No black box warning on record for Pirfenidone

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

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the post-marketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and du

No black box warning on record for Pirfenidone

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the post-marketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and du

Pirfenidone Black Box Warning

No black box warning on record for Pirfenidone

Other warnings & precautions

Pirfenidone Black Box Warning

No black box warning on record for Pirfenidone

Other warnings & precautions