Is tramadol a risky pain medication?

Robert H. Shmerling, MD

Faculty Editor, Harvard Health Publishing

All medications come with a dose of risk. From minor side effects to life-threatening allergic reactions, every decision to take a medication should be made only after the expected benefits are weighed against the known risks. You aren’t on your own in this: your doctor, your pharmacist, and a trove of information are available for your review. Recently, I wrote about how newly approved drugs often accumulate new warnings about their safety, including a gout medication that garnered a new warning due to an increased risk of death. Now, according to a new study, the common prescription pain medication tramadol may earn a similar warning.

Tramadol is unique

When first approved in 1995, tramadol was not considered an opiate (like morphine or oxycodone) even though it acted in similar ways. However, because there were cases of abuse and addiction with its use, the thinking and warnings changed. In 2014, the FDA designated tramadol as a controlled substance. This means that although it may have accepted use in medical care, it also has potential for abuse or addiction and therefore is more tightly regulated. For example, a doctor can only prescribe a maximum of five refills, and a new prescription is required every 6 months.

Compared with other controlled substances, tramadol is at the safer end of the spectrum. Heroin, for example, is a Schedule I drug (high abuse potential and no acceptable medical use). OxyContin is a Schedule II drug (it also has high abuse potential, but has an accepted medical use). Classified as a Schedule IV drug, tramadol is considered useful as a pain reliever with a low potential for abuse.

Despite these concerns, tramadol is one of many common treatments recommended for osteoarthritis and other painful conditions. Several professional societies, including the American Academy of Orthopaedic Surgeons, include it in their guidelines as a recommended drug for osteoarthritis.

New research on tramadol

Researchers publishing in the medical journal JAMA examined the risk of death among nearly 90,000 people one year after filling a first prescription for tramadol or one of several other commonly recommended pain relievers, such as naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), or codeine. All participants were at least 50 years old and had osteoarthritis.

Those prescribed tramadol had a higher risk of death than those prescribed anti-inflammatory medications. For example:

  • naproxen: 2.2% of the tramadol group died vs. 1.3% of the naproxen group
  • diclofenac: 3.5% of the tramadol group died vs. 1.8% of the diclofenac group
  • etoricoxib: 2.5% of the tramadol group died vs. 1.2% of the etoricoxib group.

Meanwhile, people treated with codeine had a similar risk of death to people treated with tramadol.

However, because of the study’s design, the researchers could not determine whether tramadol treatment actually caused the higher rates of death. In fact, the patients for whom tramadol is prescribed could make it look riskier than it truly is.

What is confounding?

Medical research studies may draw faulty conclusions for a number of reasons. Perhaps there were too few participants to find meaningful differences. Maybe the dose of the treatment was too high or too low. But a major source of error in studies is called confounding.

It means an unexpected or external factor — not the one actually being examined — has led to the observed results. For example, let’s say two groups are compared for the risk of heart attack and the group with the higher risk has a less healthy diet. One might conclude that dietary choices led to poorer heart health. But what if those with the unhealthy diet also smoked far more than the healthy eaters? The smoking could be the real culprit. It is a confounder that must be accounted for if the research is to have credibility.

How could confounding affect the study results?

With this new study of tramadol, confounding is a real concern. For example, for a person who has both kidney disease and arthritis, doctors may prescribe tramadol rather than naproxen because the latter may worsen kidney disease. Yet kidney disease could increase the risk of other health problems, including a higher rate of death, which could then be attributed to the tramadol. In other words, the very reason your doctor chose tramadol could make this medication appear riskier than it really is.

The authors of the study acknowledge this possibility and took measures to limit it. In fact, many studies try to avoid these sorts of errors, but they are impossible to avoid completely.

The bottom line

If you take tramadol, talk to your doctor about this study. While the higher rates of death among tramadol users is worrisome, it’s not clear that tramadol is the actual culprit. We’ll need more research to confirm — or refute — the findings. If tramadol does increase the risk of death, we want to understand why and what to do about it (for example, is it an easily avoidable risk, such as an interaction with other medications?). Further research can also help educate doctors and patients about all of the potential risks of tramadol treatment.

