No black box warning on record for Skyclarys

As of the latest FDA labeling reviewed, Skyclarys (OMAVELOXOLONE) does not carry a black box warning. Standard warnings and precautions still apply — see the full Skyclarys medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevation of Aminotransferases: Monitor ALT, AST, and total bilirubin prior to initiation, every month for the first 3 months of treatment, and periodically thereafter. ( 2.1 , 5.1 ) Elevation of B-type Natriuretic Peptide (BNP): Advise patients of signs and symptoms of fluid overload. ( 2.1 , 5.2 ) Lipid Abnormalities: Monitor cholesterol periodically during treatment.

No black box warning on record for Skyclarys

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevation of Aminotransferases: Monitor ALT, AST, and total bilirubin prior to initiation, every month for the first 3 months of treatment, and periodically thereafter. ( 2.1 , 5.1 ) Elevation of B-type Natriuretic Peptide (BNP): Advise patients of signs and symptoms of fluid overload. ( 2.1 , 5.2 ) Lipid Abnormalities: Monitor cholesterol periodically during treatment.

Skyclarys Black Box Warning

No black box warning on record for Skyclarys

Other warnings & precautions

Skyclarys Black Box Warning

No black box warning on record for Skyclarys

Other warnings & precautions