Ultram ER

Ultram ER is used to treat moderate to severe pain.

The extended-release form of tramadol is for treating severe pain continuously throughout the day and follows a daily dosing schedule. This form of tramadol is not meant to be used as needed.

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

Follow the instructions on your prescription label and read all medication guides or instruction sheets. Never use Ultram ER in larger amounts or for longer than prescribed. Let your doctor know if you feel a stronger urge to use more of Ultram ER.

Never share Ultram ER with anyone else, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine out of reach of others. Selling or giving away this medicine is illegal.

Do not change your dose or stop using Ultram ER without your doctor's advice. Consult a doctor before using any other opioid medications for pain management.

You can take Ultram ER with or without food, but make sure to take it the same way each time.

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

Use the measuring device provided to measure liquid medicine (not a kitchen spoon).

Never crush or break an Ultram ER pill to inhale the powder or mix it into a liquid for injection. This practice has led to death.

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

Store at room temperature, away from moisture and heat. Keep your medicine in a secure location where no one can misuse it.

Do not keep leftover medicine. Just one dose can be fatal for someone who accidentally or improperly uses it. Ask your pharmacist about a drug take-back program. Alternatively, you may mix leftover medicine with cat litter or coffee grounds in a sealed plastic bag and dispose of the bag in the trash.

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

Fatal side effects may occur if you also use alcohol or other drugs that cause drowsiness or slow breathing.

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 this medicine to anyone between 12 and 18 years old who has a risk of breathing problems such as obstructive sleep apnea, obesity, or lung problems.

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 risk of seizures may be higher if you have ever had:

• depression, a mental illness, head injury, epilepsy, or other seizure disorder;
• an opioid overdose, or a drug or alcohol addiction; or
• a metabolic disorder.

Tell your doctor if you have or have ever had:

• urination, gallbladder, pancreas, or thyroid problems;
• a stomach disorder;
• breathing problems, sleep apnea, mental illness, or suicide attempt; or
• liver or kidney disease.

May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. 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.

Do not breastfeed. Ultram ER in breast milk can cause life-threatening side effects in a nursing baby.

Long-term use of Ultram ER may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

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 eyes, skin pain, red or purple skin rash with blistering and peeling).

Ultram ER can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. 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:

• headache, hunger, weakness, sweating, irritability, dizziness, fast heart rate, or feeling jittery;
• increased sensitivity to pain or if your pain gets worse;
• seizure (convulsions), confusion, problems with thinking or memory, weakness, feeling unsteady;
• 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; or
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

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.

Common side effects of Ultram ER may include:

• itching, constipation, nausea, vomiting, stomach pain; or
• dizziness, drowsiness, tiredness, headache.

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.

Since Ultram ER is used for pain, you are unlikely to miss a dose. If you do miss a dose and it is almost time for your next dose, skip the missed dose. Do not use two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or anyone taking Ultram ER without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may suggest that 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 do not wake up. Your caregiver must still seek emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

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

Do not drink alcohol or any products that contain alcohol. Dangerous side effects or death could occur.

Avoid driving or doing hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can lead to falls, accidents, or severe injuries. Also, avoid standing up too quickly from a sitting or lying position, or you may feel dizzy.

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;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• other opioid medicines, 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. 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.