur if you use also use alcohol or other drugs that cause drowsiness or slow breathing.

Follow the directions on your prescription label and read all medication guides. Never use Ultram ER in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of Ultram ER.

Never share Ultram ER with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Stop taking all other opioid medications when you start taking Ultram ER.

Ultram ER can be taken with or without food, but take it the same way each time.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Never crush or break a Ultram ER pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

You may have withdrawal symptoms if you stop using Ultram ER suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover Ultram ER. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

You should not take Ultram ER 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).

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. 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 Ultram ER 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 Ultram ER if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since Ultram ER is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

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

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

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).

Ultram ER 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.

Ultram ER may cause serious side effects. 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 of Ultram ER 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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Many other drugs can be dangerous when used with Ultram ER. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Other drugs may affect Ultram ER, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Many other drugs can be dangerous when used with Ultram ER. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy;

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Many other drugs may affect Ultram ER. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.