Generic Name: tramadol (TRAM a dol)
Brand Names: ConZip, Ultram
Maybe you’ve heard that tramadol is a “safer” pain medication. But is that really true?
The facts: tramadol is a centrally-acting, oral analgesic (pain drug) that contains an opioid (narcotic). Other opioids include drugs you may be more familiar with, like oxycodone or codeine. Opioids have made headlines over the past few years due to the tremendous problem of opioid addiction in the U.S.
Tramadol is approved for the treatment of pain in adults that is severe enough to require an opioid analgesic and for which other treatments do not work or are not tolerated. In addition to acting at the opioid pain receptor, tramadol also inhibits uptake of two neurotransmitters, norepinephrine and serotonin, which may add to its pain-relief effects, although the exact mechanism isn’t exactly known.
In 1995, tramadol was originally approved by the U.S. Food and Drug Administration (FDA) as a non-controlled analgesic. However, since 1995, changes to the controlled substance status of tramadol have been made due to reports of drug abuse, misuse and criminal diversion (shifting of any legally prescribed controlled substance from the patient to another person for any illicit use, such as abuse or sale on the streets).
1. Tramadol is now a controlled substance in all 50 U.S. states
The U.S. Drug Enforcement Administration (DEA) announced that tramadol was placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014.
- The new scheduling applies to all forms of tramadol.
- The rescheduling of tramadol came at a time of growing concern related to abuse, misuse, addiction and overdose of opioid analgesics.
- Previously tramadol was a controlled substance in only a few states.
Tramadol prescriptions in the U.S. may now only be refilled up to five times within a six month period after the date on which the prescription was written. After five refills or after six months, whichever occurs first, a new prescription is required. This rule applies to all controlled substances in schedule III and IV.
Ask your pharmacist how to properly dispose of tramadol or any opioid that you are prescribed.
Learn More: How to Safely Dispose of Your Old Medications
2. Tramadol is associated with a wide array of side effects
In many people, tramadol is well-tolerated when used for pain, but tramadol can also cause some common and serious side effects. In fact, the Drug Abuse Warning Network (DAWN) has reported that over 50,000 emergency department visits were related to tramadol use, and over half of these visits were related to side effects of the drug.
It is important to review with your doctor the side effects that may occur with tramadol before starting treatment. Side effects with tramadol may worsen with higher doses or with drug interactions. Starting tramadol slowly and at a lower dose may help to lessen side effects at the beginning of treatment. Call your healthcare provider if you have any of these side effects that are severe or concerning to you.
Common side effects may include:
- constipation (can be more common in the elderly > 75 years)
- nervousness, anxiety, agitation
- stomach pain
Serious side effects, some of which are rare, may include:
- addiction, abuse, and misuse, which may lead to overdose and death, even at normal doses
- depressed breathing (respiratory depression), which may be life-threatening or fatal
- ultra-rapid metabolism (break down of the drug in the body for elimination) of tramadol and other risk factors for life-threatening respiratory depression in children (some cases occurred after tonsillectomy or removal of adenoids).
- neonatal opioid withdrawal syndrome
- effects due to drug interactions with benzodiazepines or other sedative-type (CNS depressant) drugs
- serotonin syndrome
- suicide or attempted suicide
- adrenal insufficiency
- severe hypotension (low blood pressure)
- gastrointestinal adverse reactions
- androgen deficiency
- abnormal heart rhythms
- severe hypersensitivity (allergic) reactions
Breathing changes like slowed or stopped breathing can occur at any time with tramadol, but the risk is greatest when treatment is first started (within the first 24 to 72 hours) or when there is a change in your dose.
You should not use tramadol if have severe asthma or breathing or lung problems, a bowel blockage or narrowing, or an allergy to tramadol. Do not use tramadol if you have taken a monoamine oxidase inhibitor (MAOI), a type of drug for depression, in the last 14 days.
Seizures have occurred in patients taking recommended doses but are more likely at high doses associated with abuse of tramadol.
Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, or tremors may occur. Consult with your doctor for a slow, tapering dose schedule if you are stopping tramadol treatment.
Tramadol should not be used during breastfeeding; tell your doctor if you are pregnant or plan to become pregnant.
Warnings: Tramadol Use in Children
- Life-threatening respiratory depression (difficult, slowed breathing) and death have occurred in children who received tramadol. Accidental ingestion of tramadol in children can be fatal.
- Tramadol (brand names include Ultram, ConZip) should NOT be used in children younger than 12 years of age.
- It’s especially important that tramadol NOT be used in children up to age 18 years of age after tonsillectomy and/or adenoidectomy surgical procedures (removal of tonsils and/or adenoids).
- Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol. Risk factors may include: respiratory depression after surgery, obstructive sleep apnea, obesity, severe lung disease, neuromuscular disease, and use of other medications at the same time as tramadol that also cause respiratory depression (slowed or stopped breathing).
Warnings: Tramadol Use in the Elderly
- The elderly may be especially prone to side effects with tramadol due to lowered liver or kidney function and reduced metabolism or excretion.
- Patients older than 75 years appear to be more prone to gastrointestinal side effects like constipation (30%) than patients less than 65 years (17%).
3. Dangerous metabolism, drug interactions with tramadol
You probably already suspected that tramadol has drug interactions, but you may not know the extent and seriousness that some of these drug interactions can cause. Also, the way that the drug is broken down and excreted from the body (metabolism) is complicated and sometimes unpredictable, especially in children.
If you are known to be an “ultra-rapid metabolizer” you should not use tramadol. This means that you create the active M1 metabolite from tramadol more quickly than others, and are at risk for dangerous or even fatal respiratory depression or overdose.
Tramadol is known to interact with drugs that are affected by cytochrome P450 (CYP450) enzymes. Specifically it can interact with drugs that affect the 3A4 and 2D6 enzymes. There are hundreds of these drugs, and it’s important you ask your pharmacist to check for drug interactions.
- Use of tramadol with these agents can decrease OR increase the metabolism (break down and excretion) of tramadol or M1 in your body, leading to abnormally high or low blood levels of the drug.
- When blood levels are too high, symptoms of opioid toxicity and worsened side effects can occur.
- When blood levels are too low, opioid withdrawal and lack of pain control can occur.
- Drugs like ketoconazole, erythromycin, rifampin, St. John’s Wort, or carbamazepine may alter the blood levels of tramadol, but there are many others.
Serious side effects including seizures and serotonin syndrome may also occur due to drug interactions. Examples of drug classes where this might occur include the serotonin reuptake inhibitors (SSRIs, SNRIs), TCAs and MAO inhibitors (like phenelzine or linezolid) — all types of antidepressants. In fact, tramadol should never be used with an MAOI inhibitor or within 14 days of taking an MAOI. Taking tramadol with drugs that already have a seizure risk may worsen that risk.
Patients receiving serotonergic drugs (for example, the migraine class called “triptans”) may also be at a higher risk for serotonin syndrome.
- Brand names of triptans include: Imitrex, Zomig, Maxalt, and others.
- However, serotonin syndrome and elevated seizure risk can occur with many other medications, too.
- A drug review by your pharmacist can predict if you may be at risk for these dangerous effects.
The use of tramadol with benzodiazepines (or any other sedative, hypnotic or tranquilizer), anti-anxiety medication, muscle relaxant, anesthetic, antipsychotic, alcohol or other narcotic medications (including illegal drugs) can lead to extreme sedation, slowed or stopped breathing, coma and death.
- Tramadol should not be combined with any CNS depressant-type drug unless under the direction of your doctor.
- Do not drink alcohol or use illegal drugs while taking tramadol.
- You should avoid driving, operating machinery or other activities that require mental alertness until the effects of the drug are known and you are sure you can safely drive. If the drug continues to impair your physical or mental ability, do not drive.
Patients should always have a drug interaction review completed each time they start a new medication, or even stop a medication, and that includes prescription drugs, herbals, over-the-counter (OTC) medicines, and supplements like vitamins. Your pharmacist can advise you on possible tramadol drug interactions, so be sure to ask.
4. Tramadol can be habit-forming
Tramadol is structurally related to the opioids like codeine and morphine and can lead to psychological and physical dependence, addiction, and withdrawal. People with a history of a drug-seeking behavior may be at greater risk of addiction, but illicit actions to obtain the drug can occur in people without a prior addiction, as well. Takes steps to secure your tramadol in a safe place at home to prevent theft or accidental overdose.
Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, sweating, difficulty in sleep, shivering, pain, tremors, or rarely, hallucinations may occur.
Consult with your doctor before discontinuing tramadol treatment; do NOT discontinue treatment on your own. Withdrawal symptoms may be relieved by re-initiation of opioid therapy followed by a slow, dose reduction combined with symptomatic support, as directed by your doctor.
5. What is an Opioid Analgesic REMS?
Some medications have an inherent risk that require a restricted program known as a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use. All opioid drugs like tramadol have an Opioid Analgesic REMS program in place as mandated by the FDA.
- A REMS is a medication safety program for certain medications with serious safety concerns or dangerous side effects to help ensure the benefits of the medication outweigh its risks. The FDA may require these and they are developed by the drug manufacturer.