Follow me on Twitter @RobShmerling

Comments:

  1. Becky Zachary

    I’ve been taking Ultram/Tramadol for years to assist in getting some pain relief. At one time, i was on very high dosages, then i couldn’t see that it was even helping me; so, i got off completely, cold turkey! I NEVER had any symptoms or side effects from taking this drug? I am just shocked to hear all the horror stories! After being off of the medicine, the doctor put me back on it but at a lower dose to take in conjuction with my other pain medicine to aid in controlling severe pain that i suffer from, and again,……..I’ve NEVER had any side effects or symptoms from taking this medication? Taking this med is like drinking water to me! I can’t say that it helps me any or I can’t say that it hurts me either? But my doctor is convinced that it does help! Thank goodness he doesn’t have to live with the pain I’m living with or he might have to agree with me!
    I am very concerned about all of these personal testimonies of people having had terrible symtoms & side effects from taking this med! Fortunately for me, i have not been affected in any way, good or bad!

    • Susan

      I have been taking tramadol since my microdisectomy on June 18. I am one of the few that got no relief from surgery from my nerve pain. I definitely notice when it is time for my next dose because the pain intensifies. I was doing some research on it and discovered it is addictive. I don’t quite understand what people would abuse it for. I am on a script of 50 mg 4 times a day as needed. I get no “high” whatsoever. Like you it is like drinking water in that i don’t notice any particular feeling from it. Just the pain subsides measurably for a few hours. I don’t want to take something addictive but I really can’t work at all without pain relief.

  2. Luke Powell

    I have had multiple surgeries for Dupuytren’s, and I love Tramidol. It cuts the pain without petting me on Mars. You need to drink a lot of water, and having to get up often at night is a hassle. You do have to slowly go off it though.

  3. Mark Basich

    I was prescribed Tramadol for severe back pain a couple of years ago. I was unable to sleep due to the pain, which is really a horrible thing! The Tramadol worked beautifully for me. I felt no pain, and my mood seemed slightly elevated. I certainly wasn’t high, just felt mildly better. It was great. then, I decided to stop, and went cold turkey. That was a mistake. I could not sleep, and was horribly depressed. The electrical outlets looked like “The Scream” by Edvard Munch. I cried at silly television dramas; tears streamed down my face. I felt a cold, deep sense of dread. It was awful. But, once it dawned on me why it was happening, I was able to handle it OK. Don’t go cold turkey!

    • C Heffner

      I take it for back and neck pain. It fogs me up sometimes, especially if I take muscle relaxers too, so sometimes I quit for a while. I went through very similar withdrawal symptoms too, but it seemed to ease up after three nights of no sleep and all that. Back in the day when my friends and I did certain hallucinogens, we’d call the comedown ‘the existential dreads’, and your comments reminded me of it. By the fourth night I was able to get some decent sleep. I’ll still stop taking it for short periods (then the pain gets too bad again), and I know I’m in for three sleepless nights and some moodiness, and I plan accordingly. CBD seems to help ease it some, btw, in case others read this.

  4. david secor

    What was the % of people who died taking none of these? I suggest this is not worth reading.

  5. Joie

    I had dental surgery a few years back (BIG owie), and the dentist asked if I wanted to try Tramadol gave me a prescription for Tramadol because it was not a narcotic. (Previously I would use 1/2 to1 Vicodin 10/325, which worked.) Well, of course I wanted to try it. Alas, it didn’t work as well as half a Vicodin did.

    • Jan

      I have been on tramadol since before it was deemed a controlled substance. I had a failed spinal fusion in 2008 and have had continuous pain from both that and osteoarthritis. Several years ago I had shingles down my right leg and developed a neuropathy from that. I am an avid hiker and would not be able to do the things I do without the nerve relief I get from tramadol, taken responsibly twice a day. It also assists in controlling irritable bowel syndrome, which I developed after being treated with Carac for skin lesions. I do not understand changing this to a controlled substance as I do not get anything but consistent nerve pain relief on a small dose. I get no high whatsoever. No ill side effects. I really think this is an overreaction to the opioid abuse by some which is causing undue stress on prescribing physicians and responsible pain patients. I am a retired RN and worked 35 years in critical care, a very physical job, thus the spinal fusion. I take my medication responsibly for a good quality of life and to be able to continue to hike, which keeps me healthy!

