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warnings
WARNINGS Serotonin syndrome (SS), which is potentially life-threatening, has been reported with metaxalone use. These reports generally occurred when metaxalone was used concomitantly with serotonergic drugs (such as tramadol or selective serotonin reuptake inhibitors (SSRIs)) or when metaxalone was used at doses higher than the recommended dose (see Drug Interactions and OVERDOSAGE ). Signs of SS may include clonus, agitation, diaphoresis, tremor, hyperreflexia, hypertonia, and temperature elevation. Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
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.