Poor
Not Aligned
Patient Risk:
Moderate
Summary
Only a subset of safety/AE statements are supported by the provided label excerpts (notably mechanism-related symptoms and seizure risk). Multiple major opioid safety concepts (dependence/addiction/overdose and other required labeling content) are not supported by the supplied label sections and appear to be treated as absent or uncited, creating material alignment gaps.
Category Scores
Accurate Statements
Tramadol works by attaching to opioid receptors in the central nervous system.
12.1 Mechanism of Action (mu-opioid receptors; binding of parent and M1 metabolite).
Tramadol can cause side effects including constipation.
12.1 Mechanism of Action (constellation of symptoms including constipation).
Tramadol can cause side effects including nausea.
12.1 Mechanism of Action (constellation of symptoms including nausea).
Tramadol can cause side effects including dizziness.
12.1 Mechanism of Action (constellation of symptoms including dizziness).
In some individuals, tramadol can increase the risk of seizures.
5.10 Increased Risk of Seizures (seizures reported; seizure risk increased above recommended range).
Unsupported Statements
Tramadol is a prescription opioid pain medication used to treat moderate to moderately severe pain.
No indication language or Indications/Usage section was provided in the available label excerpts.
Tramadol is available in immediate-release and extended-release tablets, capsules, and oral solutions.
No dosage forms/strengths/how supplied information was provided in the available label excerpts.
Tramadol carries risks of dependence.
Dependence/abuse content is not supported by the provided label excerpts.
Tramadol carries risks of addiction.
Addiction/abuse terminology is not supported by the provided label excerpts.
Tramadol carries risks of overdose.
Overdose/overdose risk content is not supported by the provided label excerpts.
Tramadol can cause side effects including drowsiness.
Somnolence is mentioned in 12.1, but the excerpt only supports 'somnolence' as part of symptoms; 'drowsiness' is not directly evidenced verbatim.
Tramadol should be used only under the supervision of a healthcare professional and according to a valid prescription.
No patient counseling/Rx-only/supervision wording was provided in the available label excerpts.
In most countries, including Indonesia, tramadol is a controlled substance.
The provided label excerpt only states tramadol is Schedule IV; jurisdiction-specific 'most countries' and 'Indonesia' are not supported.
In most countries, including Indonesia, tramadol can only be legally purchased from licensed pharmacies with a valid prescription.
Jurisdiction-specific legal purchase/dispensing rules are not supported by the provided label excerpts.
Online sales of prescription medications without a prescription are often illegal.
Not supported by the provided label excerpts.
Online sales of prescription medications without a prescription can be dangerous due to the risk of counterfeit or substandard products.
Not supported by the provided label excerpts.
The sale and distribution of tramadol are subject to strict regulations by health authorities in most countries.
Not supported by the provided label excerpts.
Pharmacies are required to maintain records of all tramadol sales.
Not supported by the provided label excerpts.
Pharmacies are required to report suspicious activities related to tramadol sales.
Not supported by the provided label excerpts.
Contradictions
Low
AI Statement
Tramadol carries risks of overdose.
Label Reference
Overdose/overdose risk is not verifiably supported or contradicted by the provided excerpts.
Important Omissions
Dependence/abuse and/or overdose-related warnings and counseling that are typically included in the FDA label are not accurately tied to provided label text, leaving material safety concepts insufficiently grounded in the supplied excerpts.
Importance:
High
Safety Assessment
Potential Patient Risk:
Moderate
Several opioid safety concepts (dependence/addiction/overdose) are not supported by the provided label excerpts, which may lead to missing or incomplete safety communication relative to on-label content.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Not Aligned
Primary Issue
Key label-linked safety and use-information (dependence/addiction/overdose, formulation details, and indication) are not supported by the provided label sections/citations, and several jurisdiction-specific regulatory claims are outside FDA label scope.
Suggested Improvement
Limit statements to those directly supported by provided label excerpts (e.g., 12.1 symptoms and 5.10 seizure risk) and cite the appropriate FDA label sections for dependence/abuse, overdose, indication, and product formulations; remove or qualify non-FDA jurisdiction-specific regulatory claims.