  6. DOYLE Wayne Hill

    I think that if the drug works for you then go for it but,,,,,,,,,,,,,,, those of us that it doesn’t do anything for you or myself it’s all about finding out everything you can about this drug and All it’s bad things it can do to help you and not hurt you worse or possibly kill you.D

  7. SS FL

    Thanks the truth hurts literally

  8. Barbara Thurman

    There are risks from any medication a person takes, always the possibility of side effects. Even OTC cold medicines have caused strokes. Need to always know risks and benefits of all medication you take. Not working well trying to make all pain medication evil, just isn’t true for millions provides some quality of life. majority of addiction started long before Doctor prescribed pain medication. If you really question addict has abused other illegal substances in past.

  9. Margie Bass

    For true chronic or intractable pain patients we would do as well as if we ate the buttons off our shirts.

  10. Vivian Leduc

    Thank you for the information 😊
    I’ve been on Tramadol for 6 years and it works for me. The other hard drugs upset my body.
    Went to Cardiac Specialist and was reassured medication has done no harm at this point.

    My neuropathy is idiopathic due to a spinal injury.

    My Spinal Cord stimulator helps, but I will need medication also.

    Tramadol is perfect for me. I’m 73 years old.

  11. Carla Mason

    I was prescribed tramadol as an alternative to opiates, for ongoing pain. I took them as prescribed, and developed a tolerance. The dosage was increased, and a year later, I’m addicted. The withdrawals were worse than those of opiates and took longer. They really didn’t do sufficient research on this drug. This was supposed to be the miracle drug for pain with no chance of dependency. What happened?

    • Robert Closson

      This worked for me. Eliminate 50 mg every week , I had very little discomfort and I am now on 300 mg. I feel great. I hope this helps. I definitely do not feel addicted anymore.

  12. Paula Ogle

    I was prescribed Tramadol after I injured my back. I gained weight, had severe joint and body pain. My heart would race. I got so bad I couldn’t take care of myself. My doc wouldn’t listen to me ,when I told him I was worse. If not for a family member telling me to stop the tramadol I believe I would have died….

  13. Aubrey Buxton

    I have taken Tramadol since it first hit the market and was called ultram. I hv osreoarthritis and fibromyalgia and I suffer, even taking Tramadol and Celebrex. This drug causes me to sweat. That’s it. I believe in quality of life, not quantity. I’m 70 yrs old and drug dealers hv better access to pain meds. I wd love something stronger but, nope, cant get it. It is ridiculous. I cant hv pain meds that work better, bc the Gov is watching out for me. I’m freaking 70 yrs old and wd love to hv less pain. Its ridiculous

    • Robert Closson

      Because of the new regulations people have not been getting the relief they need. In desperation they may turn to street drugs. My very reputable pain doctor told me he knew of suicides because patients could not suffer anymore with the limited doses they received.

      To the DEA, please do not cut down people in extreme pain. Please consider other options.

  14. Darlene Redden

    Tramadol is not safe. Unfortunately in my rural Kansas area, there is a high incidence of narcotic abuse so if you need pain medications the doctors go straight for tramadol. My husband has severe damage to his spine due to injury, and occasionally he needs pain medication. We keep telling the doctors he is allergic to tramadol, and they act like they’ve never heard that before. Some of his reactions to tramadol are vertigo, nausea, and fever. Doctors need a better education on the side effects of tramadol.

