No black box warning on record for Tramadol

As of the latest FDA labeling reviewed, Tramadol (tramadol hydrochloride) does not carry a black box warning. Standard warnings and precautions still apply — see the full Tramadol medicine page for the complete safety profile.

Other warnings & precautions

Addiction, Abuse, and Misuse (Boxed Warning): Tramadol is a Schedule IV controlled substance with addiction potential. Risk is higher in patients with personal or family history of substance use disorder or mental illness.
Life-Threatening Respiratory Depression (Boxed Warning): Serious, life-threatening, or fatal respiratory depression can occur, especially upon initiation or dose escalation. Concomitant use with CNS depressants dramatically increases this risk.
Neonatal Opioid Withdrawal Syndrome (Boxed Warning): Prolonged use during pregnancy can cause neonatal withdrawal syndrome — potentially life-threatening if not recognized and managed.
Seizure Risk: Tramadol lowers the seizure threshold. Risk increases with doses above recommended range, concurrent use of serotonergic medicines, SSRIs, MAOIs, and in patients with prior seizure disorder. Tramadol is generally avoided in patients with epilepsy.
Serotonin Syndrome: Due to SNRI-like properties, tramadol can cause serotonin syndrome when combined with serotonergic medications. Serotonin syndrome is a medical emergency.
Post-tonsillectomy in children: Tramadol is contraindicated in pediatric patients (<17 years) after tonsillectomy and/or adenoidectomy following multiple post-operative deaths in CYP2D6 ultra-rapid metabolizers (who convert tramadol to high levels of opioid M1 metabolite).

Other warnings & precautions

Addiction, Abuse, and Misuse (Boxed Warning): Tramadol is a Schedule IV controlled substance with addiction potential. Risk is higher in patients with personal or family history of substance use disorder or mental illness.

Life-Threatening Respiratory Depression (Boxed Warning): Serious, life-threatening, or fatal respiratory depression can occur, especially upon initiation or dose escalation. Concomitant use with CNS depressants dramatically increases this risk.

Neonatal Opioid Withdrawal Syndrome (Boxed Warning): Prolonged use during pregnancy can cause neonatal withdrawal syndrome — potentially life-threatening if not recognized and managed.

Seizure Risk: Tramadol lowers the seizure threshold. Risk increases with doses above recommended range, concurrent use of serotonergic medicines, SSRIs, MAOIs, and in patients with prior seizure disorder. Tramadol is generally avoided in patients with epilepsy.

Serotonin Syndrome: Due to SNRI-like properties, tramadol can cause serotonin syndrome when combined with serotonergic medications. Serotonin syndrome is a medical emergency.

Post-tonsillectomy in children: Tramadol is contraindicated in pediatric patients (<17 years) after tonsillectomy and/or adenoidectomy following multiple post-operative deaths in CYP2D6 ultra-rapid metabolizers (who convert tramadol to high levels of opioid M1 metabolite).

Tramadol Black Box Warning

No black box warning on record for Tramadol

Other warnings & precautions

Tramadol Black Box Warning

No black box warning on record for Tramadol

Other warnings & precautions