Tramadol (Ultram®, Ultracet and Ultram® ER)

Sold under the brand name Ultram®, Ultracet and Ultram® ER (extended release), among others, tramadol is an opioid pain medicine used to treat moderate to moderately severe pain. It is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

A recent guideline from the American Geriatrics Society recommends that all older patients with moderate to severe osteoarthritis pain or diminished quality of life be considered for opioid therapy such as tramadol because the risks of NSAIDs in these patients, including cardiovascular risk and gastrointestinal toxicity, may be serious enough to outweigh the potential for addiction.

However, some studies have shown that for other patients not in this category, the benefits of tramadol are small and do not outweigh the potential for side effects. One review of several randomized clinical trials that evaluated the effect of tramadol on pain levels and/or physical function in people with OA found that “adverse events, although reversible and not life threatening, often cause participants to stop taking the medication and could limit tramadol usefulness.”

A more recent meta-analysis (a study that reviews many previous clinical studies) comparing oral NSAIDs and oral opioids for relief of knee OA pain in over 5,500 patients found that on average, oral NSAIDs, less potent oral opioids (such as tramadol) and more potent oral opioids (such as oxycodone) all reduced pain to a similar extent, by about 30 percent.

Why am I taking tramadol?

Your doctor may prescribe tramadol if you are not getting adequate symptom relief from OTC or prescription acetaminophen or an NSAID, or if are at high risk for gastrointestinal bleeding, which NSAIDs may cause in some people. You may also be taking tramadol because your arthritis pain and other symptoms are severe, or you are an older patient for whom the risks of an NSAID (such as gastrointestinal bleeding or kidney or heart problems) outweigh the risk of addiction and other side effects associated with tramadol.

What are the possible side effects of tramadol?

Common side effects of tramadol include dizziness, headache, drowsiness, nausea and vomiting, constipation, lack of energy, sweating and dry mouth. These effects can be mild, and go away on their own within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist. Tramadol can also cause more serious side effects, including:

• Serious breathing problems
• Fast heart rate
• High blood pressure
• Fever
• Reflexes that are stronger than normal
• Lack of coordination
• Diarrhea
• Agitation
• Hallucinations (seeing or hearing things that aren’t real)
• Coma
• Fainting, dizziness or confusion
• Long-lasting tiredness or muscle weakness

Tramadol has a risk of decreasing fertility in men and women, and increases the risk of and can worsen seizures, especially in patients who drink alcohol or are taking certain other medications such as other opioids or drugs for depression, psychosis or mood disorders. Tramadol can also lead to addiction and misuse, which can result in overdose and death. A physical dependence can lead to withdrawal symptoms if you stop taking the drug. These may include:

• Feeling irritable, anxious, or restless
• Trouble sleeping
• Increased blood pressure
• Fast breathing rate
• Fast heart rate
• Dilated (large) pupils
• Teary eyes
• Runny nose
• Yawning
• Nausea, vomiting, and a loss of appetite
• Diarrhea and stomach cramps
• Sweating
• Chills
• Muscle aches, back pain, or joint pain

Tramadol has the potential to interact with other drugs you may be taking, which could increase your risk for breathing problems, sedation, or coma. These drugs include those taken for anxiety, mental illness, nausea, pain, muscle relaxants, sedatives, sleeping pills or tranquilizers.

How to monitor for side effects

You and your doctor should be on the lookout for any of the above side effects, particularly any signs that you may be developing a dependency on the drug. If you have any of these, your doctor may need to adjust your dose or discontinue use. Even mild side effects that do not go away within a few weeks should be taken seriously and reported to your doctor. Do not attempt to adjust your dose or stop taking the drug on your own – talk to your doctor first.

What can I do to prevent or ease side effects of tramadol?

• Take this drug exactly as prescribed by your doctor to help avoid developing a dependence. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
• Do not drive or operate machinery until you know how tramadol will affect you.
• Do not stop taking tramadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tramadol, you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; pain; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations.
• Tell your doctor what herbal products you are taking, especially St. John’s wort and tryptophan.
• Tell your doctor if you have or have ever had slowed breathing, lung disease, or asthma. Your doctor may tell you not to take tramadol.
• Tell your doctor if you have or have ever had seizures; an infection in your brain or spine; a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull.
• Discuss any psychological problems you have now or have had in the past including depression or thoughts about harming or killing yourself.u Make sure your doctor is aware of how much alcohol you drink.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tramadol, call your doctor.
• Drinking grapefruit juice can interact with tramadol, so talk to your doctor before doing so.