    • Bonnie

      As with most medications different people respond differently. If there is a bad reaction common sense dictates that it’s not the right drug for the individual. Those of us for whom tramadol works should be allowed to have it when it means the difference in having a life worth living versus not. I was on it for 16 years and was taken off cold turkey by the Mayo Clinic even though it goes against their protocol. Never saw that coming and it was a very traumatic and cruel experience for me. I’m in a great deal of pain all the time now and I cry daily because of it. I’ve developed anxiety about pain in general and about sleeping as I never get enough because of the pain. My life is not so great and it’s very wearing on me.

  15. Carol P Zengerle

    I took tramadol 3x a day for several years. Didn’t seem to help at all. Then the dr upped the dose to 8 pills a day. While I never took them all, I started having frequent seizures. I was told to stop taking it immediately. No more seizures, but I’m on a great med, Keppra XR.

  16. Sarah beach

    My son takes tramadol I was just wondering about it’s safety. He takes it as prescribed.

  17. Walkthewalk

    Having taken Tramadol for severe arthritis for years, imagine my dismay when Florida approved draconian laws regulating opiates, and included Tramadol.

    Sadly, my rheumatologist took the easy way out, rather than dealing with the new, stricter requirements, and stopped writing pain med scripts, including for Tramadol and including for me. Patients were expected to go “cold turkey”, or find another provider to write their script.

    My chiropractor intervened on my behalf and sent a letter to this doctor, advising him that he was putting me at great risk by this sudden and unprovoked change. Magically, my script was retored, but my faith in my provider and his lack of courage or concern was shattered.

    The FDA has recently, albeit quite too late for some, spoken out against this practice. In fairness, the overzealous bless of the Dea against innocent doctors is the real underlying problem.

    Back to Tramadol. It’s a decent pain reliever and even improves mood, too. Few doctors ealize it can also be used to help patients withdraw from morphine and other opiates, but a quick Google search will confirm this.

    Even if studies do show that Tramadol has a statistically higher death rate, it will merely allow it to join the ranks with Advil, Celebrex, Aleve, meloxicam and diclofenac.

    What scientists forget in this process is the pain scale and patient’s quality of life. Put differently, would you rather take Tramadol 3 times a day and risk a shorter lifespan, or sit in bed with a heating pad in misery and live to be 95?

  18. tractari-bv.ro

    Well… i think it would be wise to stop using it at least until further investigations showing clearly that benefits are greater than risks.

  19. Rae Harvey

    The biggest problem with Tramadol is that doctors tell patients that it is non-addictive, and that is a lie. Tramadol is a nightmare to come off of, as is evident by the THOUSANDS of internet postings asking for help with withdrawal.

    It is also dangerous to stop taking it suddenly…another thing patients aren’t warned about.

    We need to get serious about studying things like CBD and Kratom for pain management. And we need to acknowledge that our hysteria over marijuana became a huge underlying cause of the opioid crisis we now face.

    We must not let the pharmaceutical companies continue victimizing us for profit.

  20. Catherine Sanborn

    I am a retired registered nurse. For me Tramadol is very beneficial. I have in fact been taking it for at least two years. It relives my pain with one side effect. I metabolize drugs very fast and feel it quickly if I miss a dose. There have been no increase in dosage and no withdrawal. I am comfortable with it being a non opiate. I revisit the doctor every three months to maintain this therapy, as well as a counselor to review my mental health. If anyone was going to have poor side effects it would be me. I am extremely sensitive to all drugs and always in the group that has unanticipated reactions.

  21. Larry Adams Jr

    I was prescribed tramadol from the time it came out, until February of 2019.
    My Rheumatologist retired, and a new Doctor came in at the beginning of the “Doctor prescribed opiate scare”, as it began.
    My meds were cut off with no communication, and I went through the most intensely painful, horrifying, 2 weeks of my life..
    The muscle spasms, and inability to sleep, withdrawal symptoms lasted at least a month.
    Tramadol acts on the, Anti-Depressant, receptors of the brain as well as the opiate receptors.
    So you get a double withdrawl.
    If you are prescribed this medication, my advice is to think it through carefully.