- There are typically many steps to complete for a REMS, and can involve education and certification of healthcare providers, patients, pharmacies, and drug wholesalers.
- Creation of a Medication Guide that is updated with important patient information is part of the Opioid Analgesic REMS. The patient receives this each time they fill their opioid prescription and should review for changes.
6. Tramadol is available in both immediate-release and extended-release formulations.
Both the immediate-release and extended-release formulation of tramadol are available generically and can possibly save you hundreds of dollars on your prescription.
If you prefer generic medications due to cost-savings, ask your physician to only write for generic drugs whenever possible. If you cannot afford your medication, do not walk away from the pharmacy. Ask your doctor or pharmacist for more affordable alternatives.
The extended-release form of tramadol is for around-the-clock treatment of pain and not for use on an as-needed basis. Tramadol extended-release tablets must be taken whole, and not split, chewed or crushed.
- Combining tramadol with acetaminophen (Tylenol) may further help with pain and allow lower doses of tramadol to be used.
- However, Ultracet is not approved for use for more than 5 days.
- Also, be careful not to combine Ultracet with extra acetaminophen (Tylenol), as too much acetaminophen is toxic for your liver.
Learn more about generic drugs in “Facts About Generic Drugs”.
7. Dose adjustments are needed in the elderly, and in those with kidney or liver problems.
Here’s another good reason not to share your tramadol with others: the dose you are prescribed may not be the right dose for someone else, and could lead to serious consequences like slowed or stopped breathing, coma, or even death.
As with many medications, if you are young, elderly, or have kidney or liver disease dose adjustmentsare often required.
- The dosing interval (how often you take the drug) may need to be adjusted, the actual dose of the drug may need to be reduced, and you may have a maximum daily dose you should not exceed.
- Talk to your doctor about the need for adjusted doses with any medication, including tramadol.
- Do not exceed the prescribed dose or dosing interval prescribed by your doctor.
Patients older than 65 years of age
- Doses should usually start at the low end of the dosing range and can be titrated upwards slowly based on tolerance and effectiveness.
Patients older than 75 years of age
- Maximum dose of regular-release tramadol oral tablets: 300 mg per day (in divided doses).
Kidney Disease and Liver Disease
Over 30% of tramadol is excreted by the kidneys as the unchanged molecule, which means it could lead to toxic blood levels in patients with kidney disease.
- Tramadol is metabolized through the liver, so a patient with kidney or liver disease may require a change in dose, different dose interval, or maximum amount of drug taken each day.
- Some patients with severe kidney or liver impairment may not be candidates for tramadol treatment at all.
- Providers should consider monitoring renal function (such as creatinine clearance) with tramadol treatment, especially in the elderly, because this drug is substantially excreted by the kidney.
8. There are ways to engage with other patients using tramadol.
Support groups may be helpful for patients who take tramadol, who use medications for pain relief, who are in need of addiction support, and for many other needs.
Joining one or more support groups is a great way to discover others taking related medications with similar medical conditions, keep up with the news, and share your own experience.
- Tramadol Support Group
- Ultram Support Group
- Fibromylagia Support Group
- Pain Support Group
- Addiction Support Group
- Opiate Dependence
- Depression Support Group
There are over 1300 reviews for tramadol from patients who use this drug for general pain, back pain, tooth pain and other various conditions (some of which may be off-label use, meaning the drug is not approved by the FDA for that particular use).
Remember, this information is NOT intended to endorse tramadol or recommend therapy. While these reviews may or may not be helpful to you, they are NOT a substitute for the expertise, skill, knowledge and judgement of your individual healthcare provider.
- Ultram product label. Janssen Pharmaceuticals, Inc. Revised 9/2018. Accessed Dec. 11, 2018 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf
- Drug Enforcement Administration. Office of Diversion Control. Drug & Chemical Evaluation Section. Tramadol. (Trade Names: Ultram, Ultracet).
- Bush DM. Emergency Department Visits for Adverse Reactions Involving the Pain Medication Tramadol. 2015 May 14. In: The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013. Accessed Dec. 11, 2018 at https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
- Drug Enforcement Administration. Office of Diversion Control. Drug and Chemical Evaluation Section. Tramadol.
(Trade Names: Ultram, Ultracet). Accessed Feb. 27, 2018.
- Sansone RA, Sansone LA. Tramadol: Seizures, Serotonin Syndrome, and Coadministered Antidepressants. Psychiatry (Edgmont). 2009;6:17-21. Accessed Feb. 27, 2018 at https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
- Tramadol Product Label. Drugs.com. Accessed Dec. 12, 2018 at https://www.drugs.com/tramadol.html
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.