Ultram ER

To review how tramadol compares to other pain medications, please refer to this information.

• Tramadol vs. Oxycodone
• depression
• Tramadol vs. Hydrocodone
• Tramadol vs. Vicodin

• Tablets (immediate release): 50 mg.
• Tablets (extended release): 100, 200, and 300 mg.
• Capsule (extended release): 100, 200, 300 mg.

Tramadol should be store at room temperature, 15 C to 30 C (59 F to 86 F). It should be stored in a sealed container.

Ultram, Ultram ER, and Conzip are the current brand names available for tramadol in the US. Discontinued brands include Rebix OTD, and Ryzolt.

Tramadol is available in generic form, and you need a prescription for it from your doctor or other health care professional.

The FDA approved tramadol in March 1995.

Ultram ER is a prescription medication used to treat moderate to moderately severe pain in adults. Ultram ER belongs to a group of drugs called opioid analgesics, which work by blocking pain signals in the body.

Ultram ER comes in extended-release tablet and is taken once a day, with or without food. Do not chew, divide, or break Ultram ER tablets. Swallow the tablets whole.

Common side effects of Ultram ER include nausea, constipation, dry mouth, and fatigue. Ultram ER can also cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Ultram ER affects you.

Serious side effects have been reported with Ultram ER including the following:

• seizures. Tell your healthcare provider right away if you have some or all of the following symptoms of seizures:
  • body convulsions (shaking and trembling)
  • temporary loss of consciousness
• serotonin syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of serotonin syndrome:
  • hallucinations
  • fast heart rate
  • overactive reflexes
  • high blood pressure
  • restlessness or agitation
  • nausea or vomiting
  • decline in muscle coordination
  • rise in body temperature
• discontinuation symptoms. Do not stop Ultram ER without first talking to your healthcare provider. Stopping Ultram ER suddenly may cause serious symptoms including the following:
  • anxiety
  • sweating
  • insomnia
  • shaking or shivering
  • pain
  • nausea
  • diarrhea
  • upper airway symptoms
  • goose bumps
  • rarely hallucinations

Ultram ER can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Ultram ER affects you.

Limit your intake of alcohol while you take this medication. 

Do not take Ultram ER if you:

• are allergic to Ultram ER or any of its ingredients
• have a history of respiratory depression in unmonitored settings or the absence of corrective measures
• have a history of acute or chronic bronchial asthma or hypercapnia in unmonitored settings or the absence of corrective measures

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ultram ER, there are no specific foods that you must exclude from your diet when receiving Ultram ER.

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with (drug) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, swelling of your hands, face, or mouth, or chest pain while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures), difficult or troubled breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble breathing.

Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

• It is used to ease pain.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Very bad dizziness or passing out.
• Feeling confused.
• Seizures.
• Feeling very tired or weak.
• Chest pain or pressure or a fast heartbeat.
• Trouble passing urine.
• Passing urine more often.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Change in eyesight.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Extended-release tablets are available as:

100 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “100” over “ER” on one side in black ink

200 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “200” over “ER” on one side in black ink

300 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “300” over “ER” on one side in black ink

Clinical Trial Experience

Ultram ER was studied in patients with chronic, moderate to moderately severe pain due to osteoarthritis and/or low back pain in four 12‑week, randomized, double-blind, placebo-controlled trials. To qualify for inclusion into these studies, patients were required to have moderate to moderately severe pain as defined by a pain intensity score of ≥40 mm, off previous medications, on a 0 to 100 mm visual analog scale (VAS). Adequate evidence of efficacy was demonstrated in the following two studies:

In one 12-week randomized, double-blind, placebo-controlled study, patients with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip were administered doses from 100 mg to 400 mg daily. Treatment was initiated at 100 mg QD for four days then increased by 100 mg per day increments every five days to the randomized fixed dose. Between 51% and 59% of patients in the Ultram ER treatment groups completed the study and 56% of patients in the placebo group completed the study. Discontinuations due to adverse events were more common in the Ultram ER 200 mg, 300 mg and 400 mg treatment groups (20%, 27%, and 30% of discontinuations, respectively) compared to 14% of the patients treated with Ultram ER 100 mg and 10% of patients treated with placebo.

Pain, as assessed by the WOMAC Pain subscale, was measured at 1, 2, 3, 6, 9, and 12 weeks and change from baseline assessed. A responder analysis based on the percent change in WOMAC Pain subscale demonstrated a statistically significant improvement in pain for the 100 mg and 200 mg treatment groups compared to placebo (see Figure 2).

Figure 2

Study 2: Osteoarthritis of the Knee

In one 12-week randomized, double-blind, placebo-controlled flexible-dosing trial of Ultram ER in patients with osteoarthritis of the knee, patients titrated to an average daily Ultram ER dose of approximately 270 mg/day. Forty-nine percent of patients randomized to Ultram ER completed the study, while 52% of patients randomized to placebo completed the study. Most of the early discontinuations in the Ultram ER treatment group were due to adverse events, accounting for 27% of the early discontinuations in contrast to 7% of the discontinuations from the placebo group. Thirty-seven percent of the placebo-treated patients discontinued the study due to lack of efficacy compared to 15% of Ultram ER-treated patients. The Ultram ER group demonstrated a statistically significant decrease in the mean VAS score, and a statistically significant difference in the responder rate, based on the percent change from baseline in the VAS score, measured at 1, 2, 4, 8, and 12 weeks, between patients receiving Ultram ER and placebo (see Figure 3).

Figure 3