Ultram (tramadol) Overview
Ultram (tramadol) Dosage
How well Ultram works
Ultram (tramadol) Uses
Ultram (tramadol) Side Effects
Precautions & Warnings
Pregnancy & Nursing
Introduction to Ultram and Ultram ER Efficacy
Ultram and Ultram ER have been extensively studied to receive approval by the Food and Drug Administration for use in the United States. Like all prescription medications, Ultram and Ultram ER had to be evaluated for how well they work for their intended use in relation to the number and types of side effects. Only you and your doctor can determine together if taking Ultram or Ultram ER provides enough benefit to outweigh any potential risks.
Studies Show that Ultram Works to Treat Pain
Ultram has been shown to work in medium numbers of people in at least 3 studies prior to getting approved for use in the United States. These studies looked at the effect the drug had on pain following surgical procedures.
Ultram Efficacy for Pain
Ultram has been taken in doses of 50, 75 and 100 mg for pain following surgical procedures and oral surgery.
Doses of 100 mg of Ultram provided better pain relief compared with codeine sulfate (60 mg), but it was not as effective as the combination of aspirin (650 mg) with codeine phosphate (60 mg).
Ultram has been studied in 3 medium-sized, long-term trials. People with a variety of chronic painful conditions were studied for one to three months. Average daily doses of approximately 250 mg of Ultram in divided doses were generally equal to:
- 5 doses of acetaminophen (300 mg) with codeine phosphate (30 mg)–also known as Tylenol® with Codeine #3–daily
- 5 doses of aspirin (325 mg) with codeine phosphate (30 mg) daily
- 2 to 3 doses of acetaminophen (500 mg) with oxycodone hydrochloride (5 mg)–also known asTylox®–daily.
Ultram ER Efficacy for Pain
Ultram ER was studied in people with chronic, moderate to moderately severe pain due to osteoarthritis and/or low back pain. In order to participate in these studies, people were required to have moderate to moderately severe pain.
The effectiveness of Ultram ER was proven in the following two studies:
In one 12-week study, people with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip took doses of 100 mg to 400 mg daily.
Between 51% and 59% of people taking Ultram completed the study and 56% of people taking placebo (a sugar pill containing no medicine) completed the study. People who stopped taking Ultram ER due to side effects were more common in the groups taking Ultram ER in doses of 200 mg, 300 mg and 400 mg (20%, 27%, and 30% of people stopped, respectively) compared to 14% of the people taking Ultram ER 100 mg and 20% of people taking placebo.
People taking 100 mg and 200 mg of Ultram showed significant pain relief compared to people taking a placebo.
In one 12-week trial of Ultram ER in people with osteoarthritis of the knee, people increased doses to an average daily Ultram ER dose of approximately 270 mg/day.
A total of 49% of people taking Ultram ER completed the study, while 52% of people taking placebo completed the study. Most of the people who stopped taking Ultram ER did so because of the side effects. Most of the people who stopped taking placebo did so because the placebo had no effect on their pain.
People taking Ultram ER showed significant pain relief compared with people taking placebo.
Ultram Use in Children:
The safety and efficacy of Ultram in children under 16 years of age have not been established. The use of Ultram in children is not recommended.
Ultram Use in Older Adults
Older adults should consider a lower Ultram starting dose due to greater frequency of liver, kidney and heart problems and the increase in other existing conditions existing and medications taken. If you are over 75 years old your dose should not exceed 300 mg per day.
Deciding if Ultram or Ultram ER is Right for You
Ultram and Ultram ER have been used effectively by millions of consumers in the United States. Only a physician can decide if Ultram or Ultram ER is right for you, but you should understand the potential benefits and risks of taking this medicine. If you are taking Ultram or Ultram ER and have any concerns, be sure to speak with your doctor. Never stop taking any medicine without your doctor’s advice.
Written & reviewed by: Lisa Erwin R.Ph. CGP | Last review date: Dec 2010. Click the References Link below for a complete list of references.