From the Guidelines
Tramadol is not safe for use in children under 6 years of age due to the risk of life-threatening respiratory depression and other serious side effects. The FDA guidelines, as endorsed by an expert panel opinion in JAMA Surgery 1, contraindicate the use of tramadol in children younger than 12 years, and this warning is particularly relevant for children under 6 years old. The risk of serious breathing problems, including reduced or slow breathing, is a major concern in this age group, as reported by the FDA in 2015. Children under 6 are at higher risk for these adverse effects because they metabolize tramadol differently than adults, and may be "ultra-rapid metabolizers," leading to dangerously high levels of the active form of the medication in the bloodstream.
For pain management in children under 12, especially those under 6, healthcare providers typically recommend alternatives such as:
- Acetaminophen
- Ibuprofen (for children over 6 months)
- Other pain medications specifically studied and approved for pediatric use. Any pain medication for children should only be given under direct medical supervision with appropriate weight-based dosing, as emphasized by the FDA guidelines regarding limited use of tramadol and codeine in children 1.
From the FDA Drug Label
The safety and efficacy of tramadol hydrochloride in patients under 16 years of age have not been established. The use of tramadol hydrochloride in the pediatric population is not recommended
The FDA drug label does not provide information to support the safe use of tramadol in children below 6 years of age. Tramadol is not recommended for use in the pediatric population, and its safety and efficacy in patients under 16 years of age have not been established 2.
From the Research
Tramadol Safety in Children Under 12 Years Old
- The use of tramadol in children under 12 years old is a concern due to the risk of respiratory depression and other adverse effects 3.
- According to the US Food and Drug Administration, tramadol is contraindicated in patients under the age of 12 years due to the risk of fatal overdoses linked to the variable activity of cytochrome P450 (CYP) 2D6 3.
- A study published in 2018 recommended a personalized approach to tramadol prescription in children, with dose adaptation according to CYP2D6 activity, to ensure safe and effective treatment 4.
Tramadol Safety in Children Under 6 Years Old
- There is limited data on the safety of tramadol in children under 6 years old, but a study published in 2019 found that seizures and respiratory depression are uncommon in pediatric tramadol ingestions, with median doses for respiratory depression and seizure being 225mg and 525mg, respectively 5.
- The same study found that the minimum weight-based dose for respiratory depression/arrest was 7.9 mg/kg and for seizures, 4.8 mg/kg, but more studies are needed to determine the minimum dose at which medical management is recommended 5.
- Another study published in 2024 found that children and adolescents are at a higher risk of tramadol-related acute central respiratory depression (ACRD) compared to adults, and that concomitant use of CYP2D6 inhibitors, opioids, benzodiazepines, and anti-depressant drugs increases the risk of ACRD 6.
General Safety Considerations
- Tramadol is a mixed-mechanism opioid drug that can cause life-threatening toxicity in overdose, and its use should be carefully considered in all patients, especially children and adolescents 7.
- Physicians should be aware of the potential risks and benefits of tramadol and use it only when necessary, with careful monitoring and dose adjustment as needed 7.