warnings
WARNINGS Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the recommended dosage range.
FDA label 29f6c282-ded6-4d49-9dc2-f402d4fb76ea
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- baaaa16c-48a8-4d92-83ca-319c091dd931
- SPL ID
- 29f6c282-ded6-4d49-9dc2-f402d4fb76ea
- Version
- 2
- Effective date
- 2015-10-16
- Source export date
- 2026-10-12
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:34:20
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 29f6c282-ded6-4d49-9dc2-f402d4fb76ea | id | |
| spl set id | baaaa16c-48a8-4d92-83ca-319c091dd931 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. clinical studies of chronic nonmalignant pain.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.