SKELAXIN® Adverse Reactions

(metaxalone)

6 ADVERSE REACTIONS

The following adverse reactions associated with the use of SKELAXIN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent reactions to metaxalone were:

CNS: drowsiness, dizziness, headache, and nervousness or "irritability".
Digestive: nausea, vomiting, gastrointestinal upset.

Other adverse reactions were:

CNS: cases of serotonin syndrome have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs and with the use of SKELAXIN as the only serotonergic drug at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Overdosage (10)].
Hematologic: leukopenia; hemolytic anemia;
Hepatobiliary: jaundice;
Immune System: anaphylaxis, hypersensitivity reaction, rash with or without pruritus.

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Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions associated with the use of SKELAXIN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent reactions to metaxalone were:

CNS: drowsiness, dizziness, headache, and nervousness or "irritability".
Digestive: nausea, vomiting, gastrointestinal upset.

Other adverse reactions were:

CNS: cases of serotonin syndrome have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs and with the use of SKELAXIN as the only serotonergic drug at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Overdosage (10)].
Hematologic: leukopenia; hemolytic anemia;
Hepatobiliary: jaundice;
Immune System: anaphylaxis, hypersensitivity reaction, rash with or without pruritus.
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