TRAMADOL WARNINGS

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

• Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone. 

•  Prescribe ULTRAM ER with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.

• Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.

Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with use of tramadol products, including ULTRAM ER, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, with drugs which impair metabolism of serotonin (including MAOIs) and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).