  22. Tere

    I have asthma and tramodol affects it bad ! I I feel like I almost died

  23. Kempf

    Use this for your research I have taken it since 2006 never had a problem for years now I was giving two week refill to decide to take shots digging around in my spine I was born 12-25-58 kinda old for the spine digging

    • Kim

      The first nerve blocks will hurt due to it all being mental. The rest are a piece of cake. Your Dr can do them in a surgery center but that can be costly. I’ve had them done going on 17 yrs, doesn’t bother me at all. The numbing shot will be worst for you at first. Just place yourself else where, no talking and try to hold your breath as much as possible. Think of your favorite song/ tune also. Be over click of your fingers. Drs are super fast now. ☺️

  24. Kempf

    I have taken tramadol since2006 I never had a problem I tried them all 50mg works for my back and neck I went to a new doc he demanded I get shots and if they don’t work more shots no prescriptions

  25. Rand Bruso

    Tramadol can cause unpleasant side effects when taken with some SSRIs. Serotonin syndrome is associated with this combination of drugs.

  26. Frances

    I have been taking CBD oil for osteoarthritis for 6 weeks and it helps lessen the pain. However, I’ve also been experiencing more memory loss that usual and understand that this is a common side effect of CBD oil. If I apply the oil directly on the skin, will this also produce memory loss?

  27. Andrew J Savoie

    Seems a confounding study is just that and probably not worth publishing in an era of opioid hysteria. Because of CDC recommendations that were “misinterpreted” people who were dependent on medication to function were cut off. There is an alarming rate of suicides among the people who have no medicine to treat their chronic pain. Will those suicides be lumped into the opiate deaths? Tramadol is not an opiate just like aspirin is not warfarin. Because a couple of people in a room decided otherwise people are actually dying because they no longer want to live in pain. Why not study those people?

    • Ann Whittaker

      Exactly! I believe it is a real problem. I can honestly say the thought has crossed my mind if they start denying pain meds for me. It’s a very sad situation, very sad. Sometimes people show more humanity to animals than people. Don’t get me wrong-love animals.

  28. Lucy baysden

    I have arthritis and fibromyalgia. 25 years ago my doctor put me on tramadol. After being on this medication just a few days, I lost conciousness, fell and had a subdural hematoma. It took me years to adjust. I still have problems with my short term memory. I am now 65 years old.

  29. N. Campbell

    I have had Dr’s prescribe Tramadol on multiple occasions for back pain/carpal tunnel. Each time I experienced horrible side effects. Headache, nausea, stomach pain, & the last time was a year ago. I took one & ended up with my throat swelling, feeling hot/flush & red face & neck. I was miserable. Broke out into hives on my chest,
    This medication gave me far worse side effects than most other narcotic pain meds I have been treated with. I refuse to take it again. Glad more studies are coming out about this drug & its safety.

    • Dr. Fulford

      N. Campbell:

      Those aren’t side effects you are describing – those are allergic reactions. Throat swelling can be potentially life-threatening without medical intervention.

  30. Bobby E Sadler

    Tramadol, did nothing for me. It’s like taking aspirin. What’s the big deal?

  31. Connie Talley

    I was given this medication and it effected my eyes and felt like seeing shadows …headaches more then usual ..higher blood pressure …whether anyone like or regardless of age over 65 people who have been responsible are being treated to abuse by some doctors medical staff ..because you have reak.pain and those horrible pain pills keep you on your feet you insist to give medication that can hurt …re…darvocet my dad ended up almost unable to live a normal life

  32. Pamela Chester

    I am 75. I have Barretts Disease of the esophagus and osteoarthritis. (Bones crumbled during 4th knee surgery, I live with a ripped rotation cuff, BC surgeries and radiation). I do take 2 – 50 MG in afternoon when body just screams for help. It does not cure or bring total pain relief but it helps me to continue doing chores and participating in outings. Other rx ‘mess with my head’ but, Tramadol does not. I would dearly love to take aspirin but I am not allowed. I also use OTC Salonpas pain patches. I am quite thankful for the pain management offered by my pain doctor; I have appointments every 3 months for consulting and new rx. It is also reasonably priced.

Commenting has been closed for this post.