No black box warning on record for Elmiron

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

Other warnings & precautions

WARNINGS Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON ® (see ADVERSE REACTIONS ). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor

No black box warning on record for Elmiron

Other warnings & precautions

WARNINGS Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON ® (see ADVERSE REACTIONS ). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor

Elmiron Black Box Warning

No black box warning on record for Elmiron

Other warnings & precautions

Elmiron Black Box Warning

No black box warning on record for Elmiron

Other warnings & precautions