Tramadol and Safinamide Interaction

Drug interaction information between Tramadol and Safinamide.

Tramadol and Safinamide have a documented major interaction in FDA labeling.

FDA drug labeling documents a major-severity interaction between Tramadol and Safinamide. This page displays the available source-record category and label text. The category is not an individual risk estimate or medication-combination direction.

Drug A

Tramadol

Opioid Analgesic

Drug B

Safinamide

MAO-B Inhibitor

How They Interact

Combining these drugs can cause a dangerous buildup of serotonin in the brain, which may lead to a life-threatening reaction.

FDA Label Information

7.2 Opioid Drugs Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs is contraindicated [see Warnings and Precautions (5.2) ] .

Frequently Asked Questions

What SPL severity band is on file for Tramadol + Safinamide?

Compiled FDA labeling labels this pair major. That is a source-record field, not an individual medication-combination decision.

Which drug in this pair has the larger labeled-interaction portfolio?

Tramadol has 38 labeled pairs on file vs Safinamide's 10. In the major band specifically: Tramadol has 1; Safinamide has 6 (also Methylphenidate, Linezolid, Methadone, Meperidine).

What mechanism field is on file for Tramadol and Safinamide?

Combining these drugs can cause a dangerous buildup of serotonin in the brain, which may lead to a life-threatening reaction.

Safinamide carries more major-labeled pairs than Tramadol

SPL source-record counts only. This page's band is major · classes on file: Tramadol (Opioid Analgesic); Safinamide (MAO-B Inhibitor).

Safinamide has 6 major-labeled pairs vs Tramadol's 1.

Tramadol

1 major · 3 moderate · 34 minor · 38 total

Tramadol has no other major-band peer in this dataset besides Safinamide.

Safinamide

6 major · 0 moderate · 4 minor · 10 total

Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. This registry does not provide individual medication-combination directions.