Ultram ER Extended-Release Tablets

Generic Name: Tramadol (TRAM-a-dol)Brand Name: Examples include Ultram ER or Ryzolt

Ultram ER Extended-Release Tablets are used for:

Treating moderate to moderately severe chronic pain in certain patients.

Ultram ER Extended-Release Tablets are an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Ultram ER Extended-Release Tablets if:

  • you are allergic to any ingredient in Ultram ER Extended-Release Tablets
  • you have had a severe allergic reaction (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to codeine or other opioids (eg, morphine)
  • you are intoxicated with alcohol, other opioids or narcotics (eg, codeine, morphine), sedatives or sleeping medicines (eg, temazepam, zolpidem), or other medicines
  • you have severe liver or kidney problems
  • you are taking carbamazepine, nefazodone, sodium oxybate (GHB), a thioxanthene (eg, thiothixene), or another product that contains tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ultram ER Extended-Release Tablets:

Some medical conditions may interact with Ultram ER Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver, kidney, or thyroid problems; a blockage in the bladder; diabetes; heart problems; high blood pressure; prostate problems; or metabolism problems
  • if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
  • if you have a history of diarrhea caused by antibiotic use, recent stomach or bowel surgery, or any other stomach or bowel problems (eg, pain, inflammation, ulcers)
  • if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]) or a seizure disorder (eg, epilepsy)
  • if you are going through withdrawal from alcohol or other substances or if you have a history of alcohol or other substance abuse, mood or mental problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Ultram ER Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), linezolid, lithium, macrolide antibiotics (eg, erythromycin), nefazodone, quinidine, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan) because serotonin syndrome may occur
  • Anorexiants (eg, phentermine), buytrophenones (eg, haloperidol), certain medicines for mental or mood disorders (eg, olanzapine), cyclobenzaprine, furazolidone, loxapine, molindone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), other opioid pain medicine (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), sodium oxybate (GHB), thioxathenes (eg, thiothixene), or tiagabine, because the risk of side effects, including excessive drowsiness, trouble breathing, liver problems, or seizures, may be increased
  • Other products containing tramadol because they may increase the risk of Ultram ER Extended-Release Tablets's side effects
  • Rifampin because it may decrease Ultram ER Extended-Release Tablets's effectiveness
  • Carbamazepine because it may decrease Ultram ER Extended-Release Tablets's effectiveness; the risk of seizures may also be increased
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Ultram ER Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ultram ER Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ultram ER Extended-Release Tablets:

Use Ultram ER Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Ultram ER Extended-Release Tablets by mouth with or without food. Try to take it the same way (either with food or without food) each time you take your dose. Check with your doctor or pharmacist if you have questions about taking Ultram ER Extended-Release Tablets with food.
  • Swallow Ultram ER Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of Ultram ER Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ultram ER Extended-Release Tablets.

Important safety information:

  • Ultram ER Extended-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ultram ER Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ultram ER Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Ultram ER Extended-Release Tablets may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Tell your doctor or dentist that you take Ultram ER Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Ultram ER Extended-Release Tablets. Your risk may be greater if you take Ultram ER Extended-Release Tablets with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • Use Ultram ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, severe lightheadedness, and indigestion.
  • Ultram ER Extended-Release Tablets should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Ultram ER Extended-Release Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ultram ER Extended-Release Tablets while you are pregnant. Ultram ER Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Ultram ER Extended-Release Tablets.

When used for long periods of time or at high doses, Ultram ER Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ultram ER Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Ultram ER Extended-Release Tablets for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Ultram ER Extended-Release Tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Do not suddenly stop taking Ultram ER Extended-Release Tablets without talking with your doctor. If you need to stop Ultram ER Extended-Release Tablets, your doctor will lower your dose over time.

Possible side effects of Ultram ER Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat.

Proper storage of Ultram ER Extended-Release Tablets:

Store Ultram ER Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ultram ER Extended-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Ultram ER Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Ultram ER Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ultram ER Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Ultram ER Advanced Consumer (Micromedex) - Includes Dosage Information
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  • Ultram Prescribing Information (FDA)
  • Ultram Detailed Consumer Information (PDR)
  • Ultram Consumer Overview