Tramadol - Top 8 Things You Need to Know

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Oct 22, 2024.

Generic Name: tramadol (TRAM a dol)
Brand Names: ConZip, Qdolo

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 a synthetic opioid (narcotic). It's opioid activity is due to binding to mu-opioid receptors. 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. Other opioids include drugs you may be more familiar with, like oxycodone or codeine. 

Some of the most important things to know about tramadol include:

• 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.
• Tramadol can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Dosing is individual for each patient and the lowest effective dose for the shortest duration should be used. Do not use more than one tramadol product at a time. Do not change your dose or stop treatment without talking to your healthcare provider.
• This medicine can slow breathing and may be fatal. Do not share or give this medicine with anyone as they could die from taking it.
• Keep it in a secure spot away from children, teens, visitors and pets. Tell your healthcare provider if you live in a household where there are small children or someone who has abused street or prescription drugs. Selling or giving away tramadol hydrochloride tablets is against the law.
• The safety and effectiveness of tramadol in children have not been established.

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, which may include 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.

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 7.7 million drug-related emergency department (ED) visits in the US occurred in 2022. Of these, 12.7% involved opioids, which included 20,443 ED visits due to tramadol.

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.
• Opioids including tramadol have made headlines in the last decade due to the tremendous problem of opioid addiction in the U.S.

Tramadol prescriptions in the U.S. may now only be refilled up to 5 times within a 6 month period after the date on which the prescription was written. After 5 refills or after 6 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

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. Certain people may be prone to more serious effects, too.

Do not take tramadol hydrochloride tablets if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• a tramadol allergy.
• taken a medicine used for depression, called a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days.

Before taking tramadol, tell your healthcare provider if you have a history of:

• head injury, seizures
• trouble urinating
• liver, kidney, or thyroid problems
• pancreas or gallbladder problems
• current or past abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

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 doctor for medical advice about side effects.

The most common side effects of tramadol:

• dizziness / vertigo
• nausea / vomiting
• constipation (can be more common in the elderly > 75 years)
• headache
• itching
• dry mouth
• sleepiness, 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 make you sleepy or impair your thinking or mental capacity, do not drive or perform any hazardous activities.

Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with tramadol may cause you to overdose and die.

Call 911 or get emergency help right away if you, or someone you care for, takes too much tramadol (overdose) or has 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

Serious or deadly breathing problems may be more likely to occur when you first start taking tramadol, when your dose is changed, or if you take too much (overdose). 

Talk to your doctor about having naloxone, a medicine for the emergency treatment of an opioid overdose, on hand. You can get it at your pharmacy without a prescription.

A person caring for you should call 911 (in the US) or get emergency medical help and administer naloxone (if available) if you have slow breathing with long pauses, blue-colored lips, or if they find it hard to wake you up. Trouble with breathing may be more serious and likely in older adults, people who are debilitated, and people who have wasting syndrome or chronic breathing disorders.

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 surgery to remove the tonsils and/or adenoids (tonsillectomy and / or adenoidectomy).
• Tramadol use should be avoided in children 12 to 18 years of age who have risk factors that may increase their risk of slowed or stopped breathing with tramadol.
  
  • Risk factors may include: risk of slowed breathing, 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.

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, trouble eliminating the drug from the body and constipation.
• Respiratory depression (slowed or stopped breathing) 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 suspect 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 (such as metabolism via the CYP450 enzyme system) 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.

Taking tramadol hydrochloride tablets with certain other medicines can cause serious side effects that could lead to death.

For example:

• The use of tramadol with other opioids (examples: hydrocodone or oxycodone), 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, ritonavir, rifampin, St. John's Wort, phenytoin or carbamazepine may change the blood levels of tramadol. This could causes serious or deadly side effects or change how well tramadol works for you. There are many other drugs that may do this, too, so 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)

A person's genetics can affect their response to tramadol, including their risk of side effects. 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.

• Learn more: How do genetics affect tramadol?

Serious side effects including seizures and serotonin syndrome may also occur due to certain drug interactions.

• Serotonin syndrome symptoms may include agitation, hallucinations, coma, fast heart rate, blood pressure changes, high body temperature, incoordination, rigidity, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later. Serotonin syndrome can also occur with use of tramadol alone.
• Tramadol should never be used with an MAOI inhibitor (for example: phenelzine, tranylcypromine, linezolid) or within 14 days of taking an MAOI due to increased serotonin syndrome risk.
• Taking tramadol with drugs that already cause a risk of a seizure may increase that risk. 

Patients should always have a drug interaction review completed each time they start or stop a medication, including prescription drugs, herbals, over-the-counter (OTC) medicines, and supplements like vitamins.

This is not a full list of possible drug interactions with tramadol. 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.

Naloxone

• Talk to your healthcare provider about naloxone (brand examples: Narcan, Kloxxado, Rezenopy, Zimhi), a medicine you can keep on hand or at your house for emergency treatment of an overdose. It is important to have naloxone on hand if you or anyone in your home takes any opioid medicine.
• Narcan Nasal Spray and Rivive are naloxone nasal sprays available at the pharmacy without a prescription. Ask your pharmacist or doctor for availability and information. 

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 or DEA registered collector. Ask your pharmacist about the availability of these programs or how 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 may help to save you some money. Ask your physician to only prescribe generic drugs whenever possible if you 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 as a generic option.

Products that contain tramadol include:

• Conzip (tramadol ER oral capsule)
• Qdolo (tramadol oral solution)
• tramadol and acetaminophen oral tablet - available generically
• tramadol oral tablet - available generically; in immediate-release and extended-release forms. (Note: The Ultram and Ultram ER brands have been discontinued by the manufacturer).

Learn more about generic drugs: Facts About Generic Drugs

7. Tramadol use in special populations

Don't forget - selling or giving away tramadol is against the law. 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.

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).

Related: Review tramadol dosing (in more detail)

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 (neonatal opioid withdrawal syndrome) 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. Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of tramadol hydrochloride tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended; it may harm your baby. Tell your healthcare provider if you are breastfeeding before you start taking tramadol.

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 experience pain or who are in need of addiction support.

Joining one or more support groups is a great way to discover others with similar medical conditions, to keep up with related 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 1800 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.

This is not all the information you need to know about tramadol for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

Further information

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