Tramadol - Top 8 Things You Need to Know
Generic Name: tramadol (TRAM a dol)
Brand Names: ConZip, Qdolo, Ultram
Maybe you've heard that tramadol is a "safer" pain medication. But is that really true? Is tramadol a narcotic?
The facts: tramadol is classified as a centrally-acting, oral analgesic (pain drug) that contains an opioid (narcotic). So yes, tramadol is a 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. Dosing is individual for each patient. The lowest effective dose for the shortest duration should be used. Do not use more than one tramadol product at a time or exceed the dose prescribed by your doctor.
The safety and effectiveness of tramadol in children have not been established.
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 classification 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.
2. Tramadol is associated with a wide variety 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.
Learn more: List of tramadol side effects
Tramadol has a long list of serious and potentially deadly side effects. It is important to discuss these side effects with your doctor before you start treatment as they can get worse with higher doses or with some drug interactions.
Your doctor may have you start this drug slowly and at a lower dose to help lessen side effects at the start of treatment. Follow your doctor's instruction exactly. Call your healthcare provider if you have any side effects that are severe or concerning to you.
The most common side effects (15% or more) may include:
- dizziness / vertigo
- nausea, vomiting
- constipation (can be more common in the elderly > 75 years)
- dry mouth
- somnolence, drowsiness
You should avoid driving, operating machinery or other activities that require mental alertness until you know how tramadol will affect you.
If the drug continues to impair your physical or mental ability, do not drive or perform potentially hazardous activities.
Call 911 or get emergency help right away if you have any of these serious side effects:
- trouble breathing, shortness of breath
- fast heartbeat
- chest pain
- swelling of your face tongue or throat
- extreme drowsiness
- you feel lightheaded or faint
- you get agitated or confused
- your body temperature gets higher than normal
- trouble walking, stiff muscles
Tramadol safety in children
It is not known if tramadol is safe or effective in children. Life-threatening respiratory depression (difficult, slowed breathing) and death have occurred in children who received tramadol. Accidental ingestion or exposure of tramadol in children, even one dose, can be fatal.
- Tramadol should NOT be used in children younger than 12 years of age (it is contraindicated).
- Tramadol should NOT be used in children younger than 18 years of age after tonsillectomy and / or adenoidectomy surgical procedures (removal of tonsils and/or adenoids).
- Tramadol use should be avoided in children 12 to 18 years of age who have other risk factors that may increase their risk of slowed or stopped breathing with tramadol.
- Risk factors may include: risk of slowed breathing after surgery, obstructive sleep apnea, obesity, severe lung disease, nerve / muscle disease, and use of other medications that can slow or stop breathing.
- Only your doctor can decide if it's safe to use tramadol in any child 12 to 18 years of age.
Tramadol safety in the elderly
- Patients 75 years of age and older should not take more than 300 mg per day of tramadol in divided doses. The elderly may be especially prone to side effects with tramadol due to reduced liver or kidney function and trouble eliminating the drug from the body.
- Respiratory depression is a chief risk of opioid use in older patients. Your doctor may decide to slowly increase or change your dose to monitor you for side effects.
- Patients older than 75 years appear to be more prone to stomach side effects like constipation (30%) than patients less than 65 years (17%). In studies, 10% of patients over 75 years stopped tramadol treatment due to constipation.
There are many other side effects and warnings with tramadol and this is not a complete list. Review a full list of tramadol warnings and side effects here and discuss with your doctor.
3. 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.
There can be many complex drug interactions with tramadol so it's important you ask your pharmacist or doctor to check for these drug interactions. Some drug interactions can lead to high or low blood levels of this drug that are not normal and can cause dangerous side effects, opioid withdrawal or a lack of pain control.
- The use of tramadol with other opioids, benzodiazepines (or any other sedative, hypnotic or tranquilizer), alcohol or drugs that may depress your central nervous system (including illegal or street drugs) can cause severe drowsiness, decreased awareness, serious breathing problems, coma and death.
- Do NOT drink alcohol or use abuse illicit drugs, street drugs or other opioids while taking tramadol. Do not use over-the-counter medicines that contain alcohol with tramadol as you may overdose and die.
- Drugs like ketoconazole, erythromycin, rifampin, St. John's Wort, or carbamazepine may alter the blood levels of tramadol, but there are many others. Tell your healthcare provider about all of the medicines you use, including prescription, over-the-counter (OTC), herbal or dietary supplements and even vitamins.
Review: Tramadol drug interactions (in more detail)
If you are known to be an "ultra-rapid metabolizer" you should not use tramadol. This means that you create a strong breakdown product from tramadol more quickly than others, and are at risk for dangerous or even fatal slowed breathing (respiratory depression) or overdose.
Serious side effects including seizures and serotonin syndrome may also occur due to certain drug interactions. 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 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 or doctor can advise you on possible tramadol drug interactions, so be sure to ask. Show them a complete list of all of your medicines.
4. Tramadol can be habit-forming
Tramadol is structurally related to the opioids like codeine and morphine and can increase your risk for misuse, abuse, addiction, overdose and death, even if you take the medicine exactly as prescribed by your doctor. Never share tramadol with anyone else, as they could die from taking it.
Talk to your healthcare provider about naloxone (brand example: Narcan, Zimhi), a medicine you can keep on hand or at your house for emergency treatment of an overdose. It is important to have Narcan on hand if you take any opioid medicine. Ask your pharmacist or doctor about getting naloxone to help reverse an overdose emergency.
If you use tramadol on a regular basis, do not abruptly stop taking it on your own without talking to your doctor first. Serious side effects (withdrawal symptoms) like nausea, diarrhea, anxiety, sweating, trouble sleeping, shivering, pain, tremors, or rarely, hallucinations may occur.
Keep your tramadol in a safe and out-of-sight place at home to prevent theft, accidental overdose or death. Keep out of the reach of children and pets. Dispose of unused tramadol in a Drug Take-Back Program. If one is not available, your pharmacist can tell you the best way to safely dispose of tramadol.
Learn More: How to Safely Dispose of Your Old Medications
5. What is a 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 required by the FDA.
- A REMS is a medication safety program used for certain medications with serious safety concerns. These programs help ensure the benefits of the medication outweigh its risks. The FDA may require a REMS program, and they are developed by the drug manufacturer.
- A REMS includes a Medication Guide that is updated with important patient information. You will receive this guide each time you fill your tramadol prescription and you should review it for important changes.
6. Is tramadol available generically?
Saving money at the pharmacy counter is always a good thing. Both the immediate-release and extended-release (ER) formulations of tramadol are available generically and can possibly save you hundreds of dollars on your prescription. Ask your physician to only prescribe generic drugs whenever possible if prefer these cost-savings.
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 / capsules must be swallowed whole and intact; do not split, break, chew, crush or dissolve the product.
There are also combination products of tramadol with other pain medicines like NSAIDS or acetaminophen. Not all products are available in the generic form.
Brand name products that contain tramadol include:
- Conzip (tramadol ER oral capsule)
- Qdolo (tramadol oral solution)
- Seglentis (tramadol and celecoxib oral tablet)
- Ultracet (tramadol and acetaminophen oral tablet) - also available generically
- Ultram (tramadol oral tablet) - also available generically; in immediate-release and extended-release forms. The Ultram ER brand name has been discontinued by the manufacturer.
Learn more about generic drugs: Facts About Generic Drugs.
7. Special populations
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. Special doses may be needed in the elderly, and in those with kidney or liver disease.
Related: Review tramadol dosing here (in detail).
As with many medications, if you are young, elderly, or have kidney or liver disease dose adjustments are often required. In patients older than 75 years of age the maximum dose of regular-release tramadol oral tablets: 300 mg per day (in divided doses).
Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. If you use tramadol while you are pregnant, your baby could become dependent on the drug (addicted). Possibly fatal withdrawal symptoms may occur in your baby after it is born, causing death. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Do not breastfeed while taking tramadol. This medicine can pass into your breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
Learn More: Tramadol Pregnancy and Breastfeeding Warnings
8. There are ways to engage with other patients using tramadol.
Your doctor should always be your first and final contact for advice on tramadol use. However, support groups may be helpful for patients who take tramadol, who use medications for pain relief, or who are in need of addiction support.
Joining one or more support groups is a great way to discover others taking related medications with similar medical conditions, keep up with the medical 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 like you who use this drug for general pain, back pain, fibromyalgia 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).
This information is NOT a complete overview of tramadol. It 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.
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Symptoms and treatments
Medicine.com guides (external)
- FDA. Ultram product label. Janssen Pharmaceuticals, Inc. Revised 9/2021. Accessed Feb 17, 2022 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s049lbl.pdf
- Conzip (tramadol extended-release) prescribing information. Sept. 2021. Vertical Pharmaceuticals, LLC Bridgewater, NJ. Accessed Feb. 17, 2022 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s023lbl.pdf
- US Food and Drug Administration (FDA). Drugs@FDA: FDA-Approved Drugs. Accessed Jan. 27, 2020 at https://www.accessdata.fda.gov/scripts/cder/daf/
- D.M. Bush. The CBHSQ Report: Emergency Department Visits for Adverse Reactions Involving the Pain Medication Tramadol. (2015). Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Rockville, MD. Accessed Feb. 17, 2022 at https://www.samhsa.gov/data/report/emergency-department-visits-adverse-reactions-involving-pain-medication-tramadol
- Drug Enforcement Administration. Office of Diversion Control. Drug and Chemical Evaluation Section. Tramadol. (Trade Names: Ultram, Ultracet). Accessed Feb. 17, 2022 at https://www.deadiversion.usdoj.gov/drug_chem_info/tramadol.pdf
- Sansone RA, Sansone LA. Tramadol: Seizures, Serotonin Syndrome, and Coadministered Antidepressants. Psychiatry (Edgmont). 2009;6:17-21. Accessed Feb. 17, 2022 at PMCID: PMC2714818
- Tramadol Product Label. Drugs.com. Accessed Feb. 17, 2022 at https://www.drugs.com/tramadol.html
- Qdolo (tramadol) [product information]. Sept. 2020. Athena Bioscience. Athens, GA. Accessed Feb. 17, 2022 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214044s001lbl.pdf
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.