Tramadol, an opioid used for pain, has a long list of serious (bad) side effects. Some of the most serious side effects with tramadol use are outlined in its Boxed Warning. A Boxed Warning is the most stringent safety warning from the FDA. The Boxed Warning for tramadol outlines some of the serious side effects with tramadol, such as:
- possibly deadly breathing problems in both adults and children. Tramadol should NOT be used (is contraindicated) in children younger than 12 years of age. Tramadol should NOT be used in children younger than 18 years of age following a type of surgery to remove the tonsils and/or adenoids.
- serious, possibly fatal health risks, such as extreme sleepiness, slowed or stopped breathing (respiratory depression), coma and death may occur when tramadol is combined with other CNS depressants such as: alcohol, benzodiazepines, other opioids, sedatives, anti-anxiety medicines, and illicit street drugs, among others.
- 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)
- the risk of opioid (narcotic) misuse, abuse and addiction, and death, even if you take your dose as prescribed by your doctor
- accidental ingestion, overdose, death. Get emergency help (for example, call 911) right away if you take too much tramadol.
- withdrawal symptoms in newborns exposed to opioids like tramadol during pregnancy. These withdrawal symptoms may be life threatening if not recognized and treated. Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Tramadol use is not recommended while breastfeeding.
- dangerous, complex drug interactions due to enzyme alterations
- Severe allergy if you are allergic to tramadol or other opioids, or any other component of the medicine.
Only take the dose of tramadol that your doctor prescribes; DO NOT change your dose or how often you take it unless your doctor directs you to do this. Use the lowest dose possible for the shortest time needed. Call your doctor if the dose you are taking does not control your pain.
Get emergency medical help if you have:
- trouble breathing
- shortness of breath
- fast heartbeat
- chest pain
- swelling of your face, tongue, or throat
- extreme drowsiness
- light-headedness when changing positions
- feeling faint
- agitation
- high body temperature
- trouble walking
- stiff muscles
- mental changes such as confusion.
Do not take tramadol if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines
- an allergy to tramadol
- taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.
Before taking tramadol, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
If you experience any serious side effects, or have concerns about your treatment, contact your health care provider immediately. Tell your doctor if you have a history of drug abuse or addiction before tramadol is prescribed.
There are many other serious and common side effects associated with tramadol. See the full prescribing information, Medication Guide and details on the complete Boxed Warning. Discuss your risk for tramadol side effects with your doctor before your start treatment.
Are there other warnings or serious side effects with tramadol?
Yes, other serious effects that may occur with tramadol include:
- serotonin syndrome (a potentially life-threatening condition) - symptoms may include mental status changes (such as agitation, hallucinations, coma, delirium), a fast heart rate, dizziness, flushing, muscle tremor or rigidity and stomach symptoms (including nausea, vomiting, and diarrhea).
- seizures
- suicide or attempted suicide
- adrenal (hormone) insufficiency
- a higher risk of life-threatening breathing problems in those with: lung disease, sleep apnea, the elderly, the very ill or those in a debilitated state.
- severe hypotension (low blood pressure)
- risk in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness
- gastrointestinal (stomach, intestine) side effects
- abnormal heart rhythms
- severe hypersensitivity (allergic) reactions
Is tramadol safe for children?
Only a doctor can determine if tramadol is safe to use in a child.
- Tramadol should NOT be used (is contraindicated) in children younger than 12 years of age.
- Tramadol should NOT be used in children younger than 18 years of age following a type of surgery to remove the tonsils and/or adenoids.
- Tramadol should be avoided in adolescents 12 to 18 years of age who have other risk factors (obstructive sleep apnea, obesity, lung problems) that may increase their sensitivity to breathing problems while taking tramadol.
Life-threatening respiratory depression (slowed or stopped breathing) and death have occurred in children who received tramadol. Some of the reported cases followed surgery to remove the tonsils and/or adenoids. In at least one case, the child had evidence of quickly breaking down tramadol in their body due to an alteration in enzymes called CYP2D6.
