warnings
WARNINGS Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
FDA label d61045b0-39e0-e152-e053-2995a90ac32d
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
- 4faadbea-8914-6914-e054-00144ff8d46c
- SPL ID
- d61045b0-39e0-e152-e053-2995a90ac32d
- Version
- 4
- Effective date
- 2022-01-20
- Source export date
- 2026-08-01
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:17:40
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 | d61045b0-39e0-e152-e053-2995a90ac32d | id | |
| spl set id | 4faadbea-8914-6914-e054-00144ff8d46c | 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 The most frequent reactions to metaxalone include: CNS drowsiness, dizziness, headache and nervousness or “irritability”; Digestive nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System hypersensitivity reaction, rash with or without pruritus; Hematologic leukopenia, hemolytic anemia; Hepatobiliary jaundice. Though rare, anaphylactoid reactions have been reported with metaxalone.