Tramadol is a prescription drug that treats moderate to severe pain. It belongs to a class of drugs called opioid agonists. Tramadol is a controlled substance. Learn more about what this means for you.
FDA Warnings
This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.
- Addiction and misuse: This drug can lead to addiction and misuse, which can result in overdose and death. To help avoid these problems, take this drug exactly as prescribed by your doctor. If you have any concerns about this warning, talk with your doctor.
- Slowed or stopped breathing: This drug can slow or stop your breathing. If this isn’t treated immediately, it can cause death. This risk is highest within three days of starting the drug or increasing your dosage.
- Accidental ingestion: If anyone, especially children, takes a dose of this drug by accident even once, it can cause death. This drug should be stored out of reach of children.
- Life threatening effects for children: In some cases, children’s bodies can process this drug too quickly. This can lead to slowed breathing and death. This drug should not be used in children younger than 12 years of age. It should also not be used in children younger than 18 years of age who have certain risk factors, or who have just had a tonsillectomy or adenoidectomy.
- Neonatal opioid withdrawal syndrome: If you use this medication for a long time while you’re pregnant, it can cause withdrawal in your baby. Withdrawal in your baby can lead to death. Symptoms of withdrawal can include irritability, hyperactivity, unusual sleep patterns, and a high-pitched cry. They can also include tremor, vomiting, diarrhea, and failure to gain weight.
- Interactions with certain drugs: Taking tramadol with certain drugs can cause varied serious effects. These effects include increased tramadol levels, possibly leading to seizures and serotonin syndrome. They also include reduced effectiveness of tramadol, and opioid withdrawal symptoms. The drugs that can cause these effects include amiodarone, quinidine, erythromycin, ketoconazole, ritonavir, and similar medications.
- Interactions with benzodiazepines: Taking tramadol with benzodiazepines and other similar drugs can cause very serious effects. These effects can include severe fatigue, slowed breathing, coma, and death.
Drug schedules typically take the form of Roman numerals rather than standard numbers, so you’ll often see them referred to as I, II, III, IV, or V rather than 1, 2, 3, 4, or 5.
Tramadol is a Schedule IV controlled drug, which means it has an accepted medical use for moderate to severe pain, but it may also cause physical or psychological dependence and has the potential for misuse and addiction. The FDA classified tramadol as Schedule IV controlled drug in
With misuse, you take a drug in a way other than how a doctor prescribes it. With addiction, you are unable to stop taking a drug, even though it may result in physical or physiological harm to you.
With Schedule IV drugs, the government has special rules for how doctors can prescribe drugs in this classification and how pharmacists can dispense them.
If you have questions or concerns about tramadol misuse or addiction, speak with your doctor.
Because there are risks linked to tramadol treatment, the FDA requires doctors to prescribe the drug through a risk evaluation and mitigation strategy (REMS) program.
Unlike other REMS programs, the tramadol REMS program does not require doctors or pharmacists to be certified specifically to prescribe or dispense this drug. However, the FDA’s Opioid Analgesic REMS program requires opioid manufacturers to offer education for healthcare providers to ensure safe prescribing.
While prescriber participation is optional, doctors are encouraged to discuss serious risks, proper use, storage, and disposal with patients. Pharmacists may also provide safety information each time you pick up your prescription.
For more information about the REMS program, talk with your doctor or pharmacist. You may also learn more about it on the Opioid Analgesic REMS website or by calling 800-503-0784.
Tramadol is classified as a Schedule IV controlled substance. It can be effective at relieving moderate to severe pain, but it’s important to follow your doctor’s instructions when taking it and be aware of any risks related to it.
If you have questions or concerns about taking tramadol, talk with your doctor.