Is tramadol bad for your liver or kidneys?
Side effects like increased liver enzymes, hepatitis and liver failure have been reported in people using tramadol, but it is not known if tramadol caused these side effects directly. How often these side effects may occur are not known.
In addition, if you already have kidney or liver disease, your dosage of tramadol may need to be adjusted. Tramadol is eliminated from your body by both the kidneys and liver, so you need good kidney and liver function to use this medicine.
Is tramadol an opioid like oxycodone?
Yes, tramadol is a strong prescription pain medicine that contains an opioid (narcotic). Other opioids include medicines like hydrocodone, oxycodone or morphine. Heroin, a federally illegal drug is also an opioid. Tramadol is used only when other pain treatments such as non-opioid medicines (for example, acetaminophen, ibuprofen) do not work or you cannot tolerate them.
Never give anyone else your tramadol as they could die from taking it. Selling or giving away tramadol is against the law. Tramadol is classified by the DEA as a C-IV controlled substance.
Do not drive or operate heavy machinery until you know how tramadol will affect you. Tramadol can make you sleepy, dizzy, or lightheaded. Do not drink alcohol or take other CNS depressants with tramadol. This can be deadly.
When you first start taking tramadol, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Store tramadol securely, out of sight and reach of children, and in an area others cannot get to, including visitors to the home. Accidental ingestion, especially in children, can be life-threatening or fatal due to respiratory depression.
Certain medicines have a higher safety risk that requires a Risk Evaluation and Mitigation Strategy (REMS), an FDA-mandated safety program. All opioid drugs like tramadol have an Opioid Analgesic REMS program in place.
When you receive your tramadol prescription, an updated Medication Guide that contains important patient information will be attached. It is part of the Opioid Analgesic REMS. Be sure to review it with each refill and look for any changes. If you have questions or concerns, ask your pharmacist or doctor.
Are there serious drug interactions with tramadol?
Yes, there are many serious drug interactions with tramadol. Tell your doctor and pharmacist about all of the medications you take, including prescription, over-the-counter medicines, herbal products and dietary supplements. Any time you start or stop a medication, have your doctor or pharmacist check for drug interactions.
Drug interactions with tramadol and an enzyme system in your body known as the cytochrome P450 enzyme system are complex. These interactions can occur with common medicines, such as some antidepressants, antipsychotics, St John's Wort, or
Tramadol should not be used with or within 14 days of using a drug class known as monoamine oxidase inhibitors (MAOIs).
Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol while you are taking tramadol. Using products containing alcohol during treatment with tramadol may cause you to overdose and die.
Taking tramadol with other opioid medicines, benzodiazepines (for example, Valium), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Learn More: Drug Interactions with Tramadol (in more detail)
What are the common side effects with tramadol?
More common side effects with tramadol may include:
- dizziness / vertigo
- nausea, vomiting
- constipation
- stomach pain, heartburn
- diarrhea
- headache
- dry mouth
- weakness (asthenia)
- decreased appetite
- itching
- sweating
- tiredness, somnolence, drowsiness, sleepiness
- nervousness, anxiety, agitation
Call your healthcare provider if you have any of these symptoms and they are severe.
Bottom Line
Tramadol can be associated with many bad (serious) side effects, including addiction, slowed or stopped breathing, overdose, and death. Talk to your doctor about tramadol side effects before you start taking it.
In addition, there are other serious warnings, drug interactions, side effects and warnings in children. Do not use tramadol in children younger than 12 years of age or children younger than 18 years of age following a type of surgery to remove the tonsils and/or adenoids. Tramadol may need to be avoided in adolescents 12 to 18 years of age who have other risk factors.
This is not all the information you need to know about tramadol for safe and effective use. Review the full tramadol information here, and discuss this information and any questions with your doctor or other health care